Trial Outcomes & Findings for Feasibility of a Decision Support System to Reduce Glucose Variability in Subject With T1DM (NCT NCT02558491)
NCT ID: NCT02558491
Last Updated: 2024-08-07
Results Overview
Assess effectiveness of glucose variability (GV) advisory system in reducing glucose variability in T1DM patient using an insulin pump.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
33 participants
Primary outcome timeframe
Duration of the 48 hour study admission
Results posted on
2024-08-07
Participant Flow
Thirty-three subjects started the study. Nine discontinued after starting the study intervention: (1) data collection issues,(1) insulin parameter change needed, (5) personal reasons, and two subjects met stopping criteria - (1) glucagon \& (1) high ketones; 24 subjects completed the protocol.
Blinded continuous glucose monitor (CGM) data will be collected for \~28 days prior to the Experimental Admission and analyzed by the study team to determine the optimal insulin therapy parameters for each insulin pump and multiple daily injections (MDI) participant. These optimized parameters will be used during the \~48 hour Experimental Admission.
Participant milestones
| Measure |
Experimental (Decision Support) Admission, Then Control (Usual Care) Admission
Blinded CGM data was collected for \~28 days prior to the Experimental Admission \& analyzed by the study team to determine the optimal insulin therapy parameters that would be used during the \~48 hour admission. Participants were instructed to record all meal information (i.e. carbohydrate quantity, insulin and self-monitoring blood glucose \[SMBGs\]) in the insulin pump during this Data Collection Phase.
During the Experimental Admission, the DiAs (controlling the study pump) was programmed with the new optimized basal rates, correction factor, and carbohydrate ratios. These new parameters were applied during the entire admission. Once the insulin pump was functional, the pump dispensed insulin based on the optimized basal rates. The DiAs was "blinded", meaning the DiAs User Interface didn't display the CGM value, the DiAs plots, nor the amount of insulin dispensed. The admission was 48 hrs with controlled meals and exercise.
During the Control Admission, the DiAs (controlling the study pump) was programmed with the subject's personnel parameters. The study subject determined the amount of insulin treatment during the admission. Subjects interacted with DiAs as a conventional bolus wizard. The admission was 48 hrs with controlled meals and exercise.
The Experimental and Control Admission were separated by approximately 4 weeks, 8 weeks or 12 weeks.
|
Control (Usual Care) Admission, Then Experimental (Decision Support) Admission
During the Control Admission, the DiAs (controlling the study pump) was programmed with the subject's personal parameters. The study subject determined the amount of insulin treatment during the admission. Subjects interacted with DiAs as a conventional bolus wizard. The admission was 48 hrs with controlled meals and exercise.
Blinded CGM data was collected for \~28 days prior to the Experimental Admission \& analyzed by the study team to determine the optimal insulin therapy parameters that would be used during the \~48 hour admission. Participants were instructed to record all meal information (i.e. carbohydrate quantity, insulin and self-monitoring blood glucose \[SMBGs\]) in the insulin pump during this Data Collection Phase.
During the Experimental Admission, the DiAs (controlling the study pump) was programmed with the new optimized basal rates, correction factor, and carbohydrate ratios. These new parameters were applied during the entire admission. Once the insulin pump was functional, the pump dispensed insulin based on the optimized basal rates. The DiAs was "blinded", meaning the DiAs User Interface didn't display the CGM value, the DiAs plots, nor the amount of insulin dispensed. The admission was 48 hrs with controlled meals and exercise.
The Experimental and Control Admission were separated by approximately 4 weeks, 8 weeks or 12 weeks.
|
|---|---|---|
|
First Invention
STARTED
|
19
|
14
|
|
First Invention
COMPLETED
|
14
|
12
|
|
First Invention
NOT COMPLETED
|
5
|
2
|
|
Second Intervention
STARTED
|
14
|
12
|
|
Second Intervention
COMPLETED
|
12
|
12
|
|
Second Intervention
NOT COMPLETED
|
2
|
0
|
|
Third Intervention
STARTED
|
12
|
12
|
|
Third Intervention
COMPLETED
|
12
|
12
|
|
Third Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Experimental (Decision Support) Admission, Then Control (Usual Care) Admission
Blinded CGM data was collected for \~28 days prior to the Experimental Admission \& analyzed by the study team to determine the optimal insulin therapy parameters that would be used during the \~48 hour admission. Participants were instructed to record all meal information (i.e. carbohydrate quantity, insulin and self-monitoring blood glucose \[SMBGs\]) in the insulin pump during this Data Collection Phase.
