Control:Diabetes Pilot Study I

NCT04158921 | Terminated

• 1 other identifier: controldiabetes01
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Insulin Treated Type 2 Diabetes Mellitus; Diabetes Mellitus, Type 1

Keywords

Diabetes Mellitus; Insulin Therapy; Glycemic Control; Hyperglycemia; Hypoglycemia; Health Education; Self-Management; Lifestyle

Outcome Measures

Primary Outcomes (1)

• The mean change in blood glucose.

  As recorded by the patient in the app.

  Measured between the first two weeks and the last two weeks of the study.

Secondary Outcomes (1)

• The change in the number of hypoglycemic episodes.

  Measured every week between the two weeks prior to the study entry and the last two weeks of study follow-up.

Study Arms (1)

The Control:Diabetes mobile app for Diabetes self-management.

OTHER

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.

Other: Control:Diabetes mobile app

Interventions

Control:Diabetes mobile app OTHER

The Control:Diabetes app will encourage patients to: a) predict their blood glucose level at a particular time point in the future (e.g. the next morning); then b) enter their actual blood glucose levels when that time (the next morning) comes; and c) enter reasons for the discrepancy between prediction and reality, if the prediction was significantly (e.g. \> 20%) different from the actual measurement. We hypothesize that by repeatedly encouraging disassembly of blood glucose changes into individual reasons (cognitive task analysis) while providing an incentive in the form of being able to more accurately predict blood glucose levels (operant conditioning), the app will prompt the patient to learn how various internal and environmental factors affect their blood glucose. They will then be able to adjust their behavior and medications to improve their blood glucose control.

The Control:Diabetes mobile app for Diabetes self-management.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Using a closed loop insulin delivery system (Medtronic 670G or OpenAPS)

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus; Hyperglycemia; Hypoglycemia; Health Education

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: November 7, 2019
• First Posted: November 12, 2019
• Study Start: November 7, 2019
• Primary Completion: July 20, 2022
• Study Completion: July 20, 2022
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)