Trial Outcomes & Findings for Pregnancy Intervention With a Closed-Loop System (PICLS) Study (NCT NCT03774186)
NCT ID: NCT03774186
Last Updated: 2023-11-28
Results Overview
Safety of HCL therapy compared to SAPT in women with T1D throughout gestation and the early post-partum period assessed through the number of episodes of severe hypoglycemia requiring 3rd party assistance
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
through study completion, an average of 9 months
Results posted on
2023-11-28
Participant Flow
Participant milestones
| Measure |
Sensor-augmented Pump Therapy (SAPT)
Pregnant women with T1D with use an insulin pump and a continuous glucose monitor but there will be no automated insulin adjustments made by the system.
Sensor-augmented pump therapy: Insulin pump + non-communicating CGM
|
Hybrid Closed-loop Therapy (HCL)
Pregnant women with T1D with use an insulin pump and a continuous glucose monitor with automated insulin adjustments made by the system, but continued meal boluses from the women.
Hybrid closed-loop therapy: Hybrid closed-loop therapy with a proportional integral derivative (PID) algorithm
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data not available for 3 participants
Baseline characteristics by cohort
| Measure |
Sensor-augmented Pump Therapy (SAPT)
n=12 Participants
Pregnant women with T1D with use an insulin pump and a continuous glucose monitor but there will be no automated insulin adjustments made by the system.
Sensor-augmented pump therapy: Insulin pump + non-communicating CGM
|
Hybrid Closed-loop Therapy (HCL)
n=12 Participants
Pregnant women with T1D with use an insulin pump and a continuous glucose monitor with automated insulin adjustments made by the system, but continued meal boluses from the women.
Hybrid closed-loop therapy: Hybrid closed-loop therapy with a proportional integral derivative (PID) algorithm
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.7 years
STANDARD_DEVIATION 3.5 • n=12 Participants
|
31.5 years
STANDARD_DEVIATION 4.9 • n=12 Participants
|
31.1 years
STANDARD_DEVIATION 4.2 • n=24 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=12 Participants
|
12 Participants
n=12 Participants
|
24 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Non Hispanic White
|
10 Participants
n=10 Participants • Data not available for 3 participants
|
11 Participants
n=11 Participants • Data not available for 3 participants
|
21 Participants
n=21 Participants • Data not available for 3 participants
|
|
Education
High School/General Education Development
|
0 Participants
n=11 Participants • Data missing for 1 in SAPT Group
|
1 Participants
n=12 Participants • Data missing for 1 in SAPT Group
|
1 Participants
n=23 Participants • Data missing for 1 in SAPT Group
|
|
Education
Some College
|
3 Participants
n=11 Participants • Data missing for 1 in SAPT Group
|
0 Participants
n=12 Participants • Data missing for 1 in SAPT Group
|
3 Participants
n=23 Participants • Data missing for 1 in SAPT Group
|
|
Education
Associate's Degree
|
0 Participants
n=11 Participants • Data missing for 1 in SAPT Group
|
0 Participants
n=12 Participants • Data missing for 1 in SAPT Group
|
0 Participants
n=23 Participants • Data missing for 1 in SAPT Group
|
|
Education
Bachelor's Degree
|
5 Participants
n=11 Participants • Data missing for 1 in SAPT Group
|
6 Participants
n=12 Participants • Data missing for 1 in SAPT Group
|
11 Participants
n=23 Participants • Data missing for 1 in SAPT Group
|
|
Education
Master's Degree
|
2 Participants
n=11 Participants • Data missing for 1 in SAPT Group
|
5 Participants
n=12 Participants • Data missing for 1 in SAPT Group
|
7 Participants
n=23 Participants • Data missing for 1 in SAPT Group
|
|
Education
Doctorate
|
1 Participants
n=11 Participants • Data missing for 1 in SAPT Group
|
0 Participants
n=12 Participants • Data missing for 1 in SAPT Group
|
1 Participants
n=23 Participants • Data missing for 1 in SAPT Group
|
|
Insurance Type
Medicaid
|
0 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
1 Participants
n=24 Participants
|
|
Insurance Type
Government
|
1 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
2 Participants
n=24 Participants
|
|
Insurance Type
Commercial
|
8 Participants
n=12 Participants
|
5 Participants
n=12 Participants
|
13 Participants
n=24 Participants
|
|
Insurance Type
Other
|
3 Participants
n=12 Participants
|
5 Participants
n=12 Participants
|
8 Participants
n=24 Participants
|
|
Multiparity
|
7 Participants
n=12 Participants
|
8 Participants
n=12 Participants
|
15 Participants
n=24 Participants
|
|
Tobacco Use
Former
|
3 Participants
n=11 Participants • Missing data for 1 in SAPT Group
|
1 Participants
n=12 Participants • Missing data for 1 in SAPT Group
|
4 Participants
n=23 Participants • Missing data for 1 in SAPT Group
|
|
Tobacco Use
Never
|
8 Participants
n=11 Participants • Missing data for 1 in SAPT Group
|
11 Participants
n=12 Participants • Missing data for 1 in SAPT Group
|
19 Participants
n=23 Participants • Missing data for 1 in SAPT Group
|
|
Insulin Pump Use Prior to Pregnancy
|
11 Participants
n=12 Participants
|
12 Participants
n=12 Participants
|
23 Participants
n=24 Participants
|
|
CGM Use Prior to Pregnancy
|
11 Participants
n=12 Participants
|
12 Participants
n=12 Participants
|
23 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: through study completion, an average of 9 monthsSafety of HCL therapy compared to SAPT in women with T1D throughout gestation and the early post-partum period assessed through the number of episodes of severe hypoglycemia requiring 3rd party assistance
Outcome measures
| Measure |
Sensor-augmented Pump Therapy (SAPT)
n=12 Participants
Pregnant women with T1D with use an insulin pump and a continuous glucose monitor but there will be no automated insulin adjustments made by the system.
Sensor-augmented pump therapy: Insulin pump + non-communicating CGM
|
Hybrid Closed-loop Therapy (HCL)
n=11 Participants
Pregnant women with T1D with use an insulin pump and a continuous glucose monitor with automated insulin adjustments made by the system, but continued meal boluses from the women.
Hybrid closed-loop therapy: Hybrid closed-loop therapy with a proportional integral derivative (PID) algorithm
|
|---|---|---|
|
Number of Episodes of Severe Hypoglycemia
|
0 Number of Episodes
|
0 Number of Episodes
|
PRIMARY outcome
Timeframe: Through study completion, an average of 9 monthsSafety of HCL therapy compared to SAPT in women with T1D throughout gestation and the early post-partum period assessed through continuous glucose monitor time spent with glucose \<54 mg/dL
Outcome measures
| Measure |
Sensor-augmented Pump Therapy (SAPT)
n=12 Participants
Pregnant women with T1D with use an insulin pump and a continuous glucose monitor but there will be no automated insulin adjustments made by the system.
Sensor-augmented pump therapy: Insulin pump + non-communicating CGM
|
Hybrid Closed-loop Therapy (HCL)
n=11 Participants
Pregnant women with T1D with use an insulin pump and a continuous glucose monitor with automated insulin adjustments made by the system, but continued meal boluses from the women.
Hybrid closed-loop therapy: Hybrid closed-loop therapy with a proportional integral derivative (PID) algorithm
|
|---|---|---|
|
Time Spent With Glucose <54 mg/dL
Time spent with glucose <54 mg/dL (1st Trimester)
|
3.98 percentage of time spent in range
Standard Error 0.668
|
4.04 percentage of time spent in range
Standard Error 0.683
|
|
Time Spent With Glucose <54 mg/dL
Time spent with glucose <54 mg/dL (2nd Trimester)
|
2.84 percentage of time spent in range
Standard Error 0.668
|
1.68 percentage of time spent in range
Standard Error 0.683
|
|
Time Spent With Glucose <54 mg/dL
Time spent with glucose <54 mg/dL (3rd Trimester)
|
2.01 percentage of time spent in range
Standard Error 0.668
|
1.23 percentage of time spent in range
Standard Error 0.683
|
|
Time Spent With Glucose <54 mg/dL
Time spent with glucose <54 mg/dL (Postpartum)
|
2.66 percentage of time spent in range
Standard Error 0.679
|
1.16 percentage of time spent in range
Standard Error 0.683
|
PRIMARY outcome
Timeframe: Through study completion, an average of 9 monthsIndices of glucose control are time spent in the glucose target ranges \<54 mg/dL and \<63 mg/dL (hypoglycemia), 63-140 mg/dL (time in range), and \>140 mg/dL and \>180 mg/dL (hyperglycemia) of HCL compared to SAPT in women with T1D throughout gestation and the first 4-6 weeks post-partum
Outcome measures
| Measure |
Sensor-augmented Pump Therapy (SAPT)
n=12 Participants
Pregnant women with T1D with use an insulin pump and a continuous glucose monitor but there will be no automated insulin adjustments made by the system.
Sensor-augmented pump therapy: Insulin pump + non-communicating CGM
|
Hybrid Closed-loop Therapy (HCL)
n=11 Participants
Pregnant women with T1D with use an insulin pump and a continuous glucose monitor with automated insulin adjustments made by the system, but continued meal boluses from the women.