During the Experimental Admission, the DiAs (controlling the study pump) was programmed with the new optimized basal rates, correction factor, and carbohydrate ratios. These new parameters were applied during the entire admission. Once the insulin pump was functional, the pump dispensed insulin based on the optimized basal rates. The DiAs was "blinded", meaning the DiAs User Interface didn't display the CGM value, the DiAs plots, nor the amount of insulin dispensed. The admission was 48 hrs with controlled meals and exercise.
During the Control Admission, the DiAs (controlling the study pump) was programmed with the subject's personnel parameters. The study subject determined the amount of insulin treatment during the admission. Subjects interacted with DiAs as a conventional bolus wizard. The admission was 48 hrs with controlled meals and exercise.
The Experimental and Control Admission were separated by approximately 4 weeks, 8 weeks or 12 weeks.
|
Control (Usual Care) Admission, Then Experimental (Decision Support) Admission
During the Control Admission, the DiAs (controlling the study pump) was programmed with the subject's personal parameters. The study subject determined the amount of insulin treatment during the admission. Subjects interacted with DiAs as a conventional bolus wizard. The admission was 48 hrs with controlled meals and exercise.
Blinded CGM data was collected for \~28 days prior to the Experimental Admission \& analyzed by the study team to determine the optimal insulin therapy parameters that would be used during the \~48 hour admission. Participants were instructed to record all meal information (i.e. carbohydrate quantity, insulin and self-monitoring blood glucose \[SMBGs\]) in the insulin pump during this Data Collection Phase.
During the Experimental Admission, the DiAs (controlling the study pump) was programmed with the new optimized basal rates, correction factor, and carbohydrate ratios. These new parameters were applied during the entire admission. Once the insulin pump was functional, the pump dispensed insulin based on the optimized basal rates. The DiAs was "blinded", meaning the DiAs User Interface didn't display the CGM value, the DiAs plots, nor the amount of insulin dispensed. The admission was 48 hrs with controlled meals and exercise.
The Experimental and Control Admission were separated by approximately 4 weeks, 8 weeks or 12 weeks.
|
|---|---|---|
|
First Invention
Withdrawal by Subject
|
3
|
1
|
|
First Invention
Data collection issues
|
1
|
0
|
|
First Invention
Stopping criteria
|
0
|
1
|
|
First Invention
Changed parameters during trial
|
1
|
0
|
|
Second Intervention
Withdrawal by Subject
|
1
|
0
|
|
Second Intervention
Stopping Criteria
|
1
|
0
|
Baseline Characteristics
Feasibility of a Decision Support System to Reduce Glucose Variability in Subject With T1DM
Baseline characteristics by cohort
| Measure |
All Participants
n=24 Participants
Baseline characteristics of all study participants regardless of randomization.
|
|---|---|
|
Body Mass Index (BMI), kg/m2
|
27.4 kg/m^2
STANDARD_DEVIATION 4.6 • n=5 Participants
|
|
Total Daily Insulin (TDI)
|
46.7 U
STANDARD_DEVIATION 22.3 • n=5 Participants
|
|
Age, Continuous
|
37 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Type 1 Diabetes Mellitus (T1DM) duration
|
21 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
|
Hemoglobin A1c (HbA1c)
|
7.2 percentage
STANDARD_DEVIATION 1 • n=5 Participants
|
|
Height
|
172 cm
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Weight
|
81.8 kg
STANDARD_DEVIATION 19.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: Duration of the 48 hour study admissionPopulation: 24 participants completed the study. Data from subjects who withdrew were removed from analysis regardless of the degree of protocol completion.
Assess effectiveness of glucose variability (GV) advisory system in reducing glucose variability in T1DM patient using an insulin pump.
