Trial Outcomes & Findings for Adapting Diabetes Treatment Expert Systems to Patient in Type 1 Diabetes (NCT NCT04443153)
NCT ID: NCT04443153
Last Updated: 2025-10-28
Results Overview
Glucose Variability (GV) as measured by CGM-based Coefficient of Variation (CV), as recommended by the International Consensus on Use of Continuous Glucose Monitoring.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
88 participants
Primary outcome timeframe
Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention
Results posted on
2025-10-28
Participant Flow
Study enrollment began September 4, 2020, and all study activities were completed on September 19, 2024. As defined in the protocol, a participant is considered enrolled when the informed consent form has been signed by the participant and the study team. Eighty-eight (88) signed consent, and 26 participants screen failed, withdrew, or dropped prior to screening.
Once eligibility and device training was completed, participants completed a minimum of 14 days (if CGM use within the preceding 3 months) or 4 weeks (if no CGM use within the preceding 3 months) of home use of the DiAs system in Sensor-Augmented Mode (SAM). One participant elected to withdraw from the study.
Participant milestones
| Measure |
Escalation
Subjects randomized to this arm will proceed from SAM to PF to DSS
Personalized Feedback: Provides tailored information to the user about what glycemic risk they may be facing as well as how glycemic control and system use looked in the past week. Treatment decision and therapy changes are entirely left to the decision of the user.
Decision Support System: CGM-based system that includes Personalized Feedback (PF) and further assists with treatment recommendations for common metabolic challenges
Sensor Augmented Mode: A mode in Diabetes Assistant (DiAs) that combines Diabetes Assistant, Insulin pump or Multiple Daily Injections, CGM, ketone meters, and glycemic treatment guidelines together to manage diabetes.
|
De-escalation
Subjects randomized to this arm will proceed from DSS to PF to SAM
Personalized Feedback: Provides tailored information to the user about what glycemic risk they may be facing as well as how glycemic control and system use looked in the past week. Treatment decision and therapy changes are entirely left to the decision of the user.
Decision Support System: CGM-based system that includes Personalized Feedback (PF) and further assists with treatment recommendations for common metabolic challenges
Sensor Augmented Mode: A mode in Diabetes Assistant (DiAs) that combines Diabetes Assistant, Insulin pump or Multiple Daily Injections, CGM, ketone meters, and glycemic treatment guidelines together to manage diabetes.
|
|---|---|---|
|
First intervention (8 weeks)
STARTED
|
32
|
29
|
|
First intervention (8 weeks)
COMPLETED
|
30
|
27
|
|
First intervention (8 weeks)
NOT COMPLETED
|
2
|
2
|
|
Second intervention (8 weeks)
STARTED
|
30
|
27
|
|
Second intervention (8 weeks)
COMPLETED
|
27
|
26
|
|
Second intervention (8 weeks)
NOT COMPLETED
|
3
|
1
|
|
Third Intervention (8 weeks)
STARTED
|
27
|
26
|
|
Third Intervention (8 weeks)
COMPLETED
|
27
|
26
|
|
Third Intervention (8 weeks)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Escalation
Subjects randomized to this arm will proceed from SAM to PF to DSS
Personalized Feedback: Provides tailored information to the user about what glycemic risk they may be facing as well as how glycemic control and system use looked in the past week. Treatment decision and therapy changes are entirely left to the decision of the user.
Decision Support System: CGM-based system that includes Personalized Feedback (PF) and further assists with treatment recommendations for common metabolic challenges
Sensor Augmented Mode: A mode in Diabetes Assistant (DiAs) that combines Diabetes Assistant, Insulin pump or Multiple Daily Injections, CGM, ketone meters, and glycemic treatment guidelines together to manage diabetes.
|
De-escalation
Subjects randomized to this arm will proceed from DSS to PF to SAM
Personalized Feedback: Provides tailored information to the user about what glycemic risk they may be facing as well as how glycemic control and system use looked in the past week. Treatment decision and therapy changes are entirely left to the decision of the user.