Hybrid closed-loop therapy: Hybrid closed-loop therapy with a proportional integral derivative (PID) algorithm
|
|---|---|---|
|
Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring
Time spent <54 mg/ dL (1st Trimester)
|
3.98 percentage of time spent in range
Standard Error 0.668
|
4.04 percentage of time spent in range
Standard Error 0.683
|
|
Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring
Time spent <54 mg/ dL (2nd Trimester)
|
2.84 percentage of time spent in range
Standard Error 0.668
|
1.68 percentage of time spent in range
Standard Error 0.683
|
|
Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring
Time spent <54 mg/ dL (3rd Trimester)
|
2.01 percentage of time spent in range
Standard Error 0.668
|
1.23 percentage of time spent in range
Standard Error 0.683
|
|
Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring
Time spent <54 mg/ dL (Postpartum)
|
2.66 percentage of time spent in range
Standard Error 0.679
|
1.16 percentage of time spent in range
Standard Error 0.683
|
|
Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring
Time spent <63 mg/ dL (1st trimester)
|
8.07 percentage of time spent in range
Standard Error 1.15
|
7.46 percentage of time spent in range
Standard Error 1.18
|
|
Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring
Time spent <63 mg/ dL (2nd trimester)
|
6.26 percentage of time spent in range
Standard Error 1.15
|
3.52 percentage of time spent in range
Standard Error 1.18
|
|
Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring
Time spent <63 mg/ dL (3rd trimester)
|
5.05 percentage of time spent in range
Standard Error 1.15
|
2.81 percentage of time spent in range
Standard Error 1.18
|
|
Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring
Time spent <63 mg/ dL (Postpartum)
|
5.60 percentage of time spent in range
Standard Error 1.17
|
2.58 percentage of time spent in range
Standard Error 1.18
|
|
Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring
Time spent 63-140 mg/ dL (1st Trimester)
|
62.2 percentage of time spent in range
Standard Error 2.95
|
61.7 percentage of time spent in range
Standard Error 3.02
|
|
Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring
Time spent 63-140 mg/ dL (2nd Trimester)
|
60.6 percentage of time spent in range
Standard Error 2.95
|
57.3 percentage of time spent in range
Standard Error 3.02
|
|
Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring
Time spent 63-140 mg/ dL (3rd Trimester)
|
68.3 percentage of time spent in range
Standard Error 2.95
|
61.8 percentage of time spent in range
Standard Error 3.02
|
|
Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring
Time spent 63-140 mg/ dL (Postpartum)
|
59.0 percentage of time spent in range
Standard Error 3.00
|
52.7 percentage of time spent in range
Standard Error 3.02
|
|
Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring
Time spent >140 mg/ dL (1st Trimester)
|
30.9 percentage of time spent in range
Standard Error 3.27
|
31.9 percentage of time spent in range
Standard Error 3.35
|
|
Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring
Time spent >140 mg/ dL (2nd Trimester)
|
34.4 percentage of time spent in range
Standard Error 3.27
|
40.2 percentage of time spent in range
Standard Error 3.35
|
|
Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring
Time spent >140 mg/ dL (3rd Trimester)
|
27.8 percentage of time spent in range
Standard Error 3.27
|
36.4 percentage of time spent in range
Standard Error 3.35
|
|
Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring
Time spent >140 mg/ dL (Postpartum)
|
36.5 percentage of time spent in range
Standard Error 3.33
|
45.7 percentage of time spent in range
Standard Error 3.35
|
|
Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring
Time spent >180 mg/ dL (1st Trimester)
|
12.75 percentage of time spent in range
Standard Error 2.27
|
14.62 percentage of time spent in range
Standard Error 2.32
|
|
Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring
Time spent >180 mg/ dL (2nd Trimester)
|
13.05 percentage of time spent in range
Standard Error 2.27
|
17.80 percentage of time spent in range
Standard Error 2.32
|
|
Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring
Time spent >180 mg/ dL (3rd Trimester)
|
8.44 percentage of time spent in range
Standard Error 2.27
|
13.75 percentage of time spent in range
Standard Error 2.32
|
|
Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring
Time spent >180 mg/ dL (Postpartum)
|
15.31 percentage of time spent in range
Standard Error 2.31
|
21.08 percentage of time spent in range
Standard Error 2.32
|
PRIMARY outcome
Timeframe: Through study completion, an average of 9 monthsFear of hypoglycemia is assessed as behavior, worry, and total scores of fear of hypoglycemia determined by the Hypoglycemia Fear Survey of HCL compared to SAPT in women with T1D throughout gestation and the first 4-6 weeks post-partum. Score Explanation: Change(s) in behavior and/or concerns of diabetics as detected by the hypoglycemia fear questionnaire. Behavior sub-scale score ranges from 10-50, with higher scores indicating more behavioral changes in the participant's daily routine to avoid low blood sugar. Worry sub-scale score ranges from 17-85, with higher scores indicating more worry or concerns because of low blood sugar. Total score ranges from 27-135, with higher scores for both sub-scales indicating more fear and a worse outcome. Subscales are added for the total scale score. Time Points: Baseline: 9 weeks gestation or earlier Visit 7: 18-20 weeks gestation Visit 10: 30-32 weeks gestation Visit 16: 4-6 weeks after delivery
Outcome measures
| Measure |
Sensor-augmented Pump Therapy (SAPT)
n=12 Participants
Pregnant women with T1D with use an insulin pump and a continuous glucose monitor but there will be no automated insulin adjustments made by the system.
Sensor-augmented pump therapy: Insulin pump + non-communicating CGM
|
Hybrid Closed-loop Therapy (HCL)
n=11 Participants
Pregnant women with T1D with use an insulin pump and a continuous glucose monitor with automated insulin adjustments made by the system, but continued meal boluses from the women.
Hybrid closed-loop therapy: Hybrid closed-loop therapy with a proportional integral derivative (PID) algorithm
|
|---|---|---|
|
Fear of Hypoglycemia Score
Total Score Baseline
|
69.4 score on a scale
Standard Error 5.30
|
69.0 score on a scale
Standard Error 5.12
|
|
Fear of Hypoglycemia Score
Total Score Visit 7
|
69.0 score on a scale
Standard Error 5.41
|
60.5 score on a scale
Standard Error 5.27
|
|
Fear of Hypoglycemia Score
Total Score Visit 10
|
67.3 score on a scale
Standard Error 5.40
|
64.7 score on a scale
Standard Error 5.35
|
|
Fear of Hypoglycemia Score
Total Score Visit 16 (postpartum)
|
68.0 score on a scale
Standard Error 5.40
|
65.3 score on a scale
Standard Error 5.42
|
|
Fear of Hypoglycemia Score
Worry Score Baseline
|
40.0 score on a scale
Standard Error 4.26
|
39.4 score on a scale
Standard Error 4.10
|
|
Fear of Hypoglycemia Score
Worry Score Visit 7
|
38.3 score on a scale
Standard Error 4.37
|
31.6 score on a scale
Standard Error 4.26
|
|
Fear of Hypoglycemia Score
Worry Score Visit 10
|
38.1 score on a scale
Standard Error 4.36
|
35.9 score on a scale
Standard Error 4.34
|
|
Fear of Hypoglycemia Score
Worry Score Visit 16 (postpartum)
|
38.2 score on a scale
Standard Error 4.36
|
37.6 score on a scale
Standard Error 4.42
|
|
Fear of Hypoglycemia Score
Behavior Score Baseline
|
29.8 score on a scale
Standard Error 1.85
|
29.5 score on a scale
Standard Error 1.79
|
|
Fear of Hypoglycemia Score
Behavior Score Visit 7
|
29.9 score on a scale
Standard Error 1.90
|
29.1 score on a scale
Standard Error 1.89
|
|
Fear of Hypoglycemia Score
Behavior Score Visit 10
|
29.0 score on a scale
Standard Error 1.94
|
28.4 score on a scale
Standard Error 1.89
|
|
Fear of Hypoglycemia Score
Behavior Score Visit 16 (postpartum)
|
29.6 score on a scale
Standard Error 1.94
|
27.7 score on a scale
Standard Error 2.00
|
SECONDARY outcome
Timeframe: Through study completion, an average of 9 monthsSecondary safety assessed through the number of episodes of diabetic ketoacidosis of HCL therapy compared to SAPT in women with T1D throughout gestation and the early post-partum period.
Outcome measures
| Measure |
Sensor-augmented Pump Therapy (SAPT)
n=12 Participants
Pregnant women with T1D with use an insulin pump and a continuous glucose monitor but there will be no automated insulin adjustments made by the system.
Sensor-augmented pump therapy: Insulin pump + non-communicating CGM
|
Hybrid Closed-loop Therapy (HCL)
n=12 Participants
Pregnant women with T1D with use an insulin pump and a continuous glucose monitor with automated insulin adjustments made by the system, but continued meal boluses from the women.
Hybrid closed-loop therapy: Hybrid closed-loop therapy with a proportional integral derivative (PID) algorithm
|
|---|---|---|
|
Number of Episodes of Diabetic Ketoacidosis
|
0 Number of Episodes
|
1 Number of Episodes
|
SECONDARY outcome
Timeframe: through study completion, an average of 9 monthsSecondary safety assessed through the number of adverse skin reactions of HCL therapy compared to SAPT in women with T1D throughout gestation and the early post-partum period
Outcome measures
| Measure |
Sensor-augmented Pump Therapy (SAPT)
n=12 Participants
Pregnant women with T1D with use an insulin pump and a continuous glucose monitor but there will be no automated insulin adjustments made by the system.