Outcome measures
| Measure |
Decision Support System
n=24 Participants
Blinded CGM data was collected prior to the Experimental Admission and analyzed by the study team to determine the optimal insulin therapy parameters that was used during the Experimental Admission. The system was deployed on a portable medical application platform (DiAs) and include the following elements:
1. An insulin pump treatment parameters optimization routine, using a month of collected CGM/insulin/meal data
2. An exercise risk warning system, capable of predicting hypoglycemia at the onset of physical activity and advising on mitigating alteration of treatment.
|
Usual Care (Control)
n=24 Participants
Subjects used their own insulin parameters, including basal rate, correction factor and carbohydrate-insulin ratio, and determine their own insulin usage during the Control Admission.
|
|---|---|---|
|
Glucose Variability (Coefficient of Variation)
Overall
|
0.33 coefficient of variation
Standard Deviation 0.06
|
0.36 coefficient of variation
Standard Deviation 0.08
|
|
Glucose Variability (Coefficient of Variation)
Mealtime (4h following lunch and dinner)
|
0.3 coefficient of variation
Standard Deviation 0.07
|
0.34 coefficient of variation
Standard Deviation 0.09
|
|
Glucose Variability (Coefficient of Variation)
Overnight (11 pm-7 am)
|
0.25 coefficient of variation
Standard Deviation 0.08
|
0.28 coefficient of variation
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am).Population: 24 participants completed the study. Data from subjects who withdrew were removed from analysis regardless of the degree of protocol completion.
Low blood glucose index (LBGI) by CGM with higher index indicating higher risk of hypoglycemia. Values \<1 suggest minimal risk. Index of risk of low blood glucose excursion based on a standard formula for non-linear transformation of the blood glucose scale (Kovatchev BP, Cox DJ, Gonder-Frederick LA, Young-Hyman D, Schlundt D, Clarke WL: Assessment of risk for severe hypoglycemia among adults with IDDM (Insulin dependent diabetes mellitus): validation of the low blood glucose index. Diabetes Care 21:1870-1875, 1998)
Outcome measures
| Measure |
Decision Support System
n=24 Participants
Blinded CGM data was collected prior to the Experimental Admission and analyzed by the study team to determine the optimal insulin therapy parameters that was used during the Experimental Admission. The system was deployed on a portable medical application platform (DiAs) and include the following elements:
1. An insulin pump treatment parameters optimization routine, using a month of collected CGM/insulin/meal data
2. An exercise risk warning system, capable of predicting hypoglycemia at the onset of physical activity and advising on mitigating alteration of treatment.
|
Usual Care (Control)
n=24 Participants
Subjects used their own insulin parameters, including basal rate, correction factor and carbohydrate-insulin ratio, and determine their own insulin usage during the Control Admission.
|
|---|---|---|
|
Low Blood Glucose Index (LBGI)
Overall
|
1.59 LBGI
Standard Deviation 1.27
|
2.49 LBGI
Standard Deviation 2.08
|
|
Low Blood Glucose Index (LBGI)
Overnight
|
1.89 LBGI
Standard Deviation 1.83
|
2.18 LBGI
Standard Deviation 1.96
|
SECONDARY outcome
Timeframe: 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am), and around meals (the 4 h following lunch and dinner, breakfast excluded due to exercise).Population: 24 participants completed the study. Data from subjects who withdrew were removed from analysis regardless of the degree of protocol completion.
CGM measured blood sugar values below 50 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 50 mg/dL is considered a better outcome.
Outcome measures
| Measure |
Decision Support System
n=24 Participants
Blinded CGM data was collected prior to the Experimental Admission and analyzed by the study team to determine the optimal insulin therapy parameters that was used during the Experimental Admission. The system was deployed on a portable medical application platform (DiAs) and include the following elements:
1. An insulin pump treatment parameters optimization routine, using a month of collected CGM/insulin/meal data
2. An exercise risk warning system, capable of predicting hypoglycemia at the onset of physical activity and advising on mitigating alteration of treatment.
|
Usual Care (Control)
n=24 Participants
Subjects used their own insulin parameters, including basal rate, correction factor and carbohydrate-insulin ratio, and determine their own insulin usage during the Control Admission.
|
|---|---|---|
|
Percent Below 50 mg/dL
Overall
|
0 percentage of time
Interval 0.0 to 0.0
|
0 percentage of time
Interval 0.0 to 0.7
|
|
Percent Below 50 mg/dL
Mealtime
|
0 percentage of time
Interval 0.0 to 0.0
|
0 percentage of time
Interval 0.0 to 0.0
|
|
Percent Below 50 mg/dL
Overnight
|
0 percentage of time
Interval 0.0 to 0.0
|
0 percentage of time
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am), and around meals (the 4 h following lunch and dinner, breakfast excluded due to exercise).Population: 24 participants completed the study. Data from subjects who withdrew were removed from analysis regardless of the degree of protocol completion.