Decision Support System: CGM-based system that includes Personalized Feedback (PF) and further assists with treatment recommendations for common metabolic challenges
Sensor Augmented Mode: A mode in Diabetes Assistant (DiAs) that combines Diabetes Assistant, Insulin pump or Multiple Daily Injections, CGM, ketone meters, and glycemic treatment guidelines together to manage diabetes.
|
|---|---|---|
|
First intervention (8 weeks)
Withdrawal by Subject
|
2
|
0
|
|
First intervention (8 weeks)
Lost to Follow-up
|
0
|
2
|
|
Second intervention (8 weeks)
Withdrawal by Subject
|
1
|
1
|
|
Second intervention (8 weeks)
Lost to Follow-up
|
2
|
0
|
Baseline Characteristics
Adapting Diabetes Treatment Expert Systems to Patient in Type 1 Diabetes
Baseline characteristics by cohort
| Measure |
Escalation
n=27 Participants
Subjects randomized to this arm will proceed from SAM to PF to DSS
Personalized Feedback: Provides tailored information to the user about what glycemic risk they may be facing as well as how glycemic control and system use looked in the past week. Treatment decision and therapy changes are entirely left to the decision of the user.
Decision Support System: CGM-based system that includes Personalized Feedback (PF) and further assists with treatment recommendations for common metabolic challenges
Sensor Augmented Mode: A mode in Diabetes Assistant (DiAs) that combines Diabetes Assistant, Insulin pump or Multiple Daily Injections, CGM, ketone meters, and glycemic treatment guidelines together to manage diabetes.
|
De-escalation
n=26 Participants
Subjects randomized to this arm will proceed from DSS to PF to SAM
Personalized Feedback: Provides tailored information to the user about what glycemic risk they may be facing as well as how glycemic control and system use looked in the past week. Treatment decision and therapy changes are entirely left to the decision of the user.
Decision Support System: CGM-based system that includes Personalized Feedback (PF) and further assists with treatment recommendations for common metabolic challenges
Sensor Augmented Mode: A mode in Diabetes Assistant (DiAs) that combines Diabetes Assistant, Insulin pump or Multiple Daily Injections, CGM, ketone meters, and glycemic treatment guidelines together to manage diabetes.
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.7 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
36.9 years
STANDARD_DEVIATION 12.7 • n=7 Participants
|
37.3 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
|
Sex/Gender, Customized
Gender · Male
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender · Female
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender · Prefer not to say
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 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
|
|
Highest education level
High school degree or equivalent (e.g., GED)
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Highest education level
Some college but no degree
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Highest education level
Associate degree
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Highest education level
Bachelor degree
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Highest education level
Graduate degree
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Last year household income
Less than $20,000
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Last year household income
$20,000 - $44,999
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Last year household income
$45,000 - $99,999
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Last year household income
$100,000 - $149,999
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Last year household income
$150,000 - $199,999
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Last year household income
More than $200,000
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Last year household income
Prefer not to answer
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Health Insurance
Private insurance through my employer
|
19 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Health Insurance
Self-insured with private health insurance
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Health Insurance
Public state or federal health insurance (Medicaid, Medicare, Veteran's Health Affairs...)
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Health Insurance
Uninsured
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Health Insurance
Prefer not to answer
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Number of participants with each infusion set type
MDI
|
18 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Number of participants with each infusion set type
Pump
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed over the last 4 weeks (Weeks 4 - 8), for each interventionGlucose Variability (GV) as measured by CGM-based Coefficient of Variation (CV), as recommended by the International Consensus on Use of Continuous Glucose Monitoring.
Outcome measures
| Measure |
Escalation
n=27 Participants
Subjects randomized to this arm will proceed from SAM to PF to DSS
Personalized Feedback: Provides tailored information to the user about what glycemic risk they may be facing as well as how glycemic control and system use looked in the past week. Treatment decision and therapy changes are entirely left to the decision of the user.