Sensor-augmented pump therapy: Insulin pump + non-communicating CGM
|
Hybrid Closed-loop Therapy (HCL)
n=12 Participants
Pregnant women with T1D with use an insulin pump and a continuous glucose monitor with automated insulin adjustments made by the system, but continued meal boluses from the women.
Hybrid closed-loop therapy: Hybrid closed-loop therapy with a proportional integral derivative (PID) algorithm
|
|---|---|---|
|
Number of Adverse Skin Reactions
|
5 Number of Reactions
|
1 Number of Reactions
|
SECONDARY outcome
Timeframe: through study completion, an average of 9 monthsPopulation: The HCL group had 11 participants complete the study after randomization
Secondary outcomes of indices of glycemic variability by continuous glucose monitoring as mean glucose ± standard deviation in pregnant women with T1D using HCL or SAPT therapy throughout pregnancy and early post-partum
Outcome measures
| Measure |
Sensor-augmented Pump Therapy (SAPT)
n=12 Participants
Pregnant women with T1D with use an insulin pump and a continuous glucose monitor but there will be no automated insulin adjustments made by the system.
Sensor-augmented pump therapy: Insulin pump + non-communicating CGM
|
Hybrid Closed-loop Therapy (HCL)
n=12 Participants
Pregnant women with T1D with use an insulin pump and a continuous glucose monitor with automated insulin adjustments made by the system, but continued meal boluses from the women.
Hybrid closed-loop therapy: Hybrid closed-loop therapy with a proportional integral derivative (PID) algorithm
|
|---|---|---|
|
Secondary Indices of Glucose Control: Mean Glucose ± Standard Deviation
1st Trimester
|
122 mg/dL
Standard Deviation 4
|
125 mg/dL
Standard Deviation 4
|
|
Secondary Indices of Glucose Control: Mean Glucose ± Standard Deviation
2nd Trimester
|
126 mg/dL
Standard Deviation 4
|
137 mg/dL
Standard Deviation 4
|
|
Secondary Indices of Glucose Control: Mean Glucose ± Standard Deviation
3rd Trimester
|
120 mg/dL
Standard Deviation 4
|
132 mg/dL
Standard Deviation 4
|
|
Secondary Indices of Glucose Control: Mean Glucose ± Standard Deviation
Postpartum
|
130 mg/dL
Standard Deviation 4
|
144 mg/dL
Standard Deviation 4
|
SECONDARY outcome
Timeframe: through study completion, an average of 9 monthsPopulation: The HCL group had 11 participants complete the study after randomization
Secondary outcomes of indices of glycemic variability by continuous glucose monitoring as J index in pregnant women with T1D using HCL or SAPT therapy throughout pregnancy and early post-partum. J index is a measure of the quality of glycemic control. Lower values represent more glycemic control and higher values represent less glycemic control. Formula: J-Index= 0.001 x (mean blood glucose level + SD)\^2 The J-Index has not been validated in this population of Type 1 Diabetes pregnancies.
Outcome measures
| Measure |
Sensor-augmented Pump Therapy (SAPT)
n=12 Participants
Pregnant women with T1D with use an insulin pump and a continuous glucose monitor but there will be no automated insulin adjustments made by the system.
Sensor-augmented pump therapy: Insulin pump + non-communicating CGM
|
Hybrid Closed-loop Therapy (HCL)
n=12 Participants
Pregnant women with T1D with use an insulin pump and a continuous glucose monitor with automated insulin adjustments made by the system, but continued meal boluses from the women.
Hybrid closed-loop therapy: Hybrid closed-loop therapy with a proportional integral derivative (PID) algorithm
|
|---|---|---|
|
Secondary Indices of Glucose Control: J-index
J-Index (Run-In Phase)
|
26.2 mg/dL
Standard Error 2.25
|
29.5 mg/dL
Standard Error 2.31
|
|
Secondary Indices of Glucose Control: J-index
J-Index (1st Trimester)
|
29.3 mg/dL
Standard Error 2.25
|
32.0 mg/dL
Standard Error 2.31
|
|
Secondary Indices of Glucose Control: J-index
J-Index (2nd Trimester)
|
29.5 mg/dL
Standard Error 2.25
|
34.6 mg/dL
Standard Error 2.31
|
|
Secondary Indices of Glucose Control: J-index
J-Index (3rd Trimester)
|
25.1 mg/dL
Standard Error 2.25
|
30.7 mg/dL
Standard Error 2.31
|
|
Secondary Indices of Glucose Control: J-index
J-Index (Post-Partum)
|
32.1 mg/dL
Standard Error 2.30
|
38.0 mg/dL
Standard Error 2.31
|
SECONDARY outcome
Timeframe: through study completion, an average of 9 monthsPopulation: The HCL group had 11 participants complete the study after randomization
Secondary outcomes of indices of glycemic variability by continuous glucose monitoring as High Blood Glucose Index (HBGI) in pregnant women with T1D using HCL or SAPT therapy throughout pregnancy and early post-partum. HBGI is a Glucose-variability-based metric of the risk for hyperglycemia that can be calculated from CGM readings. HBGI increases with the frequency and extent of hyperglycemic excursions and has been used as a predictor of severe events. The range of values is 0-100 with 0 indicating no risk of high blood sugar and 100 indicating maximum possible risk of high blood sugar.
Outcome measures
| Measure |
Sensor-augmented Pump Therapy (SAPT)
n=12 Participants
Pregnant women with T1D with use an insulin pump and a continuous glucose monitor but there will be no automated insulin adjustments made by the system.
Sensor-augmented pump therapy: Insulin pump + non-communicating CGM
|
Hybrid Closed-loop Therapy (HCL)
n=12 Participants
Pregnant women with T1D with use an insulin pump and a continuous glucose monitor with automated insulin adjustments made by the system, but continued meal boluses from the women.
Hybrid closed-loop therapy: Hybrid closed-loop therapy with a proportional integral derivative (PID) algorithm
|
|---|---|---|
|
Secondary Indices of Glucose Control: High Blood Glucose Index (HBGI)
HBGI (Run-In Phase)
|
4.54 score on a scale
Standard Error 0.604
|
5.32 score on a scale
Standard Error 0.618
|
|
Secondary Indices of Glucose Control: High Blood Glucose Index (HBGI)
HBGI (1st Trimester)
|
5.23 score on a scale
Standard Error 0.604
|
6.12 score on a scale
Standard Error 0.618
|
|
Secondary Indices of Glucose Control: High Blood Glucose Index (HBGI)
HBGI (2nd Trimester)
|
4.78 score on a scale
Standard Error 0.604
|
5.61 score on a scale
Standard Error 0.618
|
|
Secondary Indices of Glucose Control: High Blood Glucose Index (HBGI)
HBGI (3rd Trimester)
|
3.57 score on a scale
Standard Error 0.604
|
4.58 score on a scale
Standard Error 0.618
|
|
Secondary Indices of Glucose Control: High Blood Glucose Index (HBGI)
HBGI (Post-Partum)
|
5.70 score on a scale
Standard Error 0.615
|
6.42 score on a scale
Standard Error 0.618
|
SECONDARY outcome
Timeframe: through study completion, an average of 9 monthsPopulation: The HCL group had 11 participants complete the study after randomization
Secondary outcomes of indices of glycemic variability by continuous glucose monitoring as Low Blood Glucose Index (LBGI) in pregnant women with T1D using HCL or SAPT therapy throughout pregnancy and early post-partum. LBGI is a Glucose-variability-based metric of the risk for hypoglycemia. LBGI increases with the frequency and extent of hypoglycemic excursions and has been used as a predictor of severe events. The range is from 0-100 with 0 indicating no risk of low blood sugar and 100 indicating maximum possible risk of low blood sugar.
Outcome measures
| Measure |
Sensor-augmented Pump Therapy (SAPT)
n=12 Participants
Pregnant women with T1D with use an insulin pump and a continuous glucose monitor but there will be no automated insulin adjustments made by the system.
Sensor-augmented pump therapy: Insulin pump + non-communicating CGM
|
Hybrid Closed-loop Therapy (HCL)
n=12 Participants
Pregnant women with T1D with use an insulin pump and a continuous glucose monitor with automated insulin adjustments made by the system, but continued meal boluses from the women.