CGM measured blood sugar values below 60 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 60 mg/dL is considered a better outcome.
Outcome measures
| Measure |
Decision Support System
n=24 Participants
Blinded CGM data was collected prior to the Experimental Admission and analyzed by the study team to determine the optimal insulin therapy parameters that was used during the Experimental Admission. The system was deployed on a portable medical application platform (DiAs) and include the following elements:
1. An insulin pump treatment parameters optimization routine, using a month of collected CGM/insulin/meal data
2. An exercise risk warning system, capable of predicting hypoglycemia at the onset of physical activity and advising on mitigating alteration of treatment.
|
Usual Care (Control)
n=24 Participants
Subjects used their own insulin parameters, including basal rate, correction factor and carbohydrate-insulin ratio, and determine their own insulin usage during the Control Admission.
|
|---|---|---|
|
Percent Below 60 mg/dL
Overall
|
0.1 percentage of time
Interval 0.0 to 0.5
|
0.66 percentage of time
Interval 0.0 to 1.6
|
|
Percent Below 60 mg/dL
Mealtime
|
0 percentage of time
Interval 0.0 to 0.4
|
0 percentage of time
Interval 0.0 to 1.7
|
|
Percent Below 60 mg/dL
Overnight
|
0 percentage of time
Interval 0.0 to 0.3
|
0 percentage of time
Interval 0.0 to 1.9
|
SECONDARY outcome
Timeframe: 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am), and around meals (the 4 h following lunch and dinner, breakfast excluded due to exercise).Population: 24 participants completed the study. Data from subjects who withdrew were removed from analysis regardless of the degree of protocol completion.
CGM measured blood sugar values below 70 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 70 mg/dL is considered a better outcome.
Outcome measures
| Measure |
Decision Support System
n=24 Participants
Blinded CGM data was collected prior to the Experimental Admission and analyzed by the study team to determine the optimal insulin therapy parameters that was used during the Experimental Admission. The system was deployed on a portable medical application platform (DiAs) and include the following elements:
1. An insulin pump treatment parameters optimization routine, using a month of collected CGM/insulin/meal data
2. An exercise risk warning system, capable of predicting hypoglycemia at the onset of physical activity and advising on mitigating alteration of treatment.
|
Usual Care (Control)
n=24 Participants
Subjects used their own insulin parameters, including basal rate, correction factor and carbohydrate-insulin ratio, and determine their own insulin usage during the Control Admission.
|
|---|---|---|
|
Percent Below 70 mg/dL
Overall
|
0.88 percentage of time
Interval 0.4 to 2.3
|
3.21 percentage of time
Interval 1.3 to 4.8
|
|
Percent Below 70 mg/dL
Mealtime
|
1.23 percentage of time
Interval 0.0 to 3.2
|
1.73 percentage of time
Interval 0.5 to 5.2
|
|
Percent Below 70 mg/dL
Overnight
|
1.15 percentage of time
Interval 0.0 to 3.2
|
3.33 percentage of time
Interval 0.0 to 5.6
|
SECONDARY outcome
Timeframe: 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am), and around meals (the 4 h following lunch and dinner, breakfast excluded due to exercise).Population: 24 participants completed the study. Data from subjects who withdrew were removed from analysis regardless of the degree of protocol completion.
CGM measured blood sugar values between 70 abd 180 mg/dL are considered to be desirable. A higher percentage of time in this range is indicative of a desirable outcome.
Outcome measures
| Measure |
Decision Support System
n=24 Participants
Blinded CGM data was collected prior to the Experimental Admission and analyzed by the study team to determine the optimal insulin therapy parameters that was used during the Experimental Admission. The system was deployed on a portable medical application platform (DiAs) and include the following elements:
1. An insulin pump treatment parameters optimization routine, using a month of collected CGM/insulin/meal data
2. An exercise risk warning system, capable of predicting hypoglycemia at the onset of physical activity and advising on mitigating alteration of treatment.
|
Usual Care (Control)
n=24 Participants
Subjects used their own insulin parameters, including basal rate, correction factor and carbohydrate-insulin ratio, and determine their own insulin usage during the Control Admission.