Decision Support System: CGM-based system that includes Personalized Feedback (PF) and further assists with treatment recommendations for common metabolic challenges
Sensor Augmented Mode: A mode in Diabetes Assistant (DiAs) that combines Diabetes Assistant, Insulin pump or Multiple Daily Injections, CGM, ketone meters, and glycemic treatment guidelines together to manage diabetes.
|
De-escalation
n=26 Participants
Subjects randomized to this arm will proceed from DSS to PF to SAM
Personalized Feedback: Provides tailored information to the user about what glycemic risk they may be facing as well as how glycemic control and system use looked in the past week. Treatment decision and therapy changes are entirely left to the decision of the user.
Decision Support System: CGM-based system that includes Personalized Feedback (PF) and further assists with treatment recommendations for common metabolic challenges
Sensor Augmented Mode: A mode in Diabetes Assistant (DiAs) that combines Diabetes Assistant, Insulin pump or Multiple Daily Injections, CGM, ketone meters, and glycemic treatment guidelines together to manage diabetes.
|
|---|---|---|
|
Glycemic Outcomes
SAM
|
36.3 Percent of coefficient of variation
Standard Deviation 4.0
|
35.7 Percent of coefficient of variation
Standard Deviation 6.7
|
|
Glycemic Outcomes
PF
|
37.5 Percent of coefficient of variation
Standard Deviation 5.3
|
35.8 Percent of coefficient of variation
Standard Deviation 6.0
|
|
Glycemic Outcomes
DSS
|
38.6 Percent of coefficient of variation
Standard Deviation 5.1
|
35.8 Percent of coefficient of variation
Standard Deviation 6.6
|
SECONDARY outcome
Timeframe: Assessed over the last 4 weeks (Weeks 4 - 8), for each interventionPercentage of time blood glucose was below 54mg/dL as per CGM
Outcome measures
| Measure |
Escalation
n=27 Participants
Subjects randomized to this arm will proceed from SAM to PF to DSS
Personalized Feedback: Provides tailored information to the user about what glycemic risk they may be facing as well as how glycemic control and system use looked in the past week. Treatment decision and therapy changes are entirely left to the decision of the user.
Decision Support System: CGM-based system that includes Personalized Feedback (PF) and further assists with treatment recommendations for common metabolic challenges
Sensor Augmented Mode: A mode in Diabetes Assistant (DiAs) that combines Diabetes Assistant, Insulin pump or Multiple Daily Injections, CGM, ketone meters, and glycemic treatment guidelines together to manage diabetes.
|
De-escalation
n=26 Participants
Subjects randomized to this arm will proceed from DSS to PF to SAM
Personalized Feedback: Provides tailored information to the user about what glycemic risk they may be facing as well as how glycemic control and system use looked in the past week. Treatment decision and therapy changes are entirely left to the decision of the user.
Decision Support System: CGM-based system that includes Personalized Feedback (PF) and further assists with treatment recommendations for common metabolic challenges
Sensor Augmented Mode: A mode in Diabetes Assistant (DiAs) that combines Diabetes Assistant, Insulin pump or Multiple Daily Injections, CGM, ketone meters, and glycemic treatment guidelines together to manage diabetes.
|
|---|---|---|
|
Percent Time in Clinical Hypoglycemia
SAM
|
0.5 Percent of time
Standard Deviation 0.8
|
0.7 Percent of time
Standard Deviation 0.7
|
|
Percent Time in Clinical Hypoglycemia
PF
|
0.6 Percent of time
Standard Deviation 0.6
|
0.6 Percent of time
Standard Deviation 1.0
|
|
Percent Time in Clinical Hypoglycemia
DSS
|
0.7 Percent of time
Standard Deviation 0.9
|
0.6 Percent of time
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Assessed over the last 4 weeks (Weeks 4 - 8), for each interventionPercentage of time blood glucose was below 70mg/dL as per CGM
Outcome measures
| Measure |
Escalation
n=27 Participants
Subjects randomized to this arm will proceed from SAM to PF to DSS
Personalized Feedback: Provides tailored information to the user about what glycemic risk they may be facing as well as how glycemic control and system use looked in the past week. Treatment decision and therapy changes are entirely left to the decision of the user.
