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Completed

NCT Number: NCT04506216

Eating Disorders in Type 1 Insulin-dependent Diabetes Patients

The purpose of this study is to determine the prevalence of eating disorders in type 1 insulin-dependent diabetes patients

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Key information

About this study

The risk of developing an eating disorder is increased in type 1 diabetes patients and associated with a poor prognosis in terms of glycemic control, metabolic complications, degenerative complications, and mortality.

Therefore the terminology diaboulimia has emerged to characterize an eating disorder specific to type 1 insulin-dependent diabetes patients, with insulin under dosage with a view of losing or controlling weight and that can contribute to a deterioration of the body composition.

The purpose of this study is to determine the prevalence of eating disorders in an adult cohort with type 1 insulin-dependent diabetes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patient over 18 years of age with type 1 diabetes treated with a subcutaneous insulin pump
  • Patient followed up for a subcutaneous insulin pump treatment by the healthcare provider, participating in the study (Agir à Dom group).
  • Beneficiary of social security coverage.

Exclusion criteria

  • Patient with type 2 diabetes or MODY diabetes
  • Patient wearing a pacemaker
  • Breastfeeding or pregnant woman
  • Deprived of liberty by judicial or administrative decision
  • Legal guardianship

Treatment and study plan

Cohort

Other

During a regular follow-up visit, the following data will be collected:

  • questionnaires on lifestyle, eating custom (SCOFF-F, 5th question of the m-SCOFF) and physical activity (IPAQ)
  • bio-electric impedance analysis
  • insulin pump and sensor data collection

Primary outcomes

  1. Eating disorders in men and women

    Time frame: at inclusion

    To determine eating disorder prevalence in differentiated adult men and women with type 1 insulin-dependent diabetes.

    Patients answer to the SCOFF-F questions :

    • do you make yourself sick because you feel uncomfortably full?
    • do you worry that you have lost control over how much you eat?
    • have you recently lost more than one stone in a 3 month period?
    • do you believe yourself to be fat when others say you are too thin?
    • would you say that food dominates your life?

    Every "yes" attributes one point and gives a final score between 0 and 5; a score ≥2 indicates an eating disorder.

Secondary outcomes

  1. Eating disorders in cohort

    Time frame: at inclusion

    To determine eating disorder prevalence in undifferentiated cohort (men and woman) with type 1 insulin-dependent diabetes.

    Patients answer to the SCOFF-F questions :

    • do you make yourself sick because you feel uncomfortably full?
    • do you worry that you have lost control over how much you eat?
    • have you recently lost more than one stone in a 3 month period?
    • do you believe yourself to be fat when others say you are too thin?
    • would you say that food dominates your life?

    Every "yes" attributes one point and gives a final score between 0 and 5; a score ≥2 indicates an eating disorder.

  2. Auto declared insulin under dosage

    Time frame: at inclusion

    To Determine the auto declared insulin under dosage prevalence in undifferentiated cohort (men and woman) with type 1 insulin-dependent diabetes.

    Patients answer to the 5th m-SCOFF question :

    • do you ever take less insulin than you should?

    A "yes" answer means that patient underdoses insulin treatment.

  3. Overall glycemia

    Time frame: at inclusion

    To identify if there is a link between an eating disorder and overall glycemic control, we will look after the last biological value of HbA1c rates

  4. Basal/Bolus insulin ratio

    Time frame: at inclusion

    To identify if there is a link between an eating disorder and basal/bolus insulin ratio, we will extract and compare to eating disorder presence, this daily data from insulin pump over the 14 days preceding inclusion

  5. Boluses performed per day

    Time frame: at inclusion

    To identify if there is a link between an eating disorder and boluses performed per day, we will extract and compare to eating disorder presence, this daily data from insulin pump over the 14 days preceding inclusion

  6. Body composition

    Time frame: at inclusion

    To identify if there is a link between an eating disorder and body composition, we will perform a bio-electric impedance analysis and compare the result to eating disorder presence.

  7. Continuous glycemic control

    Time frame: at inclusion

    To identify if there is a link between an eating disorder and continuous glycemic control, we will extract and compare to eating disorder presence, this data from the continuous glucose monitoring system (CGMS) over the 14 days preceding inclusion Glycemic control will be determined by the percentage of daily time into the glycemic target (between 70 and 180 mg/dL).

  8. Glycemic variability

    Time frame: at inclusion

    To identify if there is a link between an eating disorder and glycemic variability, we will extract and compare to eating disorder presence, this data from the continuous glucose monitoring system (CGMS) over the 14 days preceding inclusion Glycemic variability will be determined by the Mean Amplitude of Glycemic Excursions (MAGE) algorithm.

  9. Adherence to the sensor

    Time frame: at inclusion

    To identify if there is a link between an eating disorder and the adherence to the continuous glucose monitoring system (CGMS), we will extract and compare to eating disorder presence, this data from the continuous glucose monitoring system (CGMS) over the 14 days preceding inclusion Adherence will be determined by the number of minutes worn per day.

  10. Blood glucose monitoring

    Time frame: at inclusion

    To identify if there is a link between an eating disorder and blood glucose monitoring, we will extract and compare to eating disorder presence, this data from the continuous glucose monitoring system (CGMS) over the 14 days preceding inclusion The monitoring will be determined by the number of scans done per day.

Sponsors and collaborators

Lead sponsor

Icadom

Industry

Collaborators

  • AGIR à Dom

Registry information

Official study title

Prevalence of Eating Disorders in Adult Patients With Type I Diabetes and Insulin Pump Treatment

Acronym: Diaboulimia

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 10, 2020
Registry last updated
Apr 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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