Eating Disorders in Type 1 Insulin-dependent Diabetes Patients

NCT04506216 | Completed DMC

• 1 other identifier: 2020-A00147-32
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type 1 Diabetes; Eating Disorders

Keywords

diaboulimia; insulin pump treatment; DT1

Outcome Measures

Primary Outcomes (1)

• Eating disorders in men and women

  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.

  at inclusion

Secondary Outcomes (10)

• Eating disorders in cohort

  at inclusion

• Auto declared insulin under dosage

  at inclusion

• Overall glycemia

  at inclusion

• Basal/Bolus insulin ratio

  at inclusion

• Boluses performed per day

  at inclusion

Study Arms (1)

cohort

EXPERIMENTAL

adult patients with type 1 diabetes and insulin pump treatment . Duration of participation: 30 minutes

Other: cohort

Interventions

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

cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Icadom: lead
• AGIR à Dom: collaborator

Study Sites (1)

AGIR à dom.

Meylan, 38240, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Feeding and Eating Disorders

Interventions

Cohort Studies

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Cécile Bétry, PhD

  CHU Grenoble Alpes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: cohort prospective monocentric

Study Record Dates

• First Submitted: August 5, 2020
• First Posted: August 10, 2020
• Study Start: September 1, 2020
• Primary Completion: December 23, 2021
• Study Completion: December 23, 2021
• Last Updated: April 8, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: January 2022 to January 2037
• Access Criteria: Researchers requesting the data have to be able to present a scientific reason to get access

Locations

FR (1)