Evaluation of iDECIDE: A Smartphone App for Insulin Dosing Accounting for Alcohol and Exercise
Primary Purpose
Type 1 Diabetes
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
iDECIDE
Insulin pump
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes
Eligibility Criteria
Inclusion Criteria:
- Mayo Clinic Arizona type 1 diabetes outpatients,
- Older than 18 years and younger than 60,
- Non-pregnant,
- English speakers,
- Who use Medtronic insulin pumps and continuous glucose monitoring sensors,
- Own a smartphone,
- Have kept in consistent contact with the Mayo Clinic Division of Endocrinology health care team during the last year, and have use the same insulin pump and continuous glucose sensor for at least one year.
Exclusion Criteria:
- Subjects who do not satisfy the inclusion criteria.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Insulin pump followed by iDECIDE
iDECIDE followed by insulin pump
Arm Description
Participants will be randomly assigned to 4 weeks of using their insulin pump to decide insulin boluses and then 4 weeks of using iDECIDE to receive recommendations for insulin dosing.
Participants will be randomly assigned to 4 weeks of using iDECIDE to receive recommendations for insulin dosing and then 4 weeks of using their insulin pump to decide insulin boluses.
Outcomes
Primary Outcome Measures
Compare mean postprandial glucose level
Compare iDECIDE's insulin dosing algorithm against the pump calculators in terms of mean postprandial glucose level
Secondary Outcome Measures
Hypoglycemia events
% time with blood glucose < 3.9 mmol/L
Hyperglycemia events
% time with blood glucose > 8.0 mmol/L
Full Information
NCT ID
NCT02835183
First Posted
June 6, 2016
Last Updated
December 27, 2019
Sponsor
Arizona State University
Collaborators
Mayo Clinic
1. Study Identification
Unique Protocol Identification Number
NCT02835183
Brief Title
Evaluation of iDECIDE: A Smartphone App for Insulin Dosing Accounting for Alcohol and Exercise
Official Title
Prospective Evaluation of iDECIDE: A Smartphone App for Insulin Bolus Dosing
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Withdrawn
Study Start Date
January 2017 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
October 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Arizona State University
Collaborators
Mayo Clinic
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators propose a randomized cross-over study Phase 1 Clinical trial. 30 type 1 diabetes adult outpatients using insulin pumps and continuous glucose monitoring system will be recruited from the Endocrinology Clinic at the Mayo Clinic Arizona. Participants will be randomly assigned to 4 weeks of using their pump bolus wizards to decide insulin boluses and then 4 wks of using iDECIDE to receive recommendations for insulin dosing, or vice versa. The primary outcomes to compare iDECIDE's insulin dosing algorithm against the pump calculators will be: mean postprandial glucose level and number of events with excessive blood glucose highs and lows.
Detailed Description
The investigators will seek approval from Mayo Clinic and Arizona State University Institutional Review Board to recruit 30 type 1 diabetes adult outpatients using insulin pumps and continuous glucose monitoring system from the Endocrinology Clinic at Mayo Clinic Arizona. First, participants will complete a questionnaire to self-assess their confidence to count carbs from food/drinks, personal perceptions on how exercise/alcohol affect their blood glucose, and how they learned about it (e.g., trial and error, education from providers), and compensation techniques used to adjust for exercise performed/alcohol consumed (for instance, adjust for basal rate or adjust insulin boluses). Stored glucose data will be analyzed for the previous 8 weeks prior to entry to establish patient-specific upper and lower bounds for determining excessive blood glucose highs and lows. Second, participants will be randomly assigned to 4 weeks of using their pump bolus wizards to decide insulin boluses and then 4 weeks of using iDECIDE to receive recommendations for insulin dosing, or vice versa. Throughout the 8 weeks, study participants will be asked to wear a wristband heart rate accelerometer that will provide data on time and duration of exercise performed. Also, during the 8 weeks, study participants will use their glucose sensor and pump to measure blood glucose and to deliver basal insulin. During the 4 weeks when participants receive recommendations from iDECIDE, the pump's bolus calculator will be turned off so participants will receive no insulin bolus recommendations from pump. While receiving recommendations from iDECIDE, participants will use the pump to manually deliver insulin boluses and can either use the advice from iDECIDE or override it.
The primary outcomes to compare iDECIDE's insulin dosing algorithm against the pump calculators will be: mean postprandial glucose level and number of events with excessive blood glucose highs and lows. Potential secondary outcomes: mean percentage of time with low glucose level and time spent in the target glucose range.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Insulin pump followed by iDECIDE
Arm Type
Experimental
Arm Description
Participants will be randomly assigned to 4 weeks of using their insulin pump to decide insulin boluses and then 4 weeks of using iDECIDE to receive recommendations for insulin dosing.
Arm Title
iDECIDE followed by insulin pump
Arm Type
Experimental
Arm Description
Participants will be randomly assigned to 4 weeks of using iDECIDE to receive recommendations for insulin dosing and then 4 weeks of using their insulin pump to decide insulin boluses.
Intervention Type
Device
Intervention Name(s)
iDECIDE
Intervention Description
The iDECIDE app will be installed in study participant's smartphone. The app requests from study participants input on food consumed (included food's carbohydrate content), alcohol consumed (included alcohol's carbohydrate content) and exercise plans (including duration and intensity). Based on that input the app suggests insulin bolus dosing.
Intervention Type
Device
Intervention Name(s)
Insulin pump
Intervention Description
Study participants will use during the study their own insulin pump and continuous glucose sensor. As inclusion criteria, investigators expect study participants to have been using their insulin pump and continuous glucose sensor for at least one year.
Primary Outcome Measure Information:
Title
Compare mean postprandial glucose level
Description
Compare iDECIDE's insulin dosing algorithm against the pump calculators in terms of mean postprandial glucose level
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Hypoglycemia events
Description
% time with blood glucose < 3.9 mmol/L
Time Frame
2 months
Title
Hyperglycemia events
Description
% time with blood glucose > 8.0 mmol/L
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Mayo Clinic Arizona type 1 diabetes outpatients,
Older than 18 years and younger than 60,
Non-pregnant,
English speakers,
Who use Medtronic insulin pumps and continuous glucose monitoring sensors,
Own a smartphone,
Have kept in consistent contact with the Mayo Clinic Division of Endocrinology health care team during the last year, and have use the same insulin pump and continuous glucose sensor for at least one year.
Exclusion Criteria:
Subjects who do not satisfy the inclusion criteria.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of iDECIDE: A Smartphone App for Insulin Dosing Accounting for Alcohol and Exercise
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