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

Primary Purpose

Type 1 Diabetes Mellitus, Eating Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Therapy with Mobile App Enhancement
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Eating Disorders, Diabulimia, ED-T1DM, Type 1 Diabetes, Mobile Technology, Acceptance and Commitment Therapy

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Duke University Health System
  • Duke University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Therapy with Mobile App Enhancement

Arm Description

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.

Outcomes

Primary Outcome Measures

Metabolic Control (Change in HbA1c)

Secondary Outcome Measures

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

Full Information

First Posted
July 8, 2016
Last Updated
June 7, 2019
Sponsor
Duke University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT02980627
Brief Title
iOmit: Reducing Intentional Insulin Misuse in Type 1 Diabetes
Acronym
iOmit
Official Title
iOmit: Reducing Intentional Insulin Misuse in Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
May 2, 2019 (Actual)
Study Completion Date
May 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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..

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus, Eating Disorders
Keywords
Eating Disorders, Diabulimia, ED-T1DM, Type 1 Diabetes, Mobile Technology, Acceptance and Commitment Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Therapy with Mobile App Enhancement
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Therapy with Mobile App Enhancement
Other Intervention Name(s)
Recovery Record, Acceptance and Commitment Therapy, ACT, Mobile Technology
Intervention Description
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.
Primary Outcome Measure Information:
Title
Metabolic Control (Change in HbA1c)
Time Frame
Baseline, 3-months, 6-months and 9-months
Secondary Outcome Measure Information:
Title
Mobile Technology Engagement (Frequency of Use)
Description
Improvements in metabolic control will correspond with treatment engagement as reflected in frequency of app use from 0-3 months
Time Frame
Daily monitoring for 3 months
Title
Adequate Insulin Dosing (Frequency)
Description
Participants will report less frequent under-dosing of insulin
Time Frame
Baseline, 3-months, 6-months and 9-months
Title
Medical Utilization: Total Number of Primary Care Visits
Time Frame
Baseline, 3-months, 6-months, and 9-months
Title
Medical Utilization: Total Number of Emergency Department Care Visits
Time Frame
Baseline, 3-months, 6-months, and 9-months
Title
Participant Engagement in Treatment as evidenced by attendance/treatment completion
Description
Attrition will be < 20%
Time Frame
3 months
Title
Improvement in Metabolic Control; CGM Continuous Glucose Monitoring
Time Frame
Baseline, 3-months
Title
Decrease in Diabetes-Specific Eating Disorder symptomatology
Time Frame
Baseline, 3-months, 6-months, and 9-months
Title
Decrease in Overall Eating Disorder symptomatology
Time Frame
Baseline, 3-months, 6-months, and 9-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult aged 18 or older Diagnosed with T1D Positive for insulin misuse for weight control HbA1c ≥ 7.5 Approved for participation by their physician Agrees to continue care with their current physician with consent to contact Access to a Smartphone Exclusion Criteria: Non-English speaking Cognitive impairments that preclude independent management of T1D
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rhonda Merwin, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Health System
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27713
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26384389
Citation
Merwin RM, Dmitrieva NO, Honeycutt LK, Moskovich AA, Lane JD, Zucker NL, Surwit RS, Feinglos M, Kuo J. Momentary Predictors of Insulin Restriction Among Adults With Type 1 Diabetes and Eating Disorder Symptomatology. Diabetes Care. 2015 Nov;38(11):2025-32. doi: 10.2337/dc15-0753. Epub 2015 Sep 17.
Results Reference
background
PubMed Identifier
24882448
Citation
Merwin RM, Moskovich AA, Dmitrieva NO, Pieper CF, Honeycutt LK, Zucker NL, Surwit RS, Buhi L. Disinhibited eating and weight-related insulin mismanagement among individuals with type 1 diabetes. Appetite. 2014 Oct;81:123-30. doi: 10.1016/j.appet.2014.05.028. Epub 2014 May 29.
Results Reference
background
PubMed Identifier
33407910
Citation
Merwin RM, Moskovich AA, Babyak M, Feinglos M, Honeycutt LK, Mooney J, Freeman SP, Batchelder H, Sangvai D. An open trial of app-assisted acceptance and commitment therapy (iACT) for eating disorders in type 1 diabetes. J Eat Disord. 2021 Jan 6;9(1):6. doi: 10.1186/s40337-020-00357-6.
Results Reference
derived
Links:
URL
http://www.ACTatDuke.org
Description
Acceptance and Commitment Therapy at Duke University Medical Center

Learn more about this trial

iOmit: Reducing Intentional Insulin Misuse in Type 1 Diabetes

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