Decision Support System: CGM-based system that includes Personalized Feedback (PF) and further assists with treatment recommendations for common metabolic challenges
Sensor Augmented Mode: A mode in Diabetes Assistant (DiAs) that combines Diabetes Assistant, Insulin pump or Multiple Daily Injections, CGM, ketone meters, and glycemic treatment guidelines together to manage diabetes.
|
De-escalation
n=26 Participants
Subjects randomized to this arm will proceed from DSS to PF to SAM
Personalized Feedback: Provides tailored information to the user about what glycemic risk they may be facing as well as how glycemic control and system use looked in the past week. Treatment decision and therapy changes are entirely left to the decision of the user.
Decision Support System: CGM-based system that includes Personalized Feedback (PF) and further assists with treatment recommendations for common metabolic challenges
Sensor Augmented Mode: A mode in Diabetes Assistant (DiAs) that combines Diabetes Assistant, Insulin pump or Multiple Daily Injections, CGM, ketone meters, and glycemic treatment guidelines together to manage diabetes.
|
|---|---|---|
|
Percent Time Below Recommended Threshold
SAM
|
2.5 Percentage of time
Standard Deviation 2.4
|
3.5 Percentage of time
Standard Deviation 3.3
|
|
Percent Time Below Recommended Threshold
PF
|
3.1 Percentage of time
Standard Deviation 2.6
|
2.8 Percentage of time
Standard Deviation 2.9
|
|
Percent Time Below Recommended Threshold
DSS
|
2.8 Percentage of time
Standard Deviation 2.3
|
2.9 Percentage of time
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: Assessed over the last 4 weeks (Weeks 4 - 8), for each interventionPercentage of time blood glucose was 70mg/dL and 180mg/dL as per CGM
Outcome measures
| Measure |
Escalation
n=27 Participants
Subjects randomized to this arm will proceed from SAM to PF to DSS
Personalized Feedback: Provides tailored information to the user about what glycemic risk they may be facing as well as how glycemic control and system use looked in the past week. Treatment decision and therapy changes are entirely left to the decision of the user.
Decision Support System: CGM-based system that includes Personalized Feedback (PF) and further assists with treatment recommendations for common metabolic challenges
Sensor Augmented Mode: A mode in Diabetes Assistant (DiAs) that combines Diabetes Assistant, Insulin pump or Multiple Daily Injections, CGM, ketone meters, and glycemic treatment guidelines together to manage diabetes.
|
De-escalation
n=26 Participants
Subjects randomized to this arm will proceed from DSS to PF to SAM
Personalized Feedback: Provides tailored information to the user about what glycemic risk they may be facing as well as how glycemic control and system use looked in the past week. Treatment decision and therapy changes are entirely left to the decision of the user.
Decision Support System: CGM-based system that includes Personalized Feedback (PF) and further assists with treatment recommendations for common metabolic challenges
Sensor Augmented Mode: A mode in Diabetes Assistant (DiAs) that combines Diabetes Assistant, Insulin pump or Multiple Daily Injections, CGM, ketone meters, and glycemic treatment guidelines together to manage diabetes.
|
|---|---|---|
|
Percent Time in Target Range
SAM
|
53.9 Percentage of time
Standard Deviation 16.9
|
60.1 Percentage of time
Standard Deviation 16.9
|
|
Percent Time in Target Range
PF
|
53.6 Percentage of time
Standard Deviation 18.3
|
61.1 Percentage of time
Standard Deviation 16.1
|
|
Percent Time in Target Range
DSS
|
53.3 Percentage of time
Standard Deviation 16.0
|
57.5 Percentage of time
Standard Deviation 15.8
|
SECONDARY outcome
Timeframe: Assessed over the last 4 weeks (Weeks 4 - 8), for each interventionPercentage of time blood glucose was above 180mg/dL as per CGM
Outcome measures
| Measure |
Escalation
n=27 Participants
Subjects randomized to this arm will proceed from SAM to PF to DSS
Personalized Feedback: Provides tailored information to the user about what glycemic risk they may be facing as well as how glycemic control and system use looked in the past week. Treatment decision and therapy changes are entirely left to the decision of the user.
Decision Support System: CGM-based system that includes Personalized Feedback (PF) and further assists with treatment recommendations for common metabolic challenges
Sensor Augmented Mode: A mode in Diabetes Assistant (DiAs) that combines Diabetes Assistant, Insulin pump or Multiple Daily Injections, CGM, ketone meters, and glycemic treatment guidelines together to manage diabetes.
|
De-escalation
n=26 Participants
Subjects randomized to this arm will proceed from DSS to PF to SAM
Personalized Feedback: Provides tailored information to the user about what glycemic risk they may be facing as well as how glycemic control and system use looked in the past week. Treatment decision and therapy changes are entirely left to the decision of the user.
Decision Support System: CGM-based system that includes Personalized Feedback (PF) and further assists with treatment recommendations for common metabolic challenges
Sensor Augmented Mode: A mode in Diabetes Assistant (DiAs) that combines Diabetes Assistant, Insulin pump or Multiple Daily Injections, CGM, ketone meters, and glycemic treatment guidelines together to manage diabetes.
|
|---|---|---|
|
Percent Time Above Range
SAM
|
43.6 Percent of time
Standard Deviation 18.2
|
36.4 Percent of time
Standard Deviation 18.8
|
|
Percent Time Above Range
PF
|
43.3 Percent of time
Standard Deviation 19.7
|
36.1 Percent of time
Standard Deviation 17.4
|
|
Percent Time Above Range
DSS
|
43.9 Percent of time
Standard Deviation 16.7
|
39.6 Percent of time
Standard Deviation 16.6
|
SECONDARY outcome
Timeframe: Assessed over the last 4 weeks (Weeks 4 - 8), for each interventionPercentage of time blood glucose was above 250mg/dL as per CGM
Outcome measures
| Measure |
Escalation
n=27 Participants
Subjects randomized to this arm will proceed from SAM to PF to DSS
Personalized Feedback: Provides tailored information to the user about what glycemic risk they may be facing as well as how glycemic control and system use looked in the past week. Treatment decision and therapy changes are entirely left to the decision of the user.
Decision Support System: CGM-based system that includes Personalized Feedback (PF) and further assists with treatment recommendations for common metabolic challenges
Sensor Augmented Mode: A mode in Diabetes Assistant (DiAs) that combines Diabetes Assistant, Insulin pump or Multiple Daily Injections, CGM, ketone meters, and glycemic treatment guidelines together to manage diabetes.
|
De-escalation
n=26 Participants
Subjects randomized to this arm will proceed from DSS to PF to SAM
Personalized Feedback: Provides tailored information to the user about what glycemic risk they may be facing as well as how glycemic control and system use looked in the past week. Treatment decision and therapy changes are entirely left to the decision of the user.
Decision Support System: CGM-based system that includes Personalized Feedback (PF) and further assists with treatment recommendations for common metabolic challenges
Sensor Augmented Mode: A mode in Diabetes Assistant (DiAs) that combines Diabetes Assistant, Insulin pump or Multiple Daily Injections, CGM, ketone meters, and glycemic treatment guidelines together to manage diabetes.
|
|---|---|---|
|
Percent Time Above 250 mg/dL
SAM
|
16.6 Percentage of time
Standard Deviation 12.6
|
11.4 Percentage of time
Standard Deviation 11.0
|
|
Percent Time Above 250 mg/dL
PF
|
18.4 Percentage of time
Standard Deviation 14.5
|
12.2 Percentage of time
Standard Deviation 12.0
|
|
Percent Time Above 250 mg/dL
DSS
|
19.4 Percentage of time
Standard Deviation 14.8
|
13.3 Percentage of time
Standard Deviation 11.5
|
SECONDARY outcome
Timeframe: Assessed over the last 4 weeks (Weeks 4 - 8), for each interventionaverage of CGM values
Outcome measures
| Measure |
Escalation
n=27 Participants
Subjects randomized to this arm will proceed from SAM to PF to DSS
Personalized Feedback: Provides tailored information to the user about what glycemic risk they may be facing as well as how glycemic control and system use looked in the past week. Treatment decision and therapy changes are entirely left to the decision of the user.
Decision Support System: CGM-based system that includes Personalized Feedback (PF) and further assists with treatment recommendations for common metabolic challenges
Sensor Augmented Mode: A mode in Diabetes Assistant (DiAs) that combines Diabetes Assistant, Insulin pump or Multiple Daily Injections, CGM, ketone meters, and glycemic treatment guidelines together to manage diabetes.
|
De-escalation
n=26 Participants
Subjects randomized to this arm will proceed from DSS to PF to SAM
Personalized Feedback: Provides tailored information to the user about what glycemic risk they may be facing as well as how glycemic control and system use looked in the past week. Treatment decision and therapy changes are entirely left to the decision of the user.
Decision Support System: CGM-based system that includes Personalized Feedback (PF) and further assists with treatment recommendations for common metabolic challenges
Sensor Augmented Mode: A mode in Diabetes Assistant (DiAs) that combines Diabetes Assistant, Insulin pump or Multiple Daily Injections, CGM, ketone meters, and glycemic treatment guidelines together to manage diabetes.
|
|---|---|---|
|
Average Glycemia
SAM
|
179.1 mg/dl
Standard Deviation 32.3
|
164.9 mg/dl
Standard Deviation 31.2
|
|
Average Glycemia
PF
|
179.8 mg/dl
Standard Deviation 35.5
|
167.3 mg/dl
Standard Deviation 30.6
|
|
Average Glycemia
DSS
|
182.2 mg/dl
Standard Deviation 33.0
|
172.2 mg/dl
Standard Deviation 27.5
|
SECONDARY outcome
Timeframe: Assessed over the last 4 weeks (Weeks 4 - 8), for each interventionThe low blood glucose index (LBGI) is based on a nonlinear transformation of blood glucose values that corrects for the asymmetry of the glucose scale. This transformation maps glucose values into a risk space (minimum risk = 0), where higher values correspond to higher risk. Values \<1 suggest low risk of hypoglycemia.
Outcome measures
| Measure |
Escalation
n=27 Participants
Subjects randomized to this arm will proceed from SAM to PF to DSS
Personalized Feedback: Provides tailored information to the user about what glycemic risk they may be facing as well as how glycemic control and system use looked in the past week. Treatment decision and therapy changes are entirely left to the decision of the user.
Decision Support System: CGM-based system that includes Personalized Feedback (PF) and further assists with treatment recommendations for common metabolic challenges
Sensor Augmented Mode: A mode in Diabetes Assistant (DiAs) that combines Diabetes Assistant, Insulin pump or Multiple Daily Injections, CGM, ketone meters, and glycemic treatment guidelines together to manage diabetes.
|
De-escalation
n=26 Participants
Subjects randomized to this arm will proceed from DSS to PF to SAM
Personalized Feedback: Provides tailored information to the user about what glycemic risk they may be facing as well as how glycemic control and system use looked in the past week. Treatment decision and therapy changes are entirely left to the decision of the user.
