Trial Outcomes & Findings for Assessment of a Decision Support Tool in Participants With Type 1 Diabetes (NCT NCT04428645)
NCT ID: NCT04428645
Last Updated: 2022-07-19
Results Overview
Mean change in the percent of time with sensed glucose between 70 - 180 mg/dl based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
Weeks 1-2 and 9-10
Results posted on
2022-07-19
Participant Flow
Participant milestones
| Measure |
DailyDose Decision Support
Subjects will use DailyDose decision support for 8 weeks at home.
DailyDose Decision Support: DailyDose provides on-demand, real-time dosing recommendations for insulin meal boluses and basal insulin doses as well as the option to receive recommendations for meals and exercise. DailyDose is an information system comprised of (1) a smart phone app that both collects continuous glucose measurement (CGM) data, insulin data, and fitness data and presents suggestions back to the user, (2) a cloud based information system that stores the raw data and relays suggestions to the user, (3) a glucoregulatory model, automatically personalized for each user, that resides on a cloud server and is fit with the user's individual glucose data, and (4) an adaptive agent that provides insulin dosing options and suggestions as well as meal and exercise recommendations to the user based on the subject's own outcomes and simulations done on the glucoregulatory model.
|
|---|---|
|
Run in Visit Training (2 Hours)
STARTED
|
25
|
|
Run in Visit Training (2 Hours)
COMPLETED
|
25
|
|
Run in Visit Training (2 Hours)
NOT COMPLETED
|
0
|
|
First at Home Period (~2 Weeks)
STARTED
|
25
|
|
First at Home Period (~2 Weeks)
COMPLETED
|
25
|
|
First at Home Period (~2 Weeks)
NOT COMPLETED
|
0
|
|
DailyDose Training Visit (2 Hours)
STARTED
|
25
|
|
DailyDose Training Visit (2 Hours)
COMPLETED
|
25
|
|
DailyDose Training Visit (2 Hours)
NOT COMPLETED
|
0
|
|
Second at Home Period (8 Weeks)
STARTED
|
25
|
|
Second at Home Period (8 Weeks)
COMPLETED
|
24
|
|
Second at Home Period (8 Weeks)
NOT COMPLETED
|
1
|
|
Study Close-out Visit (30 Minutes)
STARTED
|
24
|
|
Study Close-out Visit (30 Minutes)
COMPLETED
|
24
|
|
Study Close-out Visit (30 Minutes)
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
DailyDose Decision Support
Subjects will use DailyDose decision support for 8 weeks at home.
DailyDose Decision Support: DailyDose provides on-demand, real-time dosing recommendations for insulin meal boluses and basal insulin doses as well as the option to receive recommendations for meals and exercise. DailyDose is an information system comprised of (1) a smart phone app that both collects continuous glucose measurement (CGM) data, insulin data, and fitness data and presents suggestions back to the user, (2) a cloud based information system that stores the raw data and relays suggestions to the user, (3) a glucoregulatory model, automatically personalized for each user, that resides on a cloud server and is fit with the user's individual glucose data, and (4) an adaptive agent that provides insulin dosing options and suggestions as well as meal and exercise recommendations to the user based on the subject's own outcomes and simulations done on the glucoregulatory model.
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|---|---|
|
Second at Home Period (8 Weeks)
Withdrawal by Subject
|
1
|
Baseline Characteristics
Assessment of a Decision Support Tool in Participants With Type 1 Diabetes
Baseline characteristics by cohort
| Measure |
DailyDose Decision Support
n=25 Participants
Subjects will use DailyDose decision support for 8 weeks at home.
DailyDose Decision Support: DailyDose provides on-demand, real-time dosing recommendations for insulin meal boluses and basal insulin doses as well as the option to receive recommendations for meals and exercise. DailyDose is an information system comprised of (1) a smart phone app that both collects continuous glucose measurement (CGM) data, insulin data, and fitness data and presents suggestions back to the user, (2) a cloud based information system that stores the raw data and relays suggestions to the user, (3) a glucoregulatory model, automatically personalized for each user, that resides on a cloud server and is fit with the user's individual glucose data, and (4) an adaptive agent that provides insulin dosing options and suggestions as well as meal and exercise recommendations to the user based on the subject's own outcomes and simulations done on the glucoregulatory model.
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|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
35.8 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 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
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 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
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Weeks 1-2 and 9-10Mean change in the percent of time with sensed glucose between 70 - 180 mg/dl based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.
Outcome measures
| Measure |
DailyDose Decision Support
n=24 Participants
Subjects will use DailyDose decision support for 8 weeks at home.