|
|---|---|---|
|
Percent Between 70 and 180 mg/dL
Overall
|
68.9 percentage of time
Standard Deviation 14.3
|
65.9 percentage of time
Standard Deviation 18.6
|
|
Percent Between 70 and 180 mg/dL
Mealtime
|
77.9 percentage of time
Standard Deviation 19.2
|
73.3 percentage of time
Standard Deviation 27.3
|
|
Percent Between 70 and 180 mg/dL
Overnight
|
68.2 percentage of time
Standard Deviation 20.3
|
63 percentage of time
Standard Deviation 23.5
|
SECONDARY outcome
Timeframe: 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am), and around meals (the 4 h following lunch and dinner, breakfast excluded due to exercise).Population: 24 participants completed the study. Data from subjects who withdrew were removed from analysis regardless of the degree of protocol completion.
CGM measured blood sugar values above 180 mg/dL are considered to be undesirable. Thus, less time spent above 180 mg/dL is considered a positive outcome
Outcome measures
| Measure |
Decision Support System
n=24 Participants
Blinded CGM data was collected prior to the Experimental Admission and analyzed by the study team to determine the optimal insulin therapy parameters that was used during the Experimental Admission. The system was deployed on a portable medical application platform (DiAs) and include the following elements:
1. An insulin pump treatment parameters optimization routine, using a month of collected CGM/insulin/meal data
2. An exercise risk warning system, capable of predicting hypoglycemia at the onset of physical activity and advising on mitigating alteration of treatment.
|
Usual Care (Control)
n=24 Participants
Subjects used their own insulin parameters, including basal rate, correction factor and carbohydrate-insulin ratio, and determine their own insulin usage during the Control Admission.
|
|---|---|---|
|
Percent Above 180 mg/dL
Overall
|
29.4 percentage of time
Standard Deviation 15.6
|
30.3 percentage of time
Standard Deviation 19.5
|
|
Percent Above 180 mg/dL
Mealtime
|
19.9 percentage of time
Standard Deviation 20.4
|
23.6 percentage of time
Standard Deviation 27.9
|
|
Percent Above 180 mg/dL
Overnight
|
29.2 percentage of time
Standard Deviation 21.7
|
31.2 percentage of time
Standard Deviation 25
|
SECONDARY outcome
Timeframe: 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am), and around meals (the 4 h following lunch and dinner, breakfast excluded due to exercise).Population: 24 participants completed the study. Data from subjects who withdrew were removed from analysis regardless of the degree of protocol completion.
CGM measured blood sugar values above 250 mg/dL are considered to be undesirable. Thus, less time spent above 250 mg/dL is considered a positive outcome
Outcome measures
| Measure |
Decision Support System
n=24 Participants
Blinded CGM data was collected prior to the Experimental Admission and analyzed by the study team to determine the optimal insulin therapy parameters that was used during the Experimental Admission. The system was deployed on a portable medical application platform (DiAs) and include the following elements:
1. An insulin pump treatment parameters optimization routine, using a month of collected CGM/insulin/meal data
2. An exercise risk warning system, capable of predicting hypoglycemia at the onset of physical activity and advising on mitigating alteration of treatment.
|
Usual Care (Control)
n=24 Participants
Subjects used their own insulin parameters, including basal rate, correction factor and carbohydrate-insulin ratio, and determine their own insulin usage during the Control Admission.
|
|---|---|---|
|
Percent Above 250 mg/dL
Overall
|
5.2 percentage of time
Interval 0.0 to 11.5
|
6.3 percentage of time
Interval 3.5 to 14.7
|
|
Percent Above 250 mg/dL
Mealtime
|
0 percentage of time
Interval 0.0 to 0.1
|
0 percentage of time
Interval 0.0 to 8.9
|
|
Percent Above 250 mg/dL
Overnight
|
0 percentage of time
Interval 0.0 to 8.6
|
7.4 percentage of time
Interval 0.0 to 15.9
|
SECONDARY outcome
Timeframe: 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am), and around meals (the 4 h following lunch and dinner, breakfast excluded due to exercise).Population: 24 participants completed the study. Data from subjects who withdrew were removed from analysis regardless of the degree of protocol completion.
