Trial Outcomes & Findings for Initiation of Continuous Glucose Monitoring at Diagnosis of Type 1 Diabetes (NCT NCT02734667)
NCT ID: NCT02734667
Last Updated: 2022-03-02
Results Overview
Increasingly it is recognized that the percent time spent in a target blood glucose range, which is set by the American Diabetes Association, is an important outcome. This measure will be used as a primary outcome and derived from objective data downloads. It is calculated using the values for 14 days around the assessment time point.
COMPLETED
NA
120 participants
Collected entire period for 6 months post-baseline; primary endpoint is 14 day period around that 6-month time point
2022-03-02
Participant Flow
Both youth and parent were enrolled; parents were enrolled for assessments of surveys only, youth under 11 years of age did not complete surveys.
Participant milestones
| Measure |
CGM at Diagnosis of T1D
Participants start non-adjunctive use of continuous glucose monitoring (CGM) at diagnosis of type 1 diabetes (T1D) and continue for 6 months.
CGM at diagnosis of T1D: Initiation of non-adjunctive CGM use at diagnosis of T1D
Both groups followed through for up to 24 months
|
Usual Care
Participants receive usual care for T1D for 6 months post diagnosis.
Both groups followed through for up to 24 months
|
|---|---|---|
|
Overall Study
STARTED
|
84
|
36
|
|
Overall Study
Youth
|
42
|
18
|
|
Overall Study
Parent
|
42
|
18
|
|
Overall Study
COMPLETED
|
82
|
30
|
|
Overall Study
NOT COMPLETED
|
2
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Initiation of Continuous Glucose Monitoring at Diagnosis of Type 1 Diabetes
Baseline characteristics by cohort
| Measure |
CGM at Diagnosis of T1D
n=42 Participants
Participants start non-adjunctive use of CGM at diagnosis of T1D and continue for 6 months.
CGM at diagnosis of T1D: Initiation of non-adjunctive CGM use at diagnosis of T1D
Both groups followed through for up to 24 months
|
Usual Care
n=18 Participants
Participants receive usual care for T1D for 6 months post diagnosis.
Both groups followed through for up to 24 months
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
42 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
11.23 years
STANDARD_DEVIATION 3.58 • n=5 Participants
|
10.30 years
STANDARD_DEVIATION 3.51 • n=7 Participants
|
10.95 years
STANDARD_DEVIATION 3.56 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
42 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Collected entire period for 6 months post-baseline; primary endpoint is 14 day period around that 6-month time pointPopulation: This outcome was assessed in youths only.
Increasingly it is recognized that the percent time spent in a target blood glucose range, which is set by the American Diabetes Association, is an important outcome. This measure will be used as a primary outcome and derived from objective data downloads. It is calculated using the values for 14 days around the assessment time point.
Outcome measures
| Measure |
CGM at Diagnosis of T1D
n=42 Participants
Participants start non-adjunctive use of CGM at diagnosis of T1D and continue for 6 months.
CGM at diagnosis of T1D: Initiation of non-adjunctive CGM use at diagnosis of T1D
Both groups followed through for up to 24 months
|
Usual Care
n=18 Participants
Participants receive usual care for T1D for 6 months post diagnosis.
Both groups followed through for up to 24 months
|
|---|---|---|
|
Time Spent in Blood Glucose Range (70-180mg/dL)
|
64.99 percentage of time
Standard Deviation 18.39
|
62.54 percentage of time
Standard Deviation 19.10
|
PRIMARY outcome
Timeframe: Baseline, 24 monthsPopulation: Participants with complete data (by youth and parent) are included in the analysis.
The GMSS is a validated survey created to measure the level of satisfaction a person with diabetes - type 1 or type 2 - experiences in response to monitoring glucose values. It was validated in people using CGM. Scores range 0 to 5 with higher scores indicating greater satisfaction.
Outcome measures
| Measure |
CGM at Diagnosis of T1D
n=49 Participants
Participants start non-adjunctive use of CGM at diagnosis of T1D and continue for 6 months.
CGM at diagnosis of T1D: Initiation of non-adjunctive CGM use at diagnosis of T1D
Both groups followed through for up to 24 months
|
Usual Care
n=21 Participants
Participants receive usual care for T1D for 6 months post diagnosis.
