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

NCT02835183 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2020-01-02

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

iDECIDE

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.

DEVICE

Insulin pump

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.

Sponsors & Collaborators

  • Mayo Clinic

    collaborator OTHER

  • Arizona State University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2017-10-31
Completion
2017-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02835183 on ClinicalTrials.gov