CGM measured blood sugar values above 300 mg/dL are considered to be undesirable. Thus, less time spent above 300 mg/dL is considered a positive outcome
Outcome measures
| Measure |
Decision Support System
n=24 Participants
Blinded CGM data was collected prior to the Experimental Admission and analyzed by the study team to determine the optimal insulin therapy parameters that was used during the Experimental Admission. The system was deployed on a portable medical application platform (DiAs) and include the following elements:
1. An insulin pump treatment parameters optimization routine, using a month of collected CGM/insulin/meal data
2. An exercise risk warning system, capable of predicting hypoglycemia at the onset of physical activity and advising on mitigating alteration of treatment.
|
Usual Care (Control)
n=24 Participants
Subjects used their own insulin parameters, including basal rate, correction factor and carbohydrate-insulin ratio, and determine their own insulin usage during the Control Admission.
|
|---|---|---|
|
Percent Above 300 mg/dL
Overall
|
0 percentage of time
Interval 0.0 to 4.5
|
1 percentage of time
Interval 0.0 to 2.6
|
|
Percent Above 300 mg/dL
Mealtime
|
0 percentage of time
Interval 0.0 to 0.0
|
0 percentage of time
Interval 0.0 to 0.0
|
|
Percent Above 300 mg/dL
Overnight
|
0 percentage of time
Interval 0.0 to 0.0
|
0 percentage of time
Interval 0.0 to 4.0
|
SECONDARY outcome
Timeframe: 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am), and around meals (the 4 h following lunch and dinner, breakfast excluded due to exercise).Population: 24 participants completed the study. Data from subjects who withdrew were removed from analysis regardless of the degree of protocol completion.
Average glycemia is a measure of the average CGM value in mg/dL during the 48 hour study admission. A lower value, without approaching hypoglycemia, is indicative of a desirable outcome.
Outcome measures
| Measure |
Decision Support System
n=24 Participants
Blinded CGM data was collected prior to the Experimental Admission and analyzed by the study team to determine the optimal insulin therapy parameters that was used during the Experimental Admission. The system was deployed on a portable medical application platform (DiAs) and include the following elements:
1. An insulin pump treatment parameters optimization routine, using a month of collected CGM/insulin/meal data
2. An exercise risk warning system, capable of predicting hypoglycemia at the onset of physical activity and advising on mitigating alteration of treatment.
|
Usual Care (Control)
n=24 Participants
Subjects used their own insulin parameters, including basal rate, correction factor and carbohydrate-insulin ratio, and determine their own insulin usage during the Control Admission.
|
|---|---|---|
|
Average Glycemia (mg/dL)
Overnight
|
151.9 mg/dL
Standard Deviation 29.9
|
156.9 mg/dL
Standard Deviation 37.6
|
|
Average Glycemia (mg/dL)
Overall
|
155.2 mg/dL
Standard Deviation 23.2
|
155.2 mg/dL
Standard Deviation 27.1
|
|
Average Glycemia (mg/dL)
Mealtime
|
142.7 mg/dL
Standard Deviation 29.7
|
144 mg/dL
Standard Deviation 35.5
|
SECONDARY outcome
Timeframe: 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am), and around meals (the 4 h following lunch and dinner, breakfast excluded due to exercise).Population: 24 participants completed the study. Data from subjects who withdrew were removed from analysis regardless of the degree of protocol completion.
This measure is an average of the total amount of insulin (both basal and bolus) used by participants during the study admission.
Outcome measures
| Measure |
Decision Support System
n=24 Participants
Blinded CGM data was collected prior to the Experimental Admission and analyzed by the study team to determine the optimal insulin therapy parameters that was used during the Experimental Admission. The system was deployed on a portable medical application platform (DiAs) and include the following elements:
1. An insulin pump treatment parameters optimization routine, using a month of collected CGM/insulin/meal data
2. An exercise risk warning system, capable of predicting hypoglycemia at the onset of physical activity and advising on mitigating alteration of treatment.
|
Usual Care (Control)
n=24 Participants
Subjects used their own insulin parameters, including basal rate, correction factor and carbohydrate-insulin ratio, and determine their own insulin usage during the Control Admission.
|
|---|---|---|
|
Total Insulin Used
|
44.1 U
Standard Deviation 18.4
|
45.5 U
Standard Deviation 22.8
|
SECONDARY outcome
Timeframe: 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am), and around meals (the 4 h following lunch and dinner, breakfast excluded due to exercise).Population: 24 participants completed the study. Data from subjects who withdrew were removed from analysis regardless of the degree of protocol completion.
This measure is an average of the total amount of basal insulin used by participants during the study admission.
