iOmit: Reducing Intentional Insulin Misuse in Type 1 Diabetes (iOmit)
7. juni 2019 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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..
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
27
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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North Carolina
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Durham, North Carolina, Forenede Stater, 27710
- Duke University Health System
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Durham, North Carolina, Forenede Stater, 27713
- Duke University Medical Center
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 55 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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.
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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.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Metabolic Control (Change in HbA1c)
Tidsramme: Baseline, 3-months, 6-months and 9-months
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Baseline, 3-months, 6-months and 9-months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Mobile Technology Engagement (Frequency of Use)
Tidsramme: Daily monitoring for 3 months
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Improvements in metabolic control will correspond with treatment engagement as reflected in frequency of app use from 0-3 months
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Daily monitoring for 3 months
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Adequate Insulin Dosing (Frequency)
Tidsramme: Baseline, 3-months, 6-months and 9-months
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Participants will report less frequent under-dosing of insulin
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Baseline, 3-months, 6-months and 9-months
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Medical Utilization: Total Number of Primary Care Visits
Tidsramme: Baseline, 3-months, 6-months, and 9-months
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Baseline, 3-months, 6-months, and 9-months
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Medical Utilization: Total Number of Emergency Department Care Visits
Tidsramme: Baseline, 3-months, 6-months, and 9-months
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Baseline, 3-months, 6-months, and 9-months
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Participant Engagement in Treatment as evidenced by attendance/treatment completion
Tidsramme: 3 months
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Attrition will be < 20%
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3 months
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Improvement in Metabolic Control; CGM Continuous Glucose Monitoring
Tidsramme: Baseline, 3-months
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Baseline, 3-months
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Decrease in Diabetes-Specific Eating Disorder symptomatology
Tidsramme: Baseline, 3-months, 6-months, and 9-months
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Baseline, 3-months, 6-months, and 9-months
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Decrease in Overall Eating Disorder symptomatology
Tidsramme: Baseline, 3-months, 6-months, and 9-months
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Baseline, 3-months, 6-months, and 9-months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Rhonda Merwin, PhD, Duke University
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- 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.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. marts 2016
Primær færdiggørelse (Faktiske)
2. maj 2019
Studieafslutning (Faktiske)
2. maj 2019
Datoer for studieregistrering
Først indsendt
8. juli 2016
Først indsendt, der opfyldte QC-kriterier
30. november 2016
Først opslået (Skøn)
2. december 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
11. juni 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. juni 2019
Sidst verificeret
1. april 2019
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Pro00068040
- 1R21DK106603-01A1 (U.S. NIH-bevilling/kontrakt)
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