Type 1 DiabetesDiaboulimiaNCT04506216
Eating Disorders in Type 1 Insulin-dependent Diabetes Patients
A study testing cohort in people with Type 1 Diabetes and Eating Disorders, run by Icadom at 1 site in France.
Trial summary
The purpose of this study is to determine the prevalence of eating disorders in type 1 insulin-dependent diabetes patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes, Eating Disorders
- What is being tested?
- cohort
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2020to 23 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Eating Disorders in Adult Patients With Type I Diabetes and Insulin Pump Treatment
The purpose of this study is to determine the prevalence of eating disorders in type 1 insulin-dependent diabetes patients
Read the 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.
- Conditions
- Type 1 Diabetes, Eating Disorders
- Being tested
- cohort
- Keywords
- diaboulimia, insulin pump treatment, DT1
- Medical subject headings
- Diabetes Mellitus, Type 1, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cohortOther
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
| Study group | Role | What they receive |
|---|---|---|
| cohort | Experimental | adult patients with type 1 diabetes and insulin pump treatment . Duration of participation: 30 minutes Receives: Other: cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at inclusion
Secondary outcomes (10)
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.
Measured: at inclusion
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.
Measured: at inclusion
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
Measured: at inclusion
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
Measured: at inclusion
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
Measured: at inclusion
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.
Measured: at inclusion
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).
Measured: at inclusion
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.
Measured: at inclusion
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.
Measured: at inclusion
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.
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start1 Sep 2020
- Primary completion23 Dec 2021
- Study completion23 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- cohort prospective monocentric
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icadom
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AGIR à Dom
- Responsible party
- Sponsor
- Investigators
- Cécile Bétry, PhD, Principal investigator, CHU Grenoble Alpes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04506216
- Sponsor's protocol ID
- 2020-A00147-32
- Acronym
- Diaboulimia
- Status last verified
- Mar 2022
- First submitted
- 5 Aug 2020
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Contact icadom@agiradom.com for any data request. The researcher will be invited to complete a form (data sharing agreement) explaining the reasons and the aim of the data requests. The data will be de-identified.
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Eating Disorders in Adult Patients With Type I Diabetes and Insulin Pump Treatment
- ClinicalTrials.gov ID
- NCT04506216
- Acronym / sponsor ID
- Diaboulimia / 2020-A00147-32
- Conditions
- Type 1 Diabetes, Eating Disorders
- Keywords
- diaboulimia, insulin pump treatment, DT1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- IcadomIndustry (pharma, biotech, devices)
- Collaborators
- AGIR à Dom
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 23 Dec 2021 (actual)
- Study completion
- 23 Dec 2021 (actual)
- First posted
- 10 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- cohort prospective monocentric
| Arm | Type | Receives |
|---|---|---|
| cohort | Experimental | Other: cohortadult patients with type 1 diabetes and insulin pump treatment . Duration of participation: 30 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cohortDuring 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 | Other | cohort |
Primary outcome
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.
10 secondary outcomes
Eating disorders in cohort
Time frame: at inclusion
Auto declared insulin under dosage
Time frame: at inclusion
Overall glycemia
Time frame: at inclusion
Basal/Bolus insulin ratio
Time frame: at inclusion
Boluses performed per day
Time frame: at inclusion
Body composition
Time frame: at inclusion
Continuous glycemic control
Time frame: at inclusion
Glycemic variability
Time frame: at inclusion
Adherence to the sensor
Time frame: at inclusion
Blood glucose monitoring
Time frame: at inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
- Individual participant dataSharing planned: Yes. Contact icadom@agiradom.com for any data request. The researcher will be invited to complete a form (data sharing agreement) explaining the reasons and the aim of the data requests. The data will be de-identified.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cécile Bétry, PhD principal investigator
CHU Grenoble Alpes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cohort in people with Type 1 Diabetes and Eating Disorders, run by Icadom at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eating disorders in men and women (time frame: at inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2022.