iOmit: Reducing Intentional Insulin Misuse in Type 1 Diabetes (iOmit)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02980627|
Recruitment Status : Active, not recruiting
First Posted : December 2, 2016
Last Update Posted : September 12, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus Eating Disorders||Behavioral: Therapy with Mobile App Enhancement Device: Recovery Record (RR) Mobile app||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||iOmit: Reducing Intentional Insulin Misuse in Type 1 Diabetes|
|Actual Study Start Date :||March 2016|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||June 2019|
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.
Device: Recovery Record (RR) Mobile app
Treatment includes the use of a mobile application originally designed for eating disorders and adapted to include components specific to Type 1 Diabetes and Acceptance and Commitment Therapy (ACT). Participants will access this app outside of therapy and receive prompts from their therapist related to their current treatment goals.
- Metabolic Control (Change in HbA1c) [ Time Frame: Baseline, 3-months, 6-months and 9-months ]
- 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
- Adequate Insulin Dosing (Frequency) [ Time Frame: Baseline, 3-months, 6-months and 9-months ]Participants will report less frequent under-dosing of insulin
- Medical Utilization: Total Number of Primary Care Visits [ Time Frame: 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 ]
- Participant Engagement in Treatment as evidenced by attendance/treatment completion [ Time Frame: 3 months ]Attrition will be < 20%
- Improvement in Metabolic Control; CGM Continuous Glucose Monitoring [ Time Frame: Baseline, 3-months ]
- Decrease in Diabetes-Specific Eating Disorder symptomatology [ Time Frame: Baseline, 3-months, 6-months, and 9-months ]
- Decrease in Overall Eating Disorder symptomatology [ Time Frame: Baseline, 3-months, 6-months, and 9-months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02980627
|United States, North Carolina|
|Duke University Health System|
|Durham, North Carolina, United States, 27710|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27713|
|Principal Investigator:||Rhonda Merwin, PhD||Duke University|