Hybrid closed-loop therapy: Hybrid closed-loop therapy with a proportional integral derivative (PID) algorithm
|
|---|---|---|
|
Secondary Indices of Glucose Control: Low Blood Glucose Index (LBGI)
LBGI (Run-In Phase)
|
5.48 score on a scale
Standard Error 0.516
|
5.67 score on a scale
Standard Error 0.528
|
|
Secondary Indices of Glucose Control: Low Blood Glucose Index (LBGI)
LBGI (1st Trimester)
|
5.40 score on a scale
Standard Error 0.516
|
5.92 score on a scale
Standard Error 0.528
|
|
Secondary Indices of Glucose Control: Low Blood Glucose Index (LBGI)
LBGI (2nd Trimester)
|
4.83 score on a scale
Standard Error 0.516
|
4.09 score on a scale
Standard Error 0.528
|
|
Secondary Indices of Glucose Control: Low Blood Glucose Index (LBGI)
LBGI (3rd Trimester)
|
4.06 score on a scale
Standard Error 0.516
|
3.44 score on a scale
Standard Error 0.528
|
|
Secondary Indices of Glucose Control: Low Blood Glucose Index (LBGI)
LBGI (Post-Partum)
|
4.86 score on a scale
Standard Error 0.525
|
3.69 score on a scale
Standard Error 0.528
|
SECONDARY outcome
Timeframe: through study completion, an average of 9 monthsPopulation: The HCL group had 11 participants complete the study after randomization
Secondary outcomes of indices of glycemic variability by continuous glucose monitoring as Mean Amplitude of Glycemic Excursions (MAGE) in pregnant women with T1D using HCL or SAPT therapy throughout pregnancy and early post-partum. MAGE is the average difference between consecutive glucose peaks and nadirs greater than 1 standard deviation (SD) of the average value of glucose in a given day. Lower values represent less glycemic variability on average. Higher values represent more glycemic variability on average.
Outcome measures
| Measure |
Sensor-augmented Pump Therapy (SAPT)
n=12 Participants
Pregnant women with T1D with use an insulin pump and a continuous glucose monitor but there will be no automated insulin adjustments made by the system.
Sensor-augmented pump therapy: Insulin pump + non-communicating CGM
|
Hybrid Closed-loop Therapy (HCL)
n=12 Participants
Pregnant women with T1D with use an insulin pump and a continuous glucose monitor with automated insulin adjustments made by the system, but continued meal boluses from the women.
Hybrid closed-loop therapy: Hybrid closed-loop therapy with a proportional integral derivative (PID) algorithm
|
|---|---|---|
|
Secondary Indices of Glucose Control: Mean Amplitude of Glycemic Excursions (MAGE)
MAGE (Run-In Phase)
|
84.4 mg/dL
Standard Error 5.47
|
98.8 mg/dL
Standard Error 5.61
|
|
Secondary Indices of Glucose Control: Mean Amplitude of Glycemic Excursions (MAGE)
MAGE (1st Trimester)
|
91.9 mg/dL
Standard Error 5.47
|
100.9 mg/dL
Standard Error 5.61
|
|
Secondary Indices of Glucose Control: Mean Amplitude of Glycemic Excursions (MAGE)
MAGE (2nd Trimester)
|
85.4 mg/dL
Standard Error 5.47
|
94.5 mg/dL
Standard Error 5.61
|
|
Secondary Indices of Glucose Control: Mean Amplitude of Glycemic Excursions (MAGE)
MAGE (3rd Trimester)
|
69.2 mg/dL
Standard Error 5.47
|
81.8 mg/dL
Standard Error 5.61
|
|
Secondary Indices of Glucose Control: Mean Amplitude of Glycemic Excursions (MAGE)
MAGE (Post-Partum)
|
92.9 mg/dL
Standard Error 5.59
|
99.5 mg/dL
Standard Error 5.61
|
SECONDARY outcome
Timeframe: through study completion, an average of 9 monthsPopulation: The HCL group had 11 participants complete the study after randomization
Secondary outcomes of indices of glycemic variability by continuous glucose monitoring as Continuous Overall Net Glycemic Action (CONGAn) in pregnant women with T1D using HCL or SAPT therapy throughout pregnancy and early post-partum. CONGAn assesses glycemic variability by calculating the difference between the glucose values taken at different timeframes. Lower values represent less glycemic differences between the timepoints. Higher values represent more glycemic differences between timepoints.
Outcome measures
| Measure |
Sensor-augmented Pump Therapy (SAPT)
n=12 Participants
Pregnant women with T1D with use an insulin pump and a continuous glucose monitor but there will be no automated insulin adjustments made by the system.
Sensor-augmented pump therapy: Insulin pump + non-communicating CGM
|
Hybrid Closed-loop Therapy (HCL)
n=12 Participants
Pregnant women with T1D with use an insulin pump and a continuous glucose monitor with automated insulin adjustments made by the system, but continued meal boluses from the women.
Hybrid closed-loop therapy: Hybrid closed-loop therapy with a proportional integral derivative (PID) algorithm
|
|---|---|---|
|
Secondary Indices of Glucose Control: Continuous Overall Net Glycemic Action (CONGAn)
CONGAn (Run-In Phase)
|
39.9 mg/dL
Standard Error 1.99
|
42.0 mg/dL
Standard Error 2.04
|
|
Secondary Indices of Glucose Control: Continuous Overall Net Glycemic Action (CONGAn)
CONGAn (1st Trimester)
|
41.3 mg/dL
Standard Error 1.99
|
44.3 mg/dL
Standard Error 2.04
|
|
Secondary Indices of Glucose Control: Continuous Overall Net Glycemic Action (CONGAn)
CONGAn (2nd Trimester)
|
36.4 mg/dL
Standard Error 1.99
|
40.1 mg/dL
Standard Error 2.04
|
|
Secondary Indices of Glucose Control: Continuous Overall Net Glycemic Action (CONGAn)
CONGAn (3rd Trimester)
|
29.6 mg/dL
Standard Error 1.99
|
35.2 mg/dL
Standard Error 2.04
|
|
Secondary Indices of Glucose Control: Continuous Overall Net Glycemic Action (CONGAn)
CONGAn (Post-Partum)
|
40.0 mg/dL
Standard Error 2.03
|
42.6 mg/dL
Standard Error 2.04
|
SECONDARY outcome
Timeframe: through study completion, an average of 9 monthsQuality of life as measured by scores from the MOS Short-Form 36 (quality of life) of HCL and SAPT arms in pregnant women with T1D. The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perceptions, Physical role functioning, Emotional role functioning, Social role functioning, Mental health
Outcome measures
| Measure |
Sensor-augmented Pump Therapy (SAPT)
n=12 Participants
Pregnant women with T1D with use an insulin pump and a continuous glucose monitor but there will be no automated insulin adjustments made by the system.
Sensor-augmented pump therapy: Insulin pump + non-communicating CGM
|
Hybrid Closed-loop Therapy (HCL)
n=12 Participants
Pregnant women with T1D with use an insulin pump and a continuous glucose monitor with automated insulin adjustments made by the system, but continued meal boluses from the women.
Hybrid closed-loop therapy: Hybrid closed-loop therapy with a proportional integral derivative (PID) algorithm
|
|---|---|---|
|
Medical Outcomes Study (MOS) Short-Form 36 Score
SF36 Emotional Wellbeing (3rd Trimester)
|
76.12 score on a scale
Standard Deviation 4.22
|
78.72 score on a scale
Standard Deviation 4.38
|
|
Medical Outcomes Study (MOS) Short-Form 36 Score
SF36 Emotional Wellbeing (Postpartum)
|
71.42 score on a scale
Standard Deviation 4.42
|
84.56 score on a scale
Standard Deviation 4.38
|
|
Medical Outcomes Study (MOS) Short-Form 36 Score
SF36 Energy (1st Trimester)
|
46.22 score on a scale
Standard Deviation 5.48
|
53.06 score on a scale
Standard Deviation 5.39
|
|
Medical Outcomes Study (MOS) Short-Form 36 Score
SF36 Energy (2nd Trimester)
|
51.04 score on a scale
Standard Deviation 5.99
|
57.29 score on a scale
Standard Deviation 6.32
|
|
Medical Outcomes Study (MOS) Short-Form 36 Score
SF36 Energy (3rd Trimester)
|
48.56 score on a scale
Standard Deviation 6.16
|
45.97 score on a scale
Standard Deviation 6.32
|
|
Medical Outcomes Study (MOS) Short-Form 36 Score
SF36 Energy (Postpartum)
|
40.95 score on a scale
Standard Deviation 6.40
|
53.76 score on a scale
Standard Deviation 6.33
|
|
Medical Outcomes Study (MOS) Short-Form 36 Score
SF36 Emotional Limits (1st Trimester)
|
81.98 score on a scale
Standard Deviation 7.33
|
95.74 score on a scale
Standard Deviation 7.20
|
|
Medical Outcomes Study (MOS) Short-Form 36 Score
SF36 Total (1st Trimester)
|
73.96 score on a scale
Standard Deviation 3.51
|
82.23 score on a scale
Standard Deviation 3.44
|
|
Medical Outcomes Study (MOS) Short-Form 36 Score
SF36 Total (2nd Trimester)
|
76.30 score on a scale
Standard Deviation 3.80
|
85.72 score on a scale
Standard Deviation 4.04
|
|
Medical Outcomes Study (MOS) Short-Form 36 Score
SF36 Total (3rd Trimester)
|
66.01 score on a scale
Standard Deviation 3.92
|
77.09 score on a scale
Standard Deviation 4.04
|
|
Medical Outcomes Study (MOS) Short-Form 36 Score
SF36 Total (Postpartum)
|
70.45 score on a scale
Standard Deviation 4.09
|
80.55 score on a scale
Standard Deviation 4.05
|
|
Medical Outcomes Study (MOS) Short-Form 36 Score
SF36 General Health (1st Trimester)
|
63.33 score on a scale
Standard Deviation 4.40
|
64.05 score on a scale
Standard Deviation 4.32
|
|
Medical Outcomes Study (MOS) Short-Form 36 Score
SF36 General Health (2nd Trimester)
|
62.61 score on a scale
Standard Deviation 4.60
|
67.77 score on a scale
Standard Deviation 4.69
|
|
Medical Outcomes Study (MOS) Short-Form 36 Score
SF36 General Health (3rd Trimester)
|
59.95 score on a scale
Standard Deviation 4.67
|
62.72 score on a scale
Standard Deviation 4.69
|
|
Medical Outcomes Study (MOS) Short-Form 36 Score
SF36 General Health (Postpartum)
|
64.70 score on a scale
Standard Deviation 4.77
|
65.45 score on a scale
Standard Deviation 4.69
|
|
Medical Outcomes Study (MOS) Short-Form 36 Score
SF36 Pain (1st Trimester)
|
81.33 score on a scale
Standard Deviation 4.68
|
90.66 score on a scale
Standard Deviation 4.62
|
|
Medical Outcomes Study (MOS) Short-Form 36 Score
SF36 Pain (2nd Trimester)
|
85.94 score on a scale
Standard Deviation 5.32
|
93.89 score on a scale
Standard Deviation 5.74
|
|
Medical Outcomes Study (MOS) Short-Form 36 Score
SF36 Pain (3rd Trimester)
|
63.37 score on a scale
Standard Deviation 5.52
|
80.78 score on a scale
Standard Deviation 5.75
|
|
Medical Outcomes Study (MOS) Short-Form 36 Score
SF36 Pain (Postpartum)
|
67.50 score on a scale
Standard Deviation 5.80
|
79.64 score on a scale
Standard Deviation 5.75
|
|
Medical Outcomes Study (MOS) Short-Form 36 Score
SF36 Social Functioning (1st Trimester)
|
85.99 score on a scale
Standard Deviation 3.89
|
90.36 score on a scale
Standard Deviation 3.86
|
|
Medical Outcomes Study (MOS) Short-Form 36 Score
SF36 Social Functioning (2nd Trimester)
|
81.62 score on a scale
Standard Deviation 4.54
|
95.31 score on a scale
Standard Deviation 4.96
|
|
Medical Outcomes Study (MOS) Short-Form 36 Score
SF36 Social Functioning (3rd Trimester)
|
82.28 score on a scale
Standard Deviation 4.74
|
89.83 score on a scale
Standard Deviation 4.96
|
|
Medical Outcomes Study (MOS) Short-Form 36 Score
SF36 Social Functioning (Postpartum)
|
82.14 score on a scale
Standard Deviation 5.00
|
91.26 score on a scale
Standard Deviation 4.97
|
|
Medical Outcomes Study (MOS) Short-Form 36 Score
SF36 Emotional Wellbeing (1st Trimester)
|
78.59 score on a scale
Standard Deviation 3.61
|
83.18 score on a scale
Standard Deviation 3.56
|
|
Medical Outcomes Study (MOS) Short-Form 36 Score
SF36 Emotional Wellbeing (2nd Trimester)
|
70.45 score on a scale
Standard Deviation 4.07
|
84.15 score on a scale
Standard Deviation 4.37
|
|
Medical Outcomes Study (MOS) Short-Form 36 Score
SF36 Emotional Limits (2nd Trimester)
|
84.70 score on a scale
Standard Deviation 8.01
|
98.44 score on a scale
Standard Deviation 8.55
|
|
Medical Outcomes Study (MOS) Short-Form 36 Score
SF36 Emotional Limits (3rd Trimester)
|
76.96 score on a scale
Standard Deviation 8.28
|
91.08 score on a scale
Standard Deviation 8.56
|
|
Medical Outcomes Study (MOS) Short-Form 36 Score
SF36 Emotional Limits (Postpartum)
|
84.51 score on a scale
Standard Deviation 8.65
|
98.00 score on a scale
Standard Deviation 8.57
|
|
Medical Outcomes Study (MOS) Short-Form 36 Score
SF36 Physical Health Limits (1st Trimester)
|
71.70 score on a scale
Standard Deviation 8.96
|
88.61 score on a scale
Standard Deviation 8.82
|
|
Medical Outcomes Study (MOS) Short-Form 36 Score
SF36 Physical Health Limits (2nd Trimester)
|
83.72 score on a scale
Standard Deviation 10.16
|
95.69 score on a scale
Standard Deviation 10.97
|
|
Medical Outcomes Study (MOS) Short-Form 36 Score
SF36 Physical Health Limits (3rd Trimester)
|
42.62 score on a scale
Standard Deviation 10.45
|
90.26 score on a scale
Standard Deviation 10.98
|
|
Medical Outcomes Study (MOS) Short-Form 36 Score
SF36 Physical Health Limits (Postpartum)
|
81.83 score on a scale
Standard Deviation 10.99
|
81.83 score on a scale
Standard Deviation 10.99
|
|
Medical Outcomes Study (MOS) Short-Form 36 Score
SF36 Physical Functioning (1st Trimester)
|
88.89 score on a scale
Standard Deviation 4.22
|
93.47 score on a scale
Standard Deviation 4.18
|
|
Medical Outcomes Study (MOS) Short-Form 36 Score
SF36 Physical Functioning (2nd Trimester)
|
91.52 score on a scale
Standard Deviation 4.86
|
93.31 score on a scale
Standard Deviation 5.28
|
|
Medical Outcomes Study (MOS) Short-Form 36 Score
SF36 Physical Functioning (3rd Trimester)
|
79.65 score on a scale
Standard Deviation 5.06
|
78.97 score on a scale
Standard Deviation 5.28
|
|
Medical Outcomes Study (MOS) Short-Form 36 Score
SF36 Physical Functioning (Postpartum)
|
84.69 score on a scale
Standard Deviation 5.32
|
92.15 score on a scale
Standard Deviation 5.29
|
SECONDARY outcome
Timeframe: through study completion, an average of 9 monthsPopulation: INSPIRE Questionnaire only among HCL randomized group
Quality of life as measured by scores from the INSPIRE questionnaire of HCL in pregnant women with T1D. The INsulin Dosing Systems: Perceptions, Ideas, Reflections, and Expectations (INSPIRE) is a survey consisting of 22 questions that assess user expectations and experiences with automated insulin delivery systems. Scores are calculated by determining the mean of the sum of all questions then multiplying the mean by 25 for a range of 0 to 100. Higher scores indicate more positive perceptions of the system. Each survey question uses a 5 point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree).
Outcome measures
| Measure |
Sensor-augmented Pump Therapy (SAPT)
n=12 Participants
Pregnant women with T1D with use an insulin pump and a continuous glucose monitor but there will be no automated insulin adjustments made by the system.
Sensor-augmented pump therapy: Insulin pump + non-communicating CGM
|
Hybrid Closed-loop Therapy (HCL)
Pregnant women with T1D with use an insulin pump and a continuous glucose monitor with automated insulin adjustments made by the system, but continued meal boluses from the women.
Hybrid closed-loop therapy: Hybrid closed-loop therapy with a proportional integral derivative (PID) algorithm
|
|---|---|---|
|
INSPIRE Questionnaire Score
Baseline/1st Trimester
|
73.6 score on a scale
Standard Deviation 4.1
|
—
|
|
INSPIRE Questionnaire Score
2nd Trimester
|
79.3 score on a scale
Standard Deviation 4.8
|
—
|
|
INSPIRE Questionnaire Score
3rd Trimester
|
76.2 score on a scale
Standard Deviation 4.6
|
—
|
|
INSPIRE Questionnaire Score
Post-Partum
|
76.5 score on a scale
Standard Deviation 4.8
|
—
|
SECONDARY outcome
Timeframe: through study completion, an average of 9 monthsDevice acceptability as measured by scores from the Insulin Delivery Satisfaction Survey of HCL and SAPT arms in pregnant women with T1D. The IDSS scale has a total score and 3 subscales: effective, burdensome, and inconvenient. Possible scores range from 1-5, with higher scores indicating higher satisfaction with insulin delivery system. Scores are reflective of the mean of the Total or subscale questions.
Outcome measures
| Measure |
Sensor-augmented Pump Therapy (SAPT)
n=12 Participants
Pregnant women with T1D with use an insulin pump and a continuous glucose monitor but there will be no automated insulin adjustments made by the system.
Sensor-augmented pump therapy: Insulin pump + non-communicating CGM
|
Hybrid Closed-loop Therapy (HCL)
n=12 Participants
Pregnant women with T1D with use an insulin pump and a continuous glucose monitor with automated insulin adjustments made by the system, but continued meal boluses from the women.
Hybrid closed-loop therapy: Hybrid closed-loop therapy with a proportional integral derivative (PID) algorithm
|
|---|---|---|
|
Insulin Delivery Satisfaction Survey (IDSS) Score
IDSS Total (1st Trimester)
|
4.00 score on a scale
Standard Deviation 0.14
|
4.06 score on a scale
Standard Deviation 0.14
|
|
Insulin Delivery Satisfaction Survey (IDSS) Score
IDSS Total (2nd Trimester)
|
3.80 score on a scale
Standard Deviation .015
|
4.19 score on a scale
Standard Deviation 0.16
|
|
Insulin Delivery Satisfaction Survey (IDSS) Score
IDSS Total (3rd Trimester)
|
3.85 score on a scale
Standard Deviation 0.16
|
3.92 score on a scale
Standard Deviation 0.16
|
|
Insulin Delivery Satisfaction Survey (IDSS) Score
IDSS Total (Postpartum)
|
3.92 score on a scale
Standard Deviation 0.16
|
4.20 score on a scale
Standard Deviation 0.16
|
|
Insulin Delivery Satisfaction Survey (IDSS) Score
IDSS Effective (1st Trimester)
|
4.12 score on a scale
Standard Deviation 0.15
|
4.16 score on a scale
Standard Deviation 0.15
|
|
Insulin Delivery Satisfaction Survey (IDSS) Score
IDSS Effective (2nd Trimester)
|
4.13 score on a scale
Standard Deviation 0.17
|
4.32 score on a scale
Standard Deviation 0.18
|
|
Insulin Delivery Satisfaction Survey (IDSS) Score
IDSS Effective (3rd Trimester)
|
4.26 score on a scale
Standard Deviation 0.17
|
4.16 score on a scale
Standard Deviation 0.18
|
|
Insulin Delivery Satisfaction Survey (IDSS) Score
IDSS Effective (Postpartum)
|
4.26 score on a scale
Standard Deviation 0.18
|
4.32 score on a scale
Standard Deviation 0.18
|
|
Insulin Delivery Satisfaction Survey (IDSS) Score
IDSS Burdensome (1st Trimester)
|
2.10 score on a scale
Standard Deviation 0.19
|
2.08 score on a scale
Standard Deviation 0.19
|
|
Insulin Delivery Satisfaction Survey (IDSS) Score
IDSS Burdensome (2nd Trimester)
|
2.46 score on a scale
Standard Deviation 0.21
|
2.04 score on a scale
Standard Deviation 0.22
|
|
Insulin Delivery Satisfaction Survey (IDSS) Score
IDSS Burdensome (3rd Trimester)
|
2.36 score on a scale
Standard Deviation 0.21
|
2.24 score on a scale
Standard Deviation 0.22
|
|
Insulin Delivery Satisfaction Survey (IDSS) Score
IDSS Burdensome (Postpartum)
|
2.41 score on a scale
Standard Deviation 0.22
|
2.06 score on a scale
Standard Deviation 0.22
|
|
Insulin Delivery Satisfaction Survey (IDSS) Score
IDSS Inconvenient (1st Trimester)
|
2.03 score on a scale
Standard Deviation 0.18
|
1.90 score on a scale
Standard Deviation 0.18
|
|
Insulin Delivery Satisfaction Survey (IDSS) Score
IDSS Inconvenient (2nd Trimester)
|
2.27 score on a scale
Standard Deviation 0.20
|
1.69 score on a scale
Standard Deviation 0.21
|
|
Insulin Delivery Satisfaction Survey (IDSS) Score
IDSS Inconvenient (3rd Trimester)
|
2.36 score on a scale
Standard Deviation 0.21
|
2.17 score on a scale
Standard Deviation 0.21
|
|
Insulin Delivery Satisfaction Survey (IDSS) Score
IDSS Inconvenient (Postpartum)
|
2.07 score on a scale
Standard Deviation 0.22
|
1.63 score on a scale
Standard Deviation 0.21
|
SECONDARY outcome
Timeframe: through study completion, an average of 9 monthsDevice acceptability as measured by scores from the Glucose Monitoring Satisfaction Survey questionnaires of HCL compared to SAPT in pregnancy women with T1D. The GMSS has a total score and 4 subscales: openness, emotional burden, behavioral burden, and trust. Possible scores range from 1-5, with higher total scores indicating greater satisfaction. Scores are reflective of the mean of the Total or subscale questions.
Outcome measures
| Measure |
Sensor-augmented Pump Therapy (SAPT)
n=12 Participants
Pregnant women with T1D with use an insulin pump and a continuous glucose monitor but there will be no automated insulin adjustments made by the system.
Sensor-augmented pump therapy: Insulin pump + non-communicating CGM
|
Hybrid Closed-loop Therapy (HCL)
n=12 Participants
Pregnant women with T1D with use an insulin pump and a continuous glucose monitor with automated insulin adjustments made by the system, but continued meal boluses from the women.
Hybrid closed-loop therapy: Hybrid closed-loop therapy with a proportional integral derivative (PID) algorithm
|
|---|---|---|
|
Glucose Monitoring Satisfaction Survey (GMSS) Score
GMSS Total (1st Trimester)
|
4.07 score on a scale
Standard Deviation 0.13
|
3.83 score on a scale
Standard Deviation 0.13
|
|
Glucose Monitoring Satisfaction Survey (GMSS) Score
GMSS Total (2nd Trimester)
|
3.65 score on a scale
Standard Deviation 0.15
|
4.06 score on a scale
Standard Deviation 0.16
|
|
Glucose Monitoring Satisfaction Survey (GMSS) Score
GMSS Total (3rd Trimester)
|
3.66 score on a scale
Standard Deviation 0.15
|
3.89 score on a scale
Standard Deviation 0.16
|
|
Glucose Monitoring Satisfaction Survey (GMSS) Score
GMSS Total (Postpartum)
|
3.90 score on a scale
Standard Deviation 0.16
|
3.95 score on a scale
Standard Deviation 0.16
|
|
Glucose Monitoring Satisfaction Survey (GMSS) Score
GMSS Trust (1st Trimester)
|
3.99 score on a scale
Standard Deviation 0.19
|
3.65 score on a scale
Standard Deviation 0.20
|
|
Glucose Monitoring Satisfaction Survey (GMSS) Score
GMSS Trust (2nd Trimester)
|
3.43 score on a scale
Standard Deviation 0.22
|
4.10 score on a scale
Standard Deviation 0.24
|
|
Glucose Monitoring Satisfaction Survey (GMSS) Score
GMSS Trust (3rd Trimester)
|
3.75 score on a scale
Standard Deviation 0.23
|
4.10 score on a scale
Standard Deviation 0.24
|
|
Glucose Monitoring Satisfaction Survey (GMSS) Score
GMSS Trust (Postpartum)
|
3.76 score on a scale
Standard Deviation 0.24
|
3.77 score on a scale
Standard Deviation 0.24
|
|
Glucose Monitoring Satisfaction Survey (GMSS) Score
GMSS Behavioral Burden (1st Trimester)
|
1.86 score on a scale
Standard Deviation 0.15
|
2.01 score on a scale
Standard Deviation 0.15
|
|
Glucose Monitoring Satisfaction Survey (GMSS) Score
GMSS Behavioral Burden (2nd Trimester)
|
2.07 score on a scale
Standard Deviation 0.17
|
1.78 score on a scale
Standard Deviation 0.18
|
|
Glucose Monitoring Satisfaction Survey (GMSS) Score
GMSS Behavioral Burden (3rd Trimester)
|
2.29 score on a scale
Standard Deviation 0.17
|
1.99 score on a scale
Standard Deviation 0.18
|
|
Glucose Monitoring Satisfaction Survey (GMSS) Score
GMSS Behavioral Burden (Postpartum)
|
1.99 score on a scale
Standard Deviation 0.18
|
1.97 score on a scale
Standard Deviation 0.18
|
|
Glucose Monitoring Satisfaction Survey (GMSS) Score
GMSS Emotional Burden (1st Trimester)
|
1.83 score on a scale
Standard Deviation 0.19
|
2.11 score on a scale
Standard Deviation 0.19
|
|
Glucose Monitoring Satisfaction Survey (GMSS) Score
GMSS Emotional Burden (2nd Trimester)
|
2.41 score on a scale
Standard Deviation 0.21
|
1.85 score on a scale
Standard Deviation 0.22
|
|
Glucose Monitoring Satisfaction Survey (GMSS) Score
GMSS Emotional Burden (3rd Trimester)
|
2.34 score on a scale
Standard Deviation 0.22
|
1.92 score on a scale
Standard Deviation 0.22
|
|
Glucose Monitoring Satisfaction Survey (GMSS) Score
GMSS Emotional Burden (Postpartum)
|
2.06 score on a scale
Standard Deviation 0.23
|
2.02 score on a scale
Standard Deviation 0.23
|
|
Glucose Monitoring Satisfaction Survey (GMSS) Score
GMSS Openness (1st Trimester)
|
3.95 score on a scale
Standard Deviation 0.14
|
3.74 score on a scale
Standard Deviation 0.14
|
|
Glucose Monitoring Satisfaction Survey (GMSS) Score
GMSS Openness (2nd Trimester)
|
3.58 score on a scale
Standard Deviation 0.16
|
3.76 score on a scale
Standard Deviation 0.18
|
|
Glucose Monitoring Satisfaction Survey (GMSS) Score
GMSS Openness (3rd Trimester)
|
3.55 score on a scale
Standard Deviation 0.17
|
3.43 score on a scale
Standard Deviation 0.18
|
|
Glucose Monitoring Satisfaction Survey (GMSS) Score
GMSS Openness (Postpartum)
|
3.86 score on a scale
Standard Deviation 0.18
|
3.97 score on a scale
Standard Deviation 0.18
|
SECONDARY outcome
Timeframe: through study completion, an average of 9 monthsMaternal outcomes includes preeclampsia/eclampsia in pregnant women with T1D using HCL therapy compared to those using SAPT throughout gestation and in the early post-partum period
Outcome measures
| Measure |
Sensor-augmented Pump Therapy (SAPT)
n=12 Participants
Pregnant women with T1D with use an insulin pump and a continuous glucose monitor but there will be no automated insulin adjustments made by the system.
