Diabete Type 1CALI-BFNCT07151924
Eating Disturbances in Patients With Type 1 Diabetes Initiating Insulin Therapy
An observational study of Diabete Type 1, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The prevalence of eating disorders is particularly high among people with type 1 diabetes (T1D). These abnormalities, such as "diabulimia," are frequently responsible for poor insulin therapy management and, consequently, chronic glycemic imbalance, exposing them to an increased risk of complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabete Type 1
- What is being tested?
- Questionnaires answers and Biological assessment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 4 Sep 2025to 28 Feb 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: patients with type 1 diabetes for whom closed-loop insulin therapy has been recommended
Who may be able to join
- Patient diagnosed with type 1 diabetes.
- Patient with a CGM device for more than 3 months with > 80% of data captured in the last month.
- Indication for the implementation of a BF device as part of routine care, in the Diabetology, Metabolic Diseases and Nutrition Department of the Toulouse University Hospital (initiating center).
Who cannot join
- Pregnant or breastfeeding women, or those planning to become pregnant within 6 months of inclusion.
- History of obesity surgery or a preparatory program for obesity surgery planned during the study period.
- Pharmacological treatment likely to significantly influence food intake and body weight, whether ongoing or discontinued within the last 3 months (e.g., GLP-1R agonist): Liraglutide (Victoza®, Saxenda®), Semaglutide (Ozempic®, Wegovy®), Dulaglutide (Trulicity®), Tirzepatde (Mounjaro®), Orlistat (Xenical®)
- Eating disorder requiring specific treatment in the previous 12 months.
- Refusal or inability to consent to participate.
- Persons under legal protection (guardianship, curatorship, or court-ordered protection).
Trial locations and contacts
1 site in 1 country.
France1 site
Diabetology, Metabolic Diseases and Nutrition Department Rangueil Hospital, Toulouse University Hospital 1 avenue du Pr Jean Poulhès
Toulouse, 31059
About this study
Official title: Eating Disturbances in Patients With Type 1 Diabetes Initiating Closed-loop Insulin Therapy: Prevalence and Influence on Glycemic Control
The prevalence of eating disorders is particularly high among people with type 1 diabetes (T1D). These abnormalities, such as "diabulimia," are frequently responsible for poor insulin therapy management and, consequently, chronic glycemic imbalance, exposing them to an increased risk of complications. Their detection and management unfortunately remain insufficient in current practice.
However, to date, no study has addressed the question of the prevalence and impact of eating disorders in this context. Our research hypotheses are therefore as follows:
Read more
- The existence of an eating disorder is likely frequently overlooked and, therefore, not taken into account in patients with T1D initiating semi-automated insulin therapy with BF.
- The existence of an eating disorder could impair the performance of the BF device in terms of improving glycemic control in patients with T1D initiating this treatment method.
Patients clinical characteristics, glycemic monitoring parameters ad questionnaires answers will be recorded. The prevalence of eating disorders will be calculated, and the association between the presence of these abnormalities and baseline clinical characteristics and glycemic control parameters will be analyzed.
Read the detailed description
The prevalence of eating disorders (EDs) and problematic eating behaviors (PEBs) is particularly high among people with type 1 diabetes (T1D), affecting 20 to 50% of women and 5 to 25% of men among young patients. These abnormalities, such as "diabulimia," are frequently responsible for poor insulin therapy management and, consequently, chronic glycemic imbalance, exposing them to an increased risk of complications. Their detection and management unfortunately remain insufficient in current practice.
The treatment of T1D is currently undergoing a veritable technological revolution linked to the arrival of the first semi-automated insulin therapy devices (or closed loop, LF). The use of these devices most often makes it possible to achieve recommended glycemic control targets (HbA1c, continuous glucose monitoring [CGM] data), reduce glycemic variability, and avoid hypoglycemia. Insulin administration is based on the data transmitted: food intake and quantity of carbohydrates consumed. The role of dietitians is therefore crucial in the therapeutic education of patients and the care pathway imposed by the initiation of this new treatment method. It is likely that many patients initiating automated insulin therapy with BF present an eating disorder or CAP that may interfere with the management of the device.
However, to date, no study has addressed the question of the prevalence and impact of eating disorders and CAP in this context. In the absence of available data, national and international recommendation texts dedicated to insulin therapy with BF do not specify appropriate conduct for patients presenting with these eating disorders. Our research hypotheses are therefore as follows:
- The existence of an eating disorder (ED and/or CAP) is likely frequently overlooked and, therefore, not taken into account in patients with T1D initiating semi-automated insulin therapy with BF.
- The existence of an eating disorder (ED and/or CAP) could impair the performance of the BF device in terms of improving glycemic control in patients with T1D initiating this treatment method.