Both groups followed through for up to 24 months
|
|---|---|---|
|
Glucose Monitoring Satisfaction Survey (GMSS) - Parent
Youth - baseline
|
3.52 score on a scale
Standard Deviation 0.50
|
3.54 score on a scale
Standard Deviation 0.27
|
|
Glucose Monitoring Satisfaction Survey (GMSS) - Parent
Youth - 24 months
|
3.76 score on a scale
Standard Deviation 0.6
|
3.82 score on a scale
Standard Deviation 0.54
|
|
Glucose Monitoring Satisfaction Survey (GMSS) - Parent
Parent - baseline
|
3.65 score on a scale
Standard Deviation 0.59
|
3.28 score on a scale
Standard Deviation 0.68
|
|
Glucose Monitoring Satisfaction Survey (GMSS) - Parent
Parent - 24 months
|
3.91 score on a scale
Standard Deviation 0.66
|
3.75 score on a scale
Standard Deviation 0.77
|
PRIMARY outcome
Timeframe: Collected entire period for 6 months post-baseline; primary endpoint is 14 day period around that 6-month time pointPopulation: This outcome was assessed in youths only.
Time spent in hypoglycemia is calculated using the values for 14 days around the assessment time point.
Outcome measures
| Measure |
CGM at Diagnosis of T1D
n=42 Participants
Participants start non-adjunctive use of CGM at diagnosis of T1D and continue for 6 months.
CGM at diagnosis of T1D: Initiation of non-adjunctive CGM use at diagnosis of T1D
Both groups followed through for up to 24 months
|
Usual Care
n=18 Participants
Participants receive usual care for T1D for 6 months post diagnosis.
Both groups followed through for up to 24 months
|
|---|---|---|
|
Time Spent in Hypoglycemia (< 70 mg/dL)
|
1.87 percentage of time
Standard Deviation 1.65
|
5.06 percentage of time
Standard Deviation 5.13
|
SECONDARY outcome
Timeframe: Baseline, 24 monthsPopulation: Participants with complete data (by youth and parent) are included in the analysis.
This is a measure of health-related quality of life. It is used to understand the broader impact on quality of life which includes social, psychological, and health aspects of daily living. Scores range from 0 to 100. Higher scores indicate greater quality of life.
Outcome measures
| Measure |
CGM at Diagnosis of T1D
n=49 Participants
Participants start non-adjunctive use of CGM at diagnosis of T1D and continue for 6 months.
CGM at diagnosis of T1D: Initiation of non-adjunctive CGM use at diagnosis of T1D
Both groups followed through for up to 24 months
|
Usual Care
n=21 Participants
Participants receive usual care for T1D for 6 months post diagnosis.
Both groups followed through for up to 24 months
|
|---|---|---|
|
Pediatric Quality of Life Inventory
Youth - baseline
|
75.38 score on a scale
Standard Deviation 13.48
|
85.23 score on a scale
Standard Deviation 8.25
|
|
Pediatric Quality of Life Inventory
Youth - 24 months
|
82.67 score on a scale
Standard Deviation 14.49
|
92.08 score on a scale
Standard Deviation 10.31
|
|
Pediatric Quality of Life Inventory
Parent - baseline
|
75.27 score on a scale
Standard Deviation 14.79
|
81.05 score on a scale
Standard Deviation 12.26
|
|
Pediatric Quality of Life Inventory
Parent - 24 months
|
81.23 score on a scale
Standard Deviation 18.89
|
87.89 score on a scale
Standard Deviation 11.62
|
SECONDARY outcome
Timeframe: Baseline, 24 monthsPopulation: Participants with complete data (by youth and parent) are included in the analysis.
Participants in the study report on daily problems with diabetes via this measure. Respondents indicate the degree to which each of the items is currently a problem for them. Score range: 0 to 4, higher scores correspond to more serious problems.
Outcome measures
| Measure |
CGM at Diagnosis of T1D
n=49 Participants
Participants start non-adjunctive use of CGM at diagnosis of T1D and continue for 6 months.