Sensor-augmented pump therapy: Insulin pump + non-communicating CGM
|
Hybrid Closed-loop Therapy (HCL)
n=11 Participants
Pregnant women with T1D with use an insulin pump and a continuous glucose monitor with automated insulin adjustments made by the system, but continued meal boluses from the women.
Hybrid closed-loop therapy: Hybrid closed-loop therapy with a proportional integral derivative (PID) algorithm
|
|---|---|---|
|
Maternal Outcomes: Number of Participants With Preeclampsia/Eclampsia
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: through study completion, an average of 9 monthsMaternal outcomes includes cesarean delivery in pregnant women with T1D using HCL therapy compared to those using SAPT throughout gestation and in the early post-partum period
Outcome measures
| Measure |
Sensor-augmented Pump Therapy (SAPT)
n=12 Participants
Pregnant women with T1D with use an insulin pump and a continuous glucose monitor but there will be no automated insulin adjustments made by the system.
Sensor-augmented pump therapy: Insulin pump + non-communicating CGM
|
Hybrid Closed-loop Therapy (HCL)
n=11 Participants
Pregnant women with T1D with use an insulin pump and a continuous glucose monitor with automated insulin adjustments made by the system, but continued meal boluses from the women.
Hybrid closed-loop therapy: Hybrid closed-loop therapy with a proportional integral derivative (PID) algorithm
|
|---|---|---|
|
Maternal Outcomes: Number of Participants With Cesarean Delivery
|
10 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: through study completion, an average of 9 monthsMaternal outcomes includes gestational weight gain in pregnant women with T1D using HCL therapy compared to those using SAPT throughout gestation and in the early post-partum period
Outcome measures
| Measure |
Sensor-augmented Pump Therapy (SAPT)
n=12 Participants
Pregnant women with T1D with use an insulin pump and a continuous glucose monitor but there will be no automated insulin adjustments made by the system.
Sensor-augmented pump therapy: Insulin pump + non-communicating CGM
|
Hybrid Closed-loop Therapy (HCL)
n=11 Participants
Pregnant women with T1D with use an insulin pump and a continuous glucose monitor with automated insulin adjustments made by the system, but continued meal boluses from the women.
Hybrid closed-loop therapy: Hybrid closed-loop therapy with a proportional integral derivative (PID) algorithm
|
|---|---|---|
|
Maternal Outcomes: Average Gestational Weight Gain
|
14.1 kg
Standard Deviation 6.0
|
11.5 kg
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: through study completion, an average of 9 monthsFetal outcomes includes fetal loss (miscarriage or stillbirth) in pregnant women with T1D using HCL therapy compared to those using SAPT throughout gestation and in the early post-partum period
Outcome measures
| Measure |
Sensor-augmented Pump Therapy (SAPT)
n=12 Participants
Pregnant women with T1D with use an insulin pump and a continuous glucose monitor but there will be no automated insulin adjustments made by the system.
Sensor-augmented pump therapy: Insulin pump + non-communicating CGM
|
Hybrid Closed-loop Therapy (HCL)
n=11 Participants
Pregnant women with T1D with use an insulin pump and a continuous glucose monitor with automated insulin adjustments made by the system, but continued meal boluses from the women.
Hybrid closed-loop therapy: Hybrid closed-loop therapy with a proportional integral derivative (PID) algorithm
|
|---|---|---|
|
Fetal Outcomes: Number of Participants With a Fetal Loss (Miscarriage or Stillbirth)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: through study completion, an average of 9 monthsFetal outcomes includes large-for-gestational age in pregnant women with T1D using HCL therapy compared to those using SAPT throughout gestation and in the early post-partum period
Outcome measures
| Measure |
Sensor-augmented Pump Therapy (SAPT)
n=12 Participants
Pregnant women with T1D with use an insulin pump and a continuous glucose monitor but there will be no automated insulin adjustments made by the system.
Sensor-augmented pump therapy: Insulin pump + non-communicating CGM
|
Hybrid Closed-loop Therapy (HCL)
n=11 Participants
Pregnant women with T1D with use an insulin pump and a continuous glucose monitor with automated insulin adjustments made by the system, but continued meal boluses from the women.
Hybrid closed-loop therapy: Hybrid closed-loop therapy with a proportional integral derivative (PID) algorithm
|
|---|---|---|
|
Fetal Outcomes: Number of Infants With Large-for-gestational Age Outcome
|
6 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: through study completion, an average of 9 monthsFetal outcomes includes neonatal hypoglycemia in pregnant women with T1D using HCL therapy compared to those using SAPT throughout gestation and in the early post-partum period
Outcome measures
| Measure |
Sensor-augmented Pump Therapy (SAPT)
n=12 Participants
Pregnant women with T1D with use an insulin pump and a continuous glucose monitor but there will be no automated insulin adjustments made by the system.
Sensor-augmented pump therapy: Insulin pump + non-communicating CGM
|
Hybrid Closed-loop Therapy (HCL)
n=11 Participants
Pregnant women with T1D with use an insulin pump and a continuous glucose monitor with automated insulin adjustments made by the system, but continued meal boluses from the women.
Hybrid closed-loop therapy: Hybrid closed-loop therapy with a proportional integral derivative (PID) algorithm
|
|---|---|---|
|
Fetal Outcomes: Number of Participants With Neonatal Hypoglycemia Infants
|
4 Participants
|
5 Participants
|
Adverse Events
Sensor-augmented Pump Therapy (SAPT)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Hybrid Closed-loop Therapy (HCL)
Serious events: 6 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sensor-augmented Pump Therapy (SAPT)
n=12 participants at risk
Pregnant women with T1D with use an insulin pump and a continuous glucose monitor but there will be no automated insulin adjustments made by the system.
Sensor-augmented pump therapy: Insulin pump + non-communicating CGM
|
Hybrid Closed-loop Therapy (HCL)
n=12 participants at risk
Pregnant women with T1D with use an insulin pump and a continuous glucose monitor with automated insulin adjustments made by the system, but continued meal boluses from the women.
Hybrid closed-loop therapy: Hybrid closed-loop therapy with a proportional integral derivative (PID) algorithm
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Fetal Demise
|
0.00%
0/12 • through study completion, an average of 9 months
|
8.3%
1/12 • Number of events 1 • through study completion, an average of 9 months
|
|
Endocrine disorders
DKA
|
0.00%
0/12 • through study completion, an average of 9 months
|
8.3%
1/12 • Number of events 1 • through study completion, an average of 9 months
|
|
Endocrine disorders
Severe Hypoglycemia
|
0.00%
0/12 • through study completion, an average of 9 months
|
8.3%
1/12 • Number of events 1 • through study completion, an average of 9 months
|
|
Cardiac disorders
Preeclampsia with Severe Features
|
0.00%
0/12 • through study completion, an average of 9 months
|
16.7%
2/12 • Number of events 2 • through study completion, an average of 9 months
|
|
Cardiac disorders
Chronic Hypertension with Superimpose Preeclampsia with Severe Features
|
0.00%
0/12 • through study completion, an average of 9 months
|
8.3%
1/12 • Number of events 1 • through study completion, an average of 9 months
|
Other adverse events
| Measure |
Sensor-augmented Pump Therapy (SAPT)
n=12 participants at risk
Pregnant women with T1D with use an insulin pump and a continuous glucose monitor but there will be no automated insulin adjustments made by the system.
Sensor-augmented pump therapy: Insulin pump + non-communicating CGM
|
Hybrid Closed-loop Therapy (HCL)
n=12 participants at risk
Pregnant women with T1D with use an insulin pump and a continuous glucose monitor with automated insulin adjustments made by the system, but continued meal boluses from the women.