Patients clinical characteristics and glycemic monitoring parameters (HbA1c and CGM data), available as part of routine care, will be recorded in an electronic case report (REDCap software). The mSCOFF and QACD questionnaires will be administered during the dietary interview preceding BF device implantation, and responses will be collected. The prevalence of eating disorders will be calculated, and the association between the presence of these abnormalities and baseline clinical characteristics and glycemic control parameters will be analyzed.
The care pathway established for initiating BF treatment requires a follow-up medical consultation at 3 months, followed by a consultation at 6 months. As part of the study, visits at 3 months (12 ± 2 weeks) and 6 months (24 ± 4 weeks) will be scheduled and will include an interview with a dietitian, to collect glycemic control parameters (at 3 and 6 months), measure body weight (at 3 and 6 months), and repeat the mSCOFF and QACD questionnaires (at 6 months). Data on the evolution of glycemic control and variability parameters, weight and mSCOFF and QACD scores will be analyzed in the overall study population, then according to the existence or not of disturbances in eating behavior at inclusion.
- Conditions
- Diabete Type 1
- Being tested
- Questionnaires answers, Biological assessment
- Keywords
- diabete type 1, eating disorders, eating, insulin, insulin therapy
- Medical subject headings
- Feeding and Eating Disorders, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires answersOther
Patients will be asked to complete the MScoff and QACD questionnaires during interviews with the dietitian at baseline, 3 months and 6 months.
Biological assessmentOther
Collection of HbA1c level and continuous glucose monitoring data
| Study group | Role | What they receive |
|---|---|---|
| Patients with type 1 diabete | Patients with type 1 diabete with closed-loop therapy Receives: Other: Questionnaires answers; Other: Biological assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of eating disorders
The primary outcome measure for establishing the prevalence of eating disorders is a composite outcome measure based on determining the existence of eating disorders [ED] by analyzing responses to the mSCOFF questionnaire (score ≥ 2) and/or problematic eating behaviors [PEB] by analyzing responses to the QACD questionnaire (score ≥ 20).
Measured: 6 months after the inclusion
Secondary outcomes (14)
Prevalence of eating disorders (EDs)
Prevalence of EDs (mSCOFF score ≥ 2 and QACD ≥ 20)
Measured: 6 months after the inclusion
Clinical characteristics at inclusion
Measurement of clinical characteristics at inclusion: age
Measured: 6 months after the inclusion
Clinical characteristics at inclusion
Measurement of clinical characteristics at inclusion: sex
Measured: 6 months after the inclusion
Clinical characteristics at inclusion
Measurement of clinical characteristics at inclusion: weight in kg and height in cm which will be combined to calculate the BMI (kg/m²)
Measured: 6 months after the inclusion
Clinical characteristics at inclusion
Measurement of clinical characteristics at inclusion: medical history
Measured: 6 months after the inclusion
Clinical characteristics at inclusion
Measurement of clinical characteristics at inclusion: treatments
Measured: 6 months after the inclusion
Description of glycemic control at inclusion
Measurement of basic glycemic control : Hba1c average
Measured: 6 months after the inclusion
Description of variability indicators at inclusion
Measurement of basic glycemic variability parameters : continuous glucose measurement data
Measured: 6 months after the inclusion
Evolution of biological parameters of glycemic variability between the inclusion visit and the follow-up visits
Measurement of the variation in blood glycemic variability (continuous glucose measurement data) parameters between the inclusion visit and the different follow-up visits (3 months and 6 months)
Measured: 6 months after the inclusion
Evolution of biological control parameters variability between the inclusion visit and the follow-up visits
Measurement of the variation in blood control parameters variability (HbA1c) between the inclusion visit and the different follow-up visits (3 months and 6 months)
Measured: 6 months after the inclusion
Evolution of BMI between inclusion and follow-up visits
Change in BMI between the baseline visit and the 3-month and 6-month follow-up visits
Measured: 6 months after the inclusion
Evolution of body weight between inclusion and follow-up visits
Change in body weight between the baseline visit and the 3-month and 6-month follow-up visits
Measured: 6 months after the inclusion
Change in questionnaires scores between baseline and follow-up
Change in mSCOFF (Sick, control, one stone, fat, food) scores between the baseline visit and the 6-month follow-up visit
Measured: 6 months after the inclusion
Change in questionnaires scores between baseline and follow-up
Change in QACD (questionnaires of attitudes and behaviors related to diabetes management) scores between the baseline visit and the 6-month follow-up visit
Measured: 6 months after the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start4 Sep 2025
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete Type 1Studies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07151924
- Sponsor's protocol ID
- RC31/24/0571
- Other IDs
- ID-RCB
- Acronym
- CALI-BF
- Status last verified
- