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Eating Disorders in Type 1 Insulin-dependent Diabetes Patients

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04506216
Acronym
Diaboulimia
Enrollment
200
Registered
2020-08-10
Start date
2020-09-01
Completion date
2021-12-23
Last updated
2022-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eating Disorders, Type 1 Diabetes

Keywords

diaboulimia, insulin pump treatment, DT1

Brief summary

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

Detailed description

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.

Interventions

OTHERcohort

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

Sponsors

AGIR à Dom
CollaboratorOTHER
Icadom
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

cohort prospective monocentric

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Eating disorders in men and womenat inclusionTo 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

MeasureTime frameDescription
Auto declared insulin under dosageat inclusionTo 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.
Overall glycemiaat inclusionTo 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
Basal/Bolus insulin ratioat inclusionTo 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
Boluses performed per dayat inclusionTo 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
Eating disorders in cohortat inclusionTo 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.
Continuous glycemic controlat inclusionTo 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).
Glycemic variabilityat inclusionTo 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.
Adherence to the sensorat inclusionTo 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.
Blood glucose monitoringat inclusionTo 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.
Body compositionat inclusionTo 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026