DailyDose Decision Support: DailyDose provides on-demand, real-time dosing recommendations for insulin meal boluses and basal insulin doses as well as the option to receive recommendations for meals and exercise. DailyDose is an information system comprised of (1) a smart phone app that both collects continuous glucose measurement (CGM) data, insulin data, and fitness data and presents suggestions back to the user, (2) a cloud based information system that stores the raw data and relays suggestions to the user, (3) a glucoregulatory model, automatically personalized for each user, that resides on a cloud server and is fit with the user's individual glucose data, and (4) an adaptive agent that provides insulin dosing options and suggestions as well as meal and exercise recommendations to the user based on the subject's own outcomes and simulations done on the glucoregulatory model.
|
|---|---|
|
Mean Change in the Percent of Time With Sensed Glucose Between 70 - 180 mg/dl
|
-3.8 percentage of time
Standard Deviation 15.8
|
SECONDARY outcome
Timeframe: Weeks 1-2 and 9-10Mean change in sensed glucose based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.
Outcome measures
| Measure |
DailyDose Decision Support
n=24 Participants
Subjects will use DailyDose decision support for 8 weeks at home.
DailyDose Decision Support: DailyDose provides on-demand, real-time dosing recommendations for insulin meal boluses and basal insulin doses as well as the option to receive recommendations for meals and exercise. DailyDose is an information system comprised of (1) a smart phone app that both collects continuous glucose measurement (CGM) data, insulin data, and fitness data and presents suggestions back to the user, (2) a cloud based information system that stores the raw data and relays suggestions to the user, (3) a glucoregulatory model, automatically personalized for each user, that resides on a cloud server and is fit with the user's individual glucose data, and (4) an adaptive agent that provides insulin dosing options and suggestions as well as meal and exercise recommendations to the user based on the subject's own outcomes and simulations done on the glucoregulatory model.
|
|---|---|
|
Mean Change in Sensed Glucose
|
11 mg/dL
Standard Deviation 28
|
SECONDARY outcome
Timeframe: Weeks 1-2 and 9-10Mean change in the percent of time with sensed glucose \< 70 mg/dl based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.
Outcome measures
| Measure |
DailyDose Decision Support
n=24 Participants
Subjects will use DailyDose decision support for 8 weeks at home.
DailyDose Decision Support: DailyDose provides on-demand, real-time dosing recommendations for insulin meal boluses and basal insulin doses as well as the option to receive recommendations for meals and exercise. DailyDose is an information system comprised of (1) a smart phone app that both collects continuous glucose measurement (CGM) data, insulin data, and fitness data and presents suggestions back to the user, (2) a cloud based information system that stores the raw data and relays suggestions to the user, (3) a glucoregulatory model, automatically personalized for each user, that resides on a cloud server and is fit with the user's individual glucose data, and (4) an adaptive agent that provides insulin dosing options and suggestions as well as meal and exercise recommendations to the user based on the subject's own outcomes and simulations done on the glucoregulatory model.
|
|---|---|
|
Mean Change in the Percent of Time With Sensed Glucose <70 mg/dl
|
-0.3 percentage of time
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Weeks 1-2 and 9-10Mean change in the percent of time with sensed glucose \< 54 mg/dl based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.
Outcome measures
| Measure |
DailyDose Decision Support
n=24 Participants
Subjects will use DailyDose decision support for 8 weeks at home.
DailyDose Decision Support: DailyDose provides on-demand, real-time dosing recommendations for insulin meal boluses and basal insulin doses as well as the option to receive recommendations for meals and exercise. DailyDose is an information system comprised of (1) a smart phone app that both collects continuous glucose measurement (CGM) data, insulin data, and fitness data and presents suggestions back to the user, (2) a cloud based information system that stores the raw data and relays suggestions to the user, (3) a glucoregulatory model, automatically personalized for each user, that resides on a cloud server and is fit with the user's individual glucose data, and (4) an adaptive agent that provides insulin dosing options and suggestions as well as meal and exercise recommendations to the user based on the subject's own outcomes and simulations done on the glucoregulatory model.
|
|---|---|
|
Mean Change in the Percent of Time With Sensed Glucose <54 mg/dl
|
0.0006 percentage of time
Standard Deviation 0.472
|
SECONDARY outcome
Timeframe: Weeks 1-2 and 9-10Mean change in the percent of time with sensed glucose \>180 mg/dl based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.
Outcome measures
| Measure |
DailyDose Decision Support
n=24 Participants
Subjects will use DailyDose decision support for 8 weeks at home.