Hybrid closed-loop therapy: Hybrid closed-loop therapy with a proportional integral derivative (PID) algorithm
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Miscarriage
|
16.7%
2/12 • through study completion, an average of 9 months
|
0.00%
0/12 • through study completion, an average of 9 months
|
|
Pregnancy, puerperium and perinatal conditions
Polyhydramnios
|
16.7%
2/12 • Number of events 3 • through study completion, an average of 9 months
|
16.7%
2/12 • Number of events 2 • through study completion, an average of 9 months
|
|
Pregnancy, puerperium and perinatal conditions
Preterm Birth
|
16.7%
2/12 • Number of events 2 • through study completion, an average of 9 months
|
16.7%
2/12 • Number of events 2 • through study completion, an average of 9 months
|
|
Endocrine disorders
Hyperglycemia
|
8.3%
1/12 • Number of events 1 • through study completion, an average of 9 months
|
25.0%
3/12 • Number of events 4 • through study completion, an average of 9 months
|
|
Endocrine disorders
Ketonuria
|
25.0%
3/12 • Number of events 3 • through study completion, an average of 9 months
|
8.3%
1/12 • Number of events 1 • through study completion, an average of 9 months
|
|
Endocrine disorders
Hypoglycemia
|
0.00%
0/12 • through study completion, an average of 9 months
|
16.7%
2/12 • through study completion, an average of 9 months
|
|
Cardiac disorders
Gestational Hypertension
|
25.0%
3/12 • through study completion, an average of 9 months
|
8.3%
1/12 • through study completion, an average of 9 months
|
|
Cardiac disorders
Preeclampsia without Severe Features
|
8.3%
1/12 • through study completion, an average of 9 months
|
8.3%
1/12 • through study completion, an average of 9 months
|
|
Infections and infestations
Illness
|
41.7%
5/12 • through study completion, an average of 9 months
|
16.7%
2/12 • through study completion, an average of 9 months
|
|
Product Issues
Sensor Site Irritation
|
41.7%
5/12 • through study completion, an average of 9 months
|
8.3%
1/12 • through study completion, an average of 9 months
|
|
Psychiatric disorders
Post-Partum Depression/Anxiety
|
0.00%
0/12 • through study completion, an average of 9 months
|
9.1%
1/11 • through study completion, an average of 9 months
|
|
Blood and lymphatic system disorders
Anemia
|
8.3%
1/12 • through study completion, an average of 9 months
|
0.00%
0/12 • through study completion, an average of 9 months
|
|
Metabolism and nutrition disorders
Hypothyroidism
|
8.3%
1/12 • Number of events 1 • through study completion, an average of 9 months
|
0.00%
0/12 • through study completion, an average of 9 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal or Back Pain
|
8.3%
1/12 • Number of events 1 • through study completion, an average of 9 months
|
16.7%
2/12 • Number of events 2 • through study completion, an average of 9 months
|
|
General disorders
Headache/Migraine
|
8.3%
1/12 • Number of events 1 • through study completion, an average of 9 months
|
25.0%
3/12 • Number of events 4 • through study completion, an average of 9 months
|
|
Reproductive system and breast disorders
Ovarian Cyst
|
8.3%
1/12 • through study completion, an average of 9 months
|
0.00%
0/12 • through study completion, an average of 9 months
|
|
Pregnancy, puerperium and perinatal conditions
Nausea/Vomiting
|
0.00%
0/12 • through study completion, an average of 9 months
|
33.3%
4/12 • through study completion, an average of 9 months
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
8.3%
1/12 • through study completion, an average of 9 months
|
8.3%
1/12 • through study completion, an average of 9 months
|
|
General disorders
Large for Gestational Age Infant
|
16.7%
2/12 • through study completion, an average of 9 months
|
9.1%
1/11 • through study completion, an average of 9 months
|
|
Reproductive system and breast disorders
Yeast Infection
|
0.00%
0/12 • through study completion, an average of 9 months
|
8.3%
1/12 • Number of events 2 • through study completion, an average of 9 months
|
|
General disorders
Tenosynovitis
|
8.3%
1/12 • through study completion, an average of 9 months
|
0.00%
0/12 • through study completion, an average of 9 months
|
|
Reproductive system and breast disorders
Mastitis
|
8.3%
1/12 • Number of events 2 • through study completion, an average of 9 months
|
8.3%
1/12 • Number of events 1 • through study completion, an average of 9 months
|
|
General disorders
Neonatal Hypoglycemia
|
0.00%
0/12 • through study completion, an average of 9 months
|
9.1%
1/11 • through study completion, an average of 9 months
|
|
Immune system disorders
Seasonal Allergies
|
8.3%
1/12 • Number of events 2 • through study completion, an average of 9 months
|
0.00%
0/12 • through study completion, an average of 9 months
|
|
Reproductive system and breast disorders
Vaginal Aching
|
0.00%
0/12 • through study completion, an average of 9 months
|
8.3%
1/12 • through study completion, an average of 9 months
|
|
General disorders
Infant Respiratory Distress
|
16.7%
2/12 • through study completion, an average of 9 months
|
18.2%
2/11 • through study completion, an average of 9 months
|
|
General disorders
Abdominal Pain
|
16.7%
2/12 • through study completion, an average of 9 months
|
0.00%
0/12 • through study completion, an average of 9 months
|
|
Pregnancy, puerperium and perinatal conditions
Post-Partum Pain
|
0.00%
0/12 • through study completion, an average of 9 months
|
9.1%
1/11 • through study completion, an average of 9 months
|
|
General disorders
Pelvic Pain
|
0.00%
0/12 • through study completion, an average of 9 months
|
8.3%
1/12 • through study completion, an average of 9 months
|
|
Cardiac disorders
Mild Post-Partum Hypertension
|
8.3%
1/12 • through study completion, an average of 9 months
|
0.00%
0/12 • through study completion, an average of 9 months
|
|
Gastrointestinal disorders
Food Poisoning
|
0.00%
0/12 • through study completion, an average of 9 months
|
8.3%
1/12 • through study completion, an average of 9 months
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/12 • through study completion, an average of 9 months
|
8.3%
1/12 • through study completion, an average of 9 months
|
|
General disorders
Ankle/Feet Swelling
|
8.3%
1/12 • through study completion, an average of 9 months
|
16.7%
2/12 • through study completion, an average of 9 months
|
|
Nervous system disorders
Carpal Tunnel
|
8.3%
1/12 • through study completion, an average of 9 months
|
0.00%
0/12 • through study completion, an average of 9 months
|
|
General disorders
Foot Pain
|
8.3%
1/12 • through study completion, an average of 9 months
|
0.00%
0/12 • through study completion, an average of 9 months
|
|
Pregnancy, puerperium and perinatal conditions
Placental Hemorrhage
|
0.00%
0/12 • through study completion, an average of 9 months
|
8.3%
1/12 • through study completion, an average of 9 months
|
|
Cardiac disorders
Fetal Arrhythmia
|
8.3%
1/12 • through study completion, an average of 9 months
|
0.00%
0/12 • through study completion, an average of 9 months
|
|
Cardiac disorders
Fetal Bradycardia
|
8.3%
1/12 • through study completion, an average of 9 months
|
0.00%
0/12 • through study completion, an average of 9 months
|
|
Endocrine disorders
Blood Ketones
|
8.3%
1/12 • through study completion, an average of 9 months
|
0.00%
0/12 • through study completion, an average of 9 months
|
|
Pregnancy, puerperium and perinatal conditions
Increased Fetal Movement
|
8.3%
1/12 • through study completion, an average of 9 months
|
0.00%
0/12 • through study completion, an average of 9 months
|
|
Gastrointestinal disorders
Infant Gastroesophageal Reflux Disease
|
8.3%
1/12 • through study completion, an average of 9 months
|
0.00%
0/12 • through study completion, an average of 9 months
|
|
General disorders
Infant Laryngomalacia/ Supraglottic Edema
|
8.3%
1/12 • through study completion, an average of 9 months
|
0.00%
0/12 • through study completion, an average of 9 months
|
|
Reproductive system and breast disorders
Short Cervix
|
8.3%
1/12 • through study completion, an average of 9 months
|
0.00%
0/12 • through study completion, an average of 9 months
|
|
Musculoskeletal and connective tissue disorders
Hip Soreness
|
8.3%
1/12 • through study completion, an average of 9 months
|
0.00%
0/12 • through study completion, an average of 9 months
|
|
General disorders
Leg Bruising
|
8.3%
1/12 • through study completion, an average of 9 months
|
0.00%
0/12 • through study completion, an average of 9 months
|
|
Reproductive system and breast disorders
Vaginal Bleeding
|
0.00%
0/12 • through study completion, an average of 9 months
|
8.3%
1/12 • through study completion, an average of 9 months
|
|
Cardiac disorders
Elevated Blood Pressure (Mild)
|
0.00%
0/12 • through study completion, an average of 9 months
|
8.3%
1/12 • through study completion, an average of 9 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/12 • through study completion, an average of 9 months
|
8.3%
1/12 • through study completion, an average of 9 months
|
|
General disorders
Infant Shoulder Dystocia
|
0.00%
0/12 • through study completion, an average of 9 months
|
8.3%
1/12 • through study completion, an average of 9 months
|
|
Immune system disorders
Hives
|
0.00%
0/12 • through study completion, an average of 9 months
|
8.3%
1/12 • through study completion, an average of 9 months
|
|
General disorders
Finger Wart
|
0.00%
0/12 • through study completion, an average of 9 months
|
8.3%
1/12 • through study completion, an average of 9 months
|
|
General disorders
Abnormal Ultrasound Findings
|
0.00%
0/12 • through study completion, an average of 9 months
|
8.3%
1/12 • through study completion, an average of 9 months
|
|
Eye disorders
Scratched Cornea
|
0.00%
0/12 • through study completion, an average of 9 months
|
8.3%
1/12 • through study completion, an average of 9 months
|
|
Skin and subcutaneous tissue disorders
Eczema Flare-Up
|
0.00%
0/12 • through study completion, an average of 9 months
|
8.3%
1/12 • through study completion, an average of 9 months
|
|
General disorders
Non-Reassuring Fetal Wellbeing
|
0.00%
0/12 • through study completion, an average of 9 months
|
8.3%
1/12 • through study completion, an average of 9 months
|
Additional Information
Dr. Sarit Polsky
Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus
Phone: 303-724-8575
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place