Type 1 Diabetes Clinical Trial
— DiaboulimiaOfficial title:
Prevalence of Eating Disorders in Adult Patients With Type I Diabetes and Insulin Pump Treatment
Verified date | March 2022 |
Source | Icadom |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine the prevalence of eating disorders in type 1 insulin-dependent diabetes patients
Status | Completed |
Enrollment | 200 |
Est. completion date | December 23, 2021 |
Est. primary completion date | December 23, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | AGIR à dom. | Meylan |
Lead Sponsor | Collaborator |
---|---|
Icadom | AGIR à Dom |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Eating disorders in cohort | 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. |
at inclusion | |
Secondary | Auto declared insulin under dosage | 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. |
at inclusion | |
Secondary | Overall glycemia | 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 | at inclusion | |
Secondary | Basal/Bolus insulin ratio | 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 | at inclusion | |
Secondary | Boluses performed per day | 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 | at inclusion | |
Secondary | Body composition | 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. | at inclusion | |
Secondary | Continuous glycemic control | 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). | at inclusion | |
Secondary | Glycemic variability | 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. | at inclusion | |
Secondary | Adherence to the sensor | 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. | at inclusion | |
Secondary | Blood glucose monitoring | 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. | at inclusion |
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