Outcome measures
| Measure |
Decision Support System
n=24 Participants
Blinded CGM data was collected prior to the Experimental Admission and analyzed by the study team to determine the optimal insulin therapy parameters that was used during the Experimental Admission. The system was deployed on a portable medical application platform (DiAs) and include the following elements:
1. An insulin pump treatment parameters optimization routine, using a month of collected CGM/insulin/meal data
2. An exercise risk warning system, capable of predicting hypoglycemia at the onset of physical activity and advising on mitigating alteration of treatment.
|
Usual Care (Control)
n=24 Participants
Subjects used their own insulin parameters, including basal rate, correction factor and carbohydrate-insulin ratio, and determine their own insulin usage during the Control Admission.
|
|---|---|---|
|
Basal Insulin Used
|
20.3 U
Standard Deviation 9.1
|
21.4 U
Standard Deviation 11.1
|
SECONDARY outcome
Timeframe: 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am), and around meals (the 4 h following lunch and dinner, breakfast excluded due to exercise).Population: 24 participants completed the study. Data from subjects who withdrew were removed from analysis regardless of the degree of protocol completion.
The average of the total amount of rescue carbohydrates (grams) administered during the study admission under safety protocols. Administering fewer carbohydrates is a desirable outcome because it indicates better control.
Outcome measures
| Measure |
Decision Support System
n=24 Participants
Blinded CGM data was collected prior to the Experimental Admission and analyzed by the study team to determine the optimal insulin therapy parameters that was used during the Experimental Admission. The system was deployed on a portable medical application platform (DiAs) and include the following elements:
1. An insulin pump treatment parameters optimization routine, using a month of collected CGM/insulin/meal data
2. An exercise risk warning system, capable of predicting hypoglycemia at the onset of physical activity and advising on mitigating alteration of treatment.
|
Usual Care (Control)
n=24 Participants
Subjects used their own insulin parameters, including basal rate, correction factor and carbohydrate-insulin ratio, and determine their own insulin usage during the Control Admission.
|
|---|---|---|
|
Total Rescue Carbohydrates (CHO) (Grams)
|
81 g
Standard Deviation 74.2
|
96 g
Standard Deviation 78.1
|
Adverse Events
Decision Support System
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Decision Support System
n=33 participants at risk
Blinded CGM data will be collected prior to the Experimental Admission and analyzed by the study team to determine the optimal insulin therapy parameters that will be used during the Experimental Admission.
Decision Support System: The purpose of this study is to demonstrate the safety and feasibility of a Decision Support System aimed at reducing glucose variability in T1DM patient using an insulin pump. The system will be deployed on our portable medical application platform (DiAs) and will include the following elements:
1. An insulin pump treatment parameters optimization routine, using a month of collected CGM/insulin/meal data
2. An exercise risk warning system, capable of predicting hypoglycemia at the onset of physical activity and advising on mitigating alteration of treatment.
|
Usual Care
n=33 participants at risk
Subjects will use their own insulin parameters, including basal rate, correction factor and carbohydrate-insulin ratio, and determine their own insulin usage during the Control Admission.
|
|---|---|---|
|
Endocrine disorders
Hypoglycemia requiring glucagon administration
|
0.00%
0/33 • Approximately 10 weeks
|
3.0%
1/33 • Number of events 1 • Approximately 10 weeks
|
|
Endocrine disorders
Ketones
|
3.0%
1/33 • Number of events 1 • Approximately 10 weeks
|
0.00%
0/33 • Approximately 10 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory illness
|
0.00%
0/33 • Approximately 10 weeks
|
3.0%
1/33 • Number of events 1 • Approximately 10 weeks
|
|
Infections and infestations
Acute Herpetic Gingivitis
|
0.00%
0/33 • Approximately 10 weeks
|
3.0%
1/33 • Number of events 1 • Approximately 10 weeks
|
|
Musculoskeletal and connective tissue disorders
Ankle fracture
|
0.00%
0/33 • Approximately 10 weeks
|
3.0%
1/33 • Number of events 1 • Approximately 10 weeks
|
|
Injury, poisoning and procedural complications
Bump on head
|
0.00%
0/33 • Approximately 10 weeks
|
3.0%
1/33 • Number of events 1 • Approximately 10 weeks
|
Additional Information
Daniel R. Chernavvsky, MD
University of Virginia Center for Diabetes Technology
Phone: 434-982-0602
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place