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Type 1 Diabetes MellitusiOmitNCT02980627

iOmit: Reducing Intentional Insulin Misuse in Type 1 Diabetes

A study testing Therapy with Mobile App Enhancement in people with Type 1 Diabetes Mellitus and Eating Disorders, run by Duke University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Type 1 Diabetes Mellitus, Eating Disorders
What is being tested?
Therapy with Mobile App Enhancement
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
2 sitesUnited States
Study dates
Mar 2016to 2 May 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • Non-English speaking
  • Cognitive impairments that preclude independent management of T1D

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Duke University Health System

    Durham, North Carolina, 27710

  • Duke University Medical Center

    Durham, North Carolina, 27713

Other trials in United States

About this study

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.

Read the 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..

Being tested
Therapy with Mobile App Enhancement
Keywords
Eating Disorders, Diabulimia, ED-T1DM, Type 1 Diabetes, Mobile Technology, Acceptance and Commitment Therapy
Medical subject headings
Diabetes Mellitus, Type 1, Feeding and Eating Disorders, Diabulimia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Therapy with Mobile App EnhancementBehavioural

    Also called Recovery Record, Acceptance and Commitment Therapy, ACT, Mobile Technology

    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.

Study groups in NCT02980627
Study groupRoleWhat they receive
Therapy with Mobile App EnhancementExperimentalParticipants 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.
Receives: Behavioral: Therapy with Mobile App Enhancement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Metabolic Control (Change in HbA1c)

    Measured: Baseline, 3-months, 6-months and 9-months

Secondary outcomes (8)

  1. 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

    Measured: Daily monitoring for 3 months

  2. Adequate Insulin Dosing (Frequency)

    Participants will report less frequent under-dosing of insulin

    Measured: Baseline, 3-months, 6-months and 9-months

  3. Medical Utilization: Total Number of Primary Care Visits

    Measured: Baseline, 3-months, 6-months, and 9-months

  4. Medical Utilization: Total Number of Emergency Department Care Visits

    Measured: Baseline, 3-months, 6-months, and 9-months

  5. Participant Engagement in Treatment as evidenced by attendance/treatment completion

    Attrition will be < 20%

    Measured: 3 months

  6. Improvement in Metabolic Control; CGM Continuous Glucose Monitoring

    Measured: Baseline, 3-months

  7. Decrease in Diabetes-Specific Eating Disorder symptomatology

    Measured: Baseline, 3-months, 6-months, and 9-months

  8. Decrease in Overall Eating Disorder symptomatology

    Measured: Baseline, 3-months, 6-months, and 9-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2016 (estimated)
  2. Study startMar 2016
  3. Primary completion2 May 2019
  4. Study completion2 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02980627
Sponsor's protocol ID
Pro00068040
Other IDs
1R21DK106603-01A1
Acronym
iOmit
Status last verified
Apr 2019
First submitted
8 Jul 2016
Last updated
11 Jun 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26384389

  • 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.

    PubMed 24882448

  • 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.

    PubMed 33407910

Questions about this trial

What is this clinical trial studying?

A study testing Therapy with Mobile App Enhancement in people with Type 1 Diabetes Mellitus and Eating Disorders, run by Duke University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Metabolic Control (Change in HbA1c) (time frame: Baseline, 3-months, 6-months and 9-months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02980627, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2019.

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