Evaluation of iDECIDE: A Smartphone App for Insulin Dosing Accounting for Alcohol and Exercise

Not Applicable

Withdrawn

• Conditions: Type 1 Diabetes
• Interventions: Device: iDECIDE; Device: Insulin pump

• Registration Number: NCT02835183
• Lead Sponsor: Arizona State University

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.

Study Timeline

• Study First Submitted: 2016-06-06
• Study First Submitted QC: 2016-07-14
• Study First Posted: 2016-07-15
• Study Start: 2017-01
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-27
• Last Update Posted: 2020-01-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Insulin pump followed by iDECIDE	iDECIDE	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.
Insulin pump followed by iDECIDE	Insulin pump	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.
iDECIDE followed by insulin pump	Insulin pump	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.
iDECIDE followed by insulin pump	iDECIDE	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.

Primary Outcome Measures

Name	Time	Method
Compare mean postprandial glucose level	2 months	Compare iDECIDE's insulin dosing algorithm against the pump calculators in terms of mean postprandial glucose level

Secondary Outcome Measures

Name	Time	Method
Hyperglycemia events	2 months	% time with blood glucose \> 8.0 mmol/L
Hypoglycemia events	2 months	% time with blood glucose \< 3.9 mmol/L