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Insulin Omission Surrogate (iOS)

NCT05476861 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 751

Last updated 2023-05-12

No results posted yet for this study

Summary

Type 1 Diabetes management is requiring and implies numerous lifestyle modifications. Insulin restriction to control weight is a frequent phenomenon, affecting up to 40% of PWT1D. Broadly, purging or binge eating behaviors are also frequently disordered eating behaviors (DEB) in people living with a Type 1 Diabetes (associated or not with restrictive eating behaviors). In a study on adolescents with T1D, the prevalence of moderate or high level of DEB ranged from 21% to 32%. Moreover, the presence of binge eating behavior seems to be associated with higher anxiety and depression levels.

Omitting insulin for weight control has been associated with the highest rates of retinopathy and nephropathy when compared to other weight control behaviors and to increase the risk of mortality by 3.2 times and decrease life spans from an average of 58 to 44 years at 11-year follow-up. Moreover, insulin misuse may be much more complex behavior than just the need for weight control. These behaviors may also involve increased distress, loss of control, and feelings of regret, guilt, and shame.

Interestingly, most studies of eating disorders and type 1 diabetes use question regarding insulin omission as a surrogate marker for eating disorders and disordered eating. For instance, the question used in the BETTER registry are: "In the past 12 months, did you intentionally omit insulin injections with the objective of losing weight?" or "In a typical week, how often do you miss an insulin dose?". However, the validity and robustness of such a marker have not been specifically investigated yet.

Our study objectives are : 1) To confirm that participants who reported intentionally omitting insulin had significantly more disordered eating behavior (based on the review of food records available); 2) To compare the prevalence and the severity of physical and mental health comorbidities (e.g., diabetes micro and macrovascular complications, glycated hemoglobin levels, current and past psychiatric disorders, distress related to diabetes) in people living with diabetes having or not declared to intentionally omit insulin; 3) To establish, using machine learning techniques, the main factors associated with intentional insulin omission behavior, taking into account biological, anthropometric and psychometric factors.

Conditions

Sponsors & Collaborators

  • McGill University

    collaborator OTHER

  • Institut de Recherches Cliniques de Montreal

    collaborator OTHER

  • Laval University

    lead OTHER

Principal Investigators

  • Sylvain Iceta, MD, PhD · Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2023-05-10
Completion
2023-05-10

Countries

  • Canada

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05476861 on ClinicalTrials.gov