CGM at diagnosis of T1D: Initiation of non-adjunctive CGM use at diagnosis of T1D
Both groups followed through for up to 24 months
|
Usual Care
n=21 Participants
Participants receive usual care for T1D for 6 months post diagnosis.
Both groups followed through for up to 24 months
|
|---|---|---|
|
Problem Areas in Diabetes Score
Parent - baseline
|
1.84 score on a scale
Standard Deviation 0.73
|
2.11 score on a scale
Standard Deviation 0.75
|
|
Problem Areas in Diabetes Score
Parent - 24 months
|
1.68 score on a scale
Standard Deviation 0.75
|
1.74 score on a scale
Standard Deviation 0.79
|
|
Problem Areas in Diabetes Score
Youth - baseline
|
1.02 score on a scale
Standard Deviation 0.72
|
0.78 score on a scale
Standard Deviation 0.48
|
|
Problem Areas in Diabetes Score
Youth - 24 months
|
0.77 score on a scale
Standard Deviation 0.81
|
0.43 score on a scale
Standard Deviation 0.44
|
SECONDARY outcome
Timeframe: Baseline, 24 monthsPopulation: Participants with complete data (by youth and parent) are included in the analysis.
This measure is widely used to capture the psychological distress experienced in relation to diabetes. Parent scale score range: 0-4. Youth scale score range: 1-6. Higher scores indicate greater diabetes-related distress.
Outcome measures
| Measure |
CGM at Diagnosis of T1D
n=49 Participants
Participants start non-adjunctive use of CGM at diagnosis of T1D and continue for 6 months.
CGM at diagnosis of T1D: Initiation of non-adjunctive CGM use at diagnosis of T1D
Both groups followed through for up to 24 months
|
Usual Care
n=21 Participants
Participants receive usual care for T1D for 6 months post diagnosis.
Both groups followed through for up to 24 months
|
|---|---|---|
|
Diabetes Distress Scale
Youth - baseline
|
1.87 score on a scale
Standard Deviation 0.65
|
1.85 score on a scale
Standard Deviation 0.67
|
|
Diabetes Distress Scale
Youth - 24 months
|
1.85 score on a scale
Standard Deviation 0.83
|
1.52 score on a scale
Standard Deviation 0.46
|
|
Diabetes Distress Scale
Parent - baseline
|
1.19 score on a scale
Standard Deviation 0.7
|
1.3 score on a scale
Standard Deviation 0.6
|
|
Diabetes Distress Scale
Parent - 24 months
|
1.32 score on a scale
Standard Deviation 0.96
|
1.32 score on a scale
Standard Deviation 1.05
|
SECONDARY outcome
Timeframe: Baseline, 24 monthsPopulation: Parent participants with complete data are included in the analysis. Youth did not complete this measure.
This is a widely used measure that captures depressive symptoms, and was used to assess health symptoms in parents. Score range: 0-24. Higher scores indicate greater severity of symptoms.
Outcome measures
| Measure |
CGM at Diagnosis of T1D
n=32 Participants
Participants start non-adjunctive use of CGM at diagnosis of T1D and continue for 6 months.
CGM at diagnosis of T1D: Initiation of non-adjunctive CGM use at diagnosis of T1D
Both groups followed through for up to 24 months
|
Usual Care
n=14 Participants
Participants receive usual care for T1D for 6 months post diagnosis.
Both groups followed through for up to 24 months
|
|---|---|---|
|
Patient Health Questionnaire 9
Parent - baseline
|
6.22 score on a scale
Standard Deviation 5.52
|
9.22 score on a scale
Standard Deviation 7.41
|
|
Patient Health Questionnaire 9
Parent - month 24
|
4.53 score on a scale
Standard Deviation 4.53
|
3.71 score on a scale
Standard Deviation 5.06
|
SECONDARY outcome
Timeframe: Baseline, 24 monthsPopulation: Parent participants with complete data are included in the analysis. Youth did not complete this measure.
This is a widely used measure of anxiety symptoms, and was used to assess anxiety symptoms in parents. Score range for both state-anxiety is: 20-80. Higher scores indicate greater anxiety.
Outcome measures
| Measure |
CGM at Diagnosis of T1D
n=32 Participants
Participants start non-adjunctive use of CGM at diagnosis of T1D and continue for 6 months.
