iOmit: Reducing Intentional Insulin Misuse in Type 1 Diabetes (iOmit)

June 7, 2019 updated by: Duke University

Individuals with type 1 diabetes who intentionally omit insulin to lose weight are at high risk for diabetes-related medical complications and premature death. Conventional eating disorder (ED) treatments are not as effective for these patients, suggesting that they need a more tailored treatment approach and one that includes intervention at the time and place when they are making decisions about their diabetes self-management. The goal of treatment development project is to modify an existing mobile application (app) for EDs (Recovery Record; RR) to address the unique needs of adults with type 1 diabetes (T1D) who intentionally omit their insulin for weight control, and test whether app-supported individual treatment decreases eating disorder (ED) symptoms and improves metabolic control. The investigator will also gather preliminary data on the impact of the intervention on health care utilization and costs and calculate attrition to assess feasibility.

The investigators hypothesize that (1) participants will evidence significant decreases in mean blood glucose, (2) participation in routine medical care will increase and emergency visits will decrease, (3) the percentage of time participants are hyperglycemic will decrease, (4) participant scores on the DEPS-R will decrease and (5) participant scores on the EDE will decrease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Intentional insulin omission for weight control is a significant problem in the clinical management of type 1 diabetes (T1D); despite this, there are no effective treatments. Combining the use of mobile technology with individual therapy may help individuals with T1D identify their triggers for insulin omission in their natural environment and cope more effectively. In the current study, the investigators examine whether pairing a mobile application, Recovery Record, with individual therapy helps reduce intentional insulin omission for weight control among individuals with T1D. In Phase 1, the investigators build T1D-specific content into the Recovery Record app based on our empirical evidence of triggers for insulin omission and qualitative feedback from T1D patients. The fully functional app is beta tested with 10 T1D patients who intentionally omit insulin. In Phase 2, 25 T1D patients that misuse insulin complete 3 months of app-supported individual treatment and 6 months of follow-up. The investigators test whether treatment is associated with decreases in mean blood glucose, eating disorder symptoms and emergency care utilization. The investigators also test whether frequency of app use in months 0-3 corresponds with outcomes, and calculate attrition..

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Health System
      • Durham, North Carolina, United States, 27713
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Adult aged 18 or older
  2. Diagnosed with T1D
  3. Positive for insulin misuse for weight control
  4. HbA1c ≥ 7.5
  5. Approved for participation by their physician
  6. Agrees to continue care with their current physician with consent to contact
  7. Access to a Smartphone

Exclusion Criteria:

  1. Non-English speaking
  2. Cognitive impairments that preclude independent management of T1D

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Therapy with Mobile App Enhancement
Participants will complete initial assessments and then take part in a 3-month intervention consisting of 12 weekly individual therapy sessions with daily RR app use between sessions. At the end of the 3-month intervention period, an exit interview will be conducted and participants will complete a second assessment consisting of questionnaires and an ED diagnostic interview, a blood specimen for HbA1c, and 3-days of blinded CGM monitoring. Participants will then enter a 6-month follow-up period during which time they may continue to use the app, but will no longer attend individual sessions. Participants will be return to the clinic at 6 and 9 months for follow-up.
Behavioral: Therapy with Mobile App Enhancement
Treatment includes 12 weekly therapy sessions with daily RR app use between sessions. Intervention is CBT-based and specifically draws from ACT. ACT is a contextual behavior therapy that emphasizes the function of behavior (e.g., affect regulation) and helps individuals accept (or "tolerate") emotional discomfort for a broader purpose (i.e., personal values). Broadly, treatment will focus on improving diabetes management by increasing patients' capacity to effectively cope with psychological barriers to self-care using acceptance and mindfulness strategies.
Other Names:
  • ACT
  • Recovery Record
  • Acceptance and Commitment Therapy
  • Mobile Technology

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Metabolic Control (Change in HbA1c)
Time Frame: Baseline, 3-months, 6-months and 9-months
Baseline, 3-months, 6-months and 9-months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mobile Technology Engagement (Frequency of Use)
Time Frame: Daily monitoring for 3 months
Improvements in metabolic control will correspond with treatment engagement as reflected in frequency of app use from 0-3 months
Daily monitoring for 3 months
Adequate Insulin Dosing (Frequency)
Time Frame: Baseline, 3-months, 6-months and 9-months
Participants will report less frequent under-dosing of insulin
Baseline, 3-months, 6-months and 9-months
Medical Utilization: Total Number of Primary Care Visits
Time Frame: Baseline, 3-months, 6-months, and 9-months
Baseline, 3-months, 6-months, and 9-months
Medical Utilization: Total Number of Emergency Department Care Visits
Time Frame: Baseline, 3-months, 6-months, and 9-months
Baseline, 3-months, 6-months, and 9-months
Participant Engagement in Treatment as evidenced by attendance/treatment completion
Time Frame: 3 months
Attrition will be < 20%
3 months
Improvement in Metabolic Control; CGM Continuous Glucose Monitoring
Time Frame: Baseline, 3-months
Baseline, 3-months
Decrease in Diabetes-Specific Eating Disorder symptomatology
Time Frame: Baseline, 3-months, 6-months, and 9-months
Baseline, 3-months, 6-months, and 9-months
Decrease in Overall Eating Disorder symptomatology
Time Frame: Baseline, 3-months, 6-months, and 9-months
Baseline, 3-months, 6-months, and 9-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Rhonda Merwin, PhD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

May 2, 2019

Study Completion (Actual)

May 2, 2019

Study Registration Dates

First Submitted

July 8, 2016

First Submitted That Met QC Criteria

November 30, 2016

First Posted (Estimate)

December 2, 2016

Study Record Updates

Last Update Posted (Actual)

June 11, 2019

Last Update Submitted That Met QC Criteria

June 7, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00068040
  • 1R21DK106603-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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