Control:Diabetes Pilot Study I

Clinical Trial ID: NCT04158921

Description

This is a single arm open label pilot clinical trial that will assess patient-reported blood glucose levels before and after using the Control:Diabetes mobile app, while collecting user feedback and recommendations for further improvements to the app functionality and user interface. This study will enroll approximately 70 individuals with insulin-treated diabetes mellitus. The study will include two online surveys (baseline and exit), one study initiation phone call, and will also collect data entered by the users into the mobile app.

The objectives of this study are to: - Test the hypothesis that patients with diabetes mellitus treated with insulin and elevated blood glucose will achieve better glycemic control after using the Control:Diabetes mobile app. - Test the hypothesis that patients with diabetes mellitus treated with insulin and frequent hypoglycemia will achieve lower frequency of hypoglycemia after using the Control:Diabetes mobile app.


Criteria

Inclusion Criteria: - Age ≥ 18 years - Diagnosis of Type 1 Diabetes or Type 2 Diabetes - Treatment with multiple daily insulin injections (MDII) or continuous subcutaneous insulin infusion (CSII) - Baseline HbA1c between 7% and 10.5% (as reported by the participant) and/or self- reported frequency of symptomatic hypoglycemia ≥ 3 times / week - Ownership of a smartphone running either Android or iOS operating system with an active data plan Exclusion Criteria: - Using a closed loop insulin delivery system (Medtronic 670G or OpenAPS)

  • Start Date

    2019-11-07

  • Last Updated

    2019-11-07

  • Sponsor

    Brigham and Women's Hospital

  • Condition Name

    Diabetes Mellitus, Type 1

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