Decision Support System: CGM-based system that includes Personalized Feedback (PF) and further assists with treatment recommendations for common metabolic challenges
Sensor Augmented Mode: A mode in Diabetes Assistant (DiAs) that combines Diabetes Assistant, Insulin pump or Multiple Daily Injections, CGM, ketone meters, and glycemic treatment guidelines together to manage diabetes.
|
|---|---|---|
|
Low Blood Glucose Index
SAM
|
0.7 index
Standard Deviation 0.5
|
0.9 index
Standard Deviation 0.7
|
|
Low Blood Glucose Index
PF
|
0.8 index
Standard Deviation 0.6
|
0.8 index
Standard Deviation 0.7
|
|
Low Blood Glucose Index
DSS
|
0.8 index
Standard Deviation 0.5
|
0.7 index
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Assessed over the last 4 weeks (Weeks 4 - 8), for each interventionThe high blood glucose index (HBGI) is based on a nonlinear transformation of blood glucose values that corrects for the asymmetry of the glucose scale. This transformation maps glucose values into a risk space (minimum risk = 0), where higher values correspond to higher risk. Values below 10 suggest low to moderate risk.
Outcome measures
| Measure |
Escalation
n=27 Participants
Subjects randomized to this arm will proceed from SAM to PF to DSS
Personalized Feedback: Provides tailored information to the user about what glycemic risk they may be facing as well as how glycemic control and system use looked in the past week. Treatment decision and therapy changes are entirely left to the decision of the user.
Decision Support System: CGM-based system that includes Personalized Feedback (PF) and further assists with treatment recommendations for common metabolic challenges
Sensor Augmented Mode: A mode in Diabetes Assistant (DiAs) that combines Diabetes Assistant, Insulin pump or Multiple Daily Injections, CGM, ketone meters, and glycemic treatment guidelines together to manage diabetes.
|
De-escalation
n=26 Participants
Subjects randomized to this arm will proceed from DSS to PF to SAM
Personalized Feedback: Provides tailored information to the user about what glycemic risk they may be facing as well as how glycemic control and system use looked in the past week. Treatment decision and therapy changes are entirely left to the decision of the user.
Decision Support System: CGM-based system that includes Personalized Feedback (PF) and further assists with treatment recommendations for common metabolic challenges
Sensor Augmented Mode: A mode in Diabetes Assistant (DiAs) that combines Diabetes Assistant, Insulin pump or Multiple Daily Injections, CGM, ketone meters, and glycemic treatment guidelines together to manage diabetes.
|
|---|---|---|
|
High Blood Glucose Index
SAM
|
10.6 index
Standard Deviation 5.7
|
8.3 index
Standard Deviation 5.0
|
|
High Blood Glucose Index
PF
|
11.0 index
Standard Deviation 6.2
|
8.7 index
Standard Deviation 5.3
|
|
High Blood Glucose Index
DSS
|
11.4 index
Standard Deviation 6.2
|
9.4 index
Standard Deviation 4.8
|
Adverse Events
Sensor-augmented mode (SAM)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Personalized Feedback (PF)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Decision support system (DSS)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sensor-augmented mode (SAM)
n=53 participants at risk
Sensor Augmented Mode: A mode in Diabetes Assistant (DiAs) that combines Diabetes Assistant, Insulin pump or Multiple Daily Injections, CGM, ketone meters, and glycemic treatment guidelines together to manage diabetes.
|
Personalized Feedback (PF)
n=53 participants at risk
Personalized Feedback: Provides tailored information to the user about what glycemic risk they may be facing as well as how glycemic control and system use looked in the past week. Treatment decision and therapy changes are entirely left to the decision of the user.
|
Decision support system (DSS)
n=53 participants at risk
Decision Support System: CGM-based system that includes Personalized Feedback (PF) and further assists with treatment recommendations for common metabolic challenges
|
|---|---|---|---|
|
Endocrine disorders
Severe Hypoglycemia
|
0.00%
0/53 • 7 months
Adverse Event definitions are the same as ClinicalTrials.Gov. Please see protocol for further details about adverse event reporting.
|
1.9%
1/53 • Number of events 1 • 7 months
Adverse Event definitions are the same as ClinicalTrials.Gov. Please see protocol for further details about adverse event reporting.
|
0.00%
0/53 • 7 months
Adverse Event definitions are the same as ClinicalTrials.Gov. Please see protocol for further details about adverse event reporting.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place