DailyDose Decision Support: DailyDose provides on-demand, real-time dosing recommendations for insulin meal boluses and basal insulin doses as well as the option to receive recommendations for meals and exercise. DailyDose is an information system comprised of (1) a smart phone app that both collects continuous glucose measurement (CGM) data, insulin data, and fitness data and presents suggestions back to the user, (2) a cloud based information system that stores the raw data and relays suggestions to the user, (3) a glucoregulatory model, automatically personalized for each user, that resides on a cloud server and is fit with the user's individual glucose data, and (4) an adaptive agent that provides insulin dosing options and suggestions as well as meal and exercise recommendations to the user based on the subject's own outcomes and simulations done on the glucoregulatory model.
|
|---|---|
|
Mean Change in the Percent of Time With Sensed Glucose >180 mg/dl
|
4.1 percentage of time
Standard Deviation 15.9
|
SECONDARY outcome
Timeframe: Weeks 1-2 and 9-10Mean change in the percent of time with sensed glucose \>250 mg/dl based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.
Outcome measures
| Measure |
DailyDose Decision Support
n=24 Participants
Subjects will use DailyDose decision support for 8 weeks at home.
DailyDose Decision Support: DailyDose provides on-demand, real-time dosing recommendations for insulin meal boluses and basal insulin doses as well as the option to receive recommendations for meals and exercise. DailyDose is an information system comprised of (1) a smart phone app that both collects continuous glucose measurement (CGM) data, insulin data, and fitness data and presents suggestions back to the user, (2) a cloud based information system that stores the raw data and relays suggestions to the user, (3) a glucoregulatory model, automatically personalized for each user, that resides on a cloud server and is fit with the user's individual glucose data, and (4) an adaptive agent that provides insulin dosing options and suggestions as well as meal and exercise recommendations to the user based on the subject's own outcomes and simulations done on the glucoregulatory model.
|
|---|---|
|
Mean Change in the Percent of Time With Sensed Glucose >250 mg/dl
|
5.4 percentage of time
Standard Deviation 12.5
|
SECONDARY outcome
Timeframe: Weeks 1-2 and 9-10Change in coefficient of variation of sensor glucose based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.
Outcome measures
| Measure |
DailyDose Decision Support
n=24 Participants
Subjects will use DailyDose decision support for 8 weeks at home.
DailyDose Decision Support: DailyDose provides on-demand, real-time dosing recommendations for insulin meal boluses and basal insulin doses as well as the option to receive recommendations for meals and exercise. DailyDose is an information system comprised of (1) a smart phone app that both collects continuous glucose measurement (CGM) data, insulin data, and fitness data and presents suggestions back to the user, (2) a cloud based information system that stores the raw data and relays suggestions to the user, (3) a glucoregulatory model, automatically personalized for each user, that resides on a cloud server and is fit with the user's individual glucose data, and (4) an adaptive agent that provides insulin dosing options and suggestions as well as meal and exercise recommendations to the user based on the subject's own outcomes and simulations done on the glucoregulatory model.
|
|---|---|
|
Change in Coefficient of Variation of Sensor Glucose Based on the Dexcom G6 CGM Data.
|
-0.3 percent of CV
|
Adverse Events
DailyDose Decision Support
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
DailyDose Decision Support
n=25 participants at risk
Subjects will use DailyDose decision support for 8 weeks at home.
DailyDose Decision Support: DailyDose provides on-demand, real-time dosing recommendations for insulin meal boluses and basal insulin doses as well as the option to receive recommendations for meals and exercise. DailyDose is an information system comprised of (1) a smart phone app that both collects continuous glucose measurement (CGM) data, insulin data, and fitness data and presents suggestions back to the user, (2) a cloud based information system that stores the raw data and relays suggestions to the user, (3) a glucoregulatory model, automatically personalized for each user, that resides on a cloud server and is fit with the user's individual glucose data, and (4) an adaptive agent that provides insulin dosing options and suggestions as well as meal and exercise recommendations to the user based on the subject's own outcomes and simulations done on the glucoregulatory model.
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|---|---|
|
Infections and infestations
upper respiratory infection
|
8.0%
2/25 • Number of events 2 • 10 weeks
All participants that started a visit are included in the adverse events. All subjects completed all visits except one. That subject only completed two of the three visits.
|
|
Infections and infestations
urinary tract infection
|
4.0%
1/25 • Number of events 1 • 10 weeks
All participants that started a visit are included in the adverse events. All subjects completed all visits except one. That subject only completed two of the three visits.
|
|
Infections and infestations
vaginal infection
|
4.0%
1/25 • Number of events 1 • 10 weeks
All participants that started a visit are included in the adverse events. All subjects completed all visits except one. That subject only completed two of the three visits.
|
|
Infections and infestations
strep throat
|
4.0%
1/25 • Number of events 1 • 10 weeks
All participants that started a visit are included in the adverse events. All subjects completed all visits except one. That subject only completed two of the three visits.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place