CGM at diagnosis of T1D: Initiation of non-adjunctive CGM use at diagnosis of T1D
Both groups followed through for up to 24 months
|
Usual Care
n=14 Participants
Participants receive usual care for T1D for 6 months post diagnosis.
Both groups followed through for up to 24 months
|
|---|---|---|
|
State-Trait Anxiety Inventory
Parent - baseline state-anxiety
|
44.34 score on a scale
Standard Deviation 11.84
|
49.71 score on a scale
Standard Deviation 17
|
|
State-Trait Anxiety Inventory
Parent - 24 months state-anxiety
|
39.39 score on a scale
Standard Deviation 14.87
|
34.05 score on a scale
Standard Deviation 11.56
|
SECONDARY outcome
Timeframe: Baseline, 24 monthsPopulation: Parent participants with complete data are included in the analysis. Youth did not complete this measure.
This questionnaire measures the degree to which sleep is disrupted and the quality of sleep experienced by participants, and was used to assess sleep quality in parents. Score range is: 0-21. Higher scores indicate lower sleep quality.
Outcome measures
| Measure |
CGM at Diagnosis of T1D
n=32 Participants
Participants start non-adjunctive use of CGM at diagnosis of T1D and continue for 6 months.
CGM at diagnosis of T1D: Initiation of non-adjunctive CGM use at diagnosis of T1D
Both groups followed through for up to 24 months
|
Usual Care
n=14 Participants
Participants receive usual care for T1D for 6 months post diagnosis.
Both groups followed through for up to 24 months
|
|---|---|---|
|
Pittsburgh Sleep Quality Index
Parent - baseline
|
7.04 score on a scale
Standard Deviation 3.03
|
7.57 score on a scale
Standard Deviation 3.9
|
|
Pittsburgh Sleep Quality Index
Parent - 24 months
|
6.1 score on a scale
Standard Deviation 3.06
|
5.56 score on a scale
Standard Deviation 2.96
|
SECONDARY outcome
Timeframe: Baseline, 24 monthsPopulation: Parent participants with complete data are included in the analysis. Youth did not complete this measure.
People with diabetes worry about hypoglycemia, and was used to assess parent's worry about their child. This measure captures those worries. Score range: 0-72. Higher scores indicate greater fear and worry of hypoglycemia.
Outcome measures
| Measure |
CGM at Diagnosis of T1D
n=32 Participants
Participants start non-adjunctive use of CGM at diagnosis of T1D and continue for 6 months.
CGM at diagnosis of T1D: Initiation of non-adjunctive CGM use at diagnosis of T1D
Both groups followed through for up to 24 months
|
Usual Care
n=14 Participants
Participants receive usual care for T1D for 6 months post diagnosis.
Both groups followed through for up to 24 months
|
|---|---|---|
|
Hypoglycemic Fear Survey
Parent - baseline
|
23.67 score on a scale
Standard Deviation 12.56
|
23.86 score on a scale
Standard Deviation 16.04
|
|
Hypoglycemic Fear Survey
Parent - 24 months
|
21.45 score on a scale
Standard Deviation 15.42
|
19.62 score on a scale
Standard Deviation 14.5
|
SECONDARY outcome
Timeframe: Baseline, 24 monthsPopulation: Participants with complete data (by youth and parent) are included in the analysis.
Hypoglycemia needs to be managed in various daily situations. This questionnaire captures confidence of the participants in those various situations, and was used to assess parent's confidence. Score range: 8-32. Higher scores indicate greater confidence to manage hypoglycemia.
Outcome measures
| Measure |
CGM at Diagnosis of T1D
n=49 Participants
Participants start non-adjunctive use of CGM at diagnosis of T1D and continue for 6 months.
CGM at diagnosis of T1D: Initiation of non-adjunctive CGM use at diagnosis of T1D
Both groups followed through for up to 24 months
|
Usual Care
n=21 Participants
Participants receive usual care for T1D for 6 months post diagnosis.
Both groups followed through for up to 24 months
|
|---|---|---|
|
Hypoglycemic Confidence Questionnaire
Youth - baseline
|
23.65 score on a scale
Standard Deviation 4.93
|
21.18 score on a scale
Standard Deviation 5.55
|
|
Hypoglycemic Confidence Questionnaire
Youth - 24 months
|
26.92 score on a scale
Standard Deviation 4.43
|
27.67 score on a scale
Standard Deviation 8.81
|
|
Hypoglycemic Confidence Questionnaire
Parent - baseline
|
19.46 score on a scale
Standard Deviation 5.93
|
16.11 score on a scale
Standard Deviation 6.21
|
|
Hypoglycemic Confidence Questionnaire
Parent - 24 months
|
24.9 score on a scale
Standard Deviation 4.32
|
23.25 score on a scale
Standard Deviation 5.31
|
SECONDARY outcome
Timeframe: Baseline, 24 monthsPopulation: Participants with complete data (by youth and parent) are included in the analysis.
This measure has questions on attitudes and use of various general technologies (e.g., smartphone) and diabetes devices. Score range: 5-25. Higher scores indicate more positive attitudes about technology.
Outcome measures
| Measure |
CGM at Diagnosis of T1D
n=49 Participants
Participants start non-adjunctive use of CGM at diagnosis of T1D and continue for 6 months.
CGM at diagnosis of T1D: Initiation of non-adjunctive CGM use at diagnosis of T1D
Both groups followed through for up to 24 months
|
Usual Care
n=21 Participants
Participants receive usual care for T1D for 6 months post diagnosis.
Both groups followed through for up to 24 months
|
|---|---|---|
|
General and Diabetes-specific Technology Use
Youth - baseline
|
21 score on a scale
Standard Deviation 2.4
|
19.71 score on a scale
Standard Deviation 4.03
|
|
General and Diabetes-specific Technology Use
Youth - 24 months
|
21.59 score on a scale
Standard Deviation 2.7
|
21 score on a scale
Standard Deviation 5.66
|
|
General and Diabetes-specific Technology Use
Parent - baseline
|
21.19 score on a scale
Standard Deviation 3.04
|
20 score on a scale
Standard Deviation 3.19
|
|
General and Diabetes-specific Technology Use
Parent - 24 months
|
21.19 score on a scale
Standard Deviation 3.8
|
21.92 score on a scale
Standard Deviation 2.87
|
SECONDARY outcome
Timeframe: Baseline, 24 monthsPopulation: Youth participants with complete data are included in the analysis. Parents did not complete this measure.
This is a widely used measure of depression, and was used to assess depression symptoms in youths. Score range: 0-60. Higher scores indicate greater symptoms.
Outcome measures
| Measure |
CGM at Diagnosis of T1D
n=14 Participants
Participants start non-adjunctive use of CGM at diagnosis of T1D and continue for 6 months.
CGM at diagnosis of T1D: Initiation of non-adjunctive CGM use at diagnosis of T1D
Both groups followed through for up to 24 months
|
Usual Care
n=7 Participants
Participants receive usual care for T1D for 6 months post diagnosis.
Both groups followed through for up to 24 months
|
|---|---|---|
|
Center for Epidemiologic Studies Depression Measure
Youth - 24 months
|
13.76 score on a scale
Standard Deviation 12.44
|
10.64 score on a scale
Standard Deviation 7.44
|
|
Center for Epidemiologic Studies Depression Measure
Youth - baseline
|
15.35 score on a scale
Standard Deviation 10.28
|
9.57 score on a scale
Standard Deviation 5.91
|
SECONDARY outcome
Timeframe: Baseline, 24 monthsPopulation: Youth participants with complete data are included in the analysis. Parents did not complete this measure.
Widely used measure of quality of life that is used to generate quality-adjusted life years, and was used to assess health symptoms in youth. Each score scale is 0 to 4, with scores of 3 or 4 denoting more severe problems. The count of participants responding 3 or higher for each parameter are presented.
Outcome measures
| Measure |
CGM at Diagnosis of T1D
n=17 Participants
Participants start non-adjunctive use of CGM at diagnosis of T1D and continue for 6 months.
CGM at diagnosis of T1D: Initiation of non-adjunctive CGM use at diagnosis of T1D
Both groups followed through for up to 24 months
|
Usual Care
n=7 Participants
Participants receive usual care for T1D for 6 months post diagnosis.
Both groups followed through for up to 24 months
|
|---|---|---|
|
Child Health Utility 9D
Youth - baseline worried
|
2 Participants
|
1 Participants
|
|
Child Health Utility 9D
Youth - 24 months worried
|
0 Participants
|
0 Participants
|
|
Child Health Utility 9D
Youth - baseline sad
|
2 Participants
|
1 Participants
|
|
Child Health Utility 9D
Youth - 24 months sad
|
1 Participants
|
0 Participants
|
|
Child Health Utility 9D
Youth - baseline pain
|
0 Participants
|
0 Participants
|
|
Child Health Utility 9D
Youth - 24 months pain
|
1 Participants
|
0 Participants
|
|
Child Health Utility 9D
Youth - baseline tired
|
4 Participants
|
0 Participants
|
|
Child Health Utility 9D
Youth - 24 months tired
|
3 Participants
|
0 Participants
|
|
Child Health Utility 9D
Youth - baseline annoyed
|
2 Participants
|
0 Participants
|
|
Child Health Utility 9D
Youth - 24 months annoyed
|
1 Participants
|
0 Participants
|
|
Child Health Utility 9D
Youth - baseline schoolwork
|
2 Participants
|
0 Participants
|
|
Child Health Utility 9D
Youth - 24 months schoolwork
|
1 Participants
|
0 Participants
|
|
Child Health Utility 9D
Youth - baseline sleep
|
1 Participants
|
1 Participants
|
|
Child Health Utility 9D
Youth - 24 months sleep
|
0 Participants
|
0 Participants
|
|
Child Health Utility 9D
Youth - baseline routine
|
0 Participants
|
0 Participants
|
|
Child Health Utility 9D
Youth - 24 months routine
|
0 Participants
|
0 Participants
|
|
Child Health Utility 9D
Youth - baseline activities
|
1 Participants
|
0 Participants
|
|
Child Health Utility 9D
Youth - 24 months activities
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, 24 monthsPopulation: Youth participants with complete data are included in the analysis. Parents are not included in this measure.
The hemoglobin A1c value is a biologic measure of the glycemia that is the gold standard measure of "control" of diabetes. Collected through a blood sample.
Outcome measures
| Measure |
CGM at Diagnosis of T1D
n=38 Participants
Participants start non-adjunctive use of CGM at diagnosis of T1D and continue for 6 months.
CGM at diagnosis of T1D: Initiation of non-adjunctive CGM use at diagnosis of T1D
Both groups followed through for up to 24 months
|
Usual Care
n=13 Participants
Participants receive usual care for T1D for 6 months post diagnosis.
Both groups followed through for up to 24 months
|
|---|---|---|
|
Hemoglobin A1c
Youth - baseline
|
10.61 mg/dL
Standard Deviation 2.02
|
10.64 mg/dL
Standard Deviation 2.5
|
|
Hemoglobin A1c
Youth - 24 months
|
8.17 mg/dL
Standard Deviation 1.77
|
7.5 mg/dL
Standard Deviation 1.54
|
SECONDARY outcome
Timeframe: Baseline, 24 monthsPopulation: Youth participants with complete data are included in the analysis. Parent data was not collected.
This is a biologic measure of endogenous production and is collected through a blood sample.
Outcome measures
| Measure |
CGM at Diagnosis of T1D
n=31 Participants
Participants start non-adjunctive use of CGM at diagnosis of T1D and continue for 6 months.
CGM at diagnosis of T1D: Initiation of non-adjunctive CGM use at diagnosis of T1D
Both groups followed through for up to 24 months
|
Usual Care
n=12 Participants
Participants receive usual care for T1D for 6 months post diagnosis.
Both groups followed through for up to 24 months
|
|---|---|---|
|
C-peptide
Youth - baseline
|
0.66 ng/mL
Standard Deviation 0.43
|
0.55 ng/mL
Standard Deviation 0.29
|
|
C-peptide
Youth - 24 months
|
0.14 ng/mL
Standard Deviation 0.22
|
0.15 ng/mL
Standard Deviation 0.17
|
Adverse Events
CGM at Diagnosis of T1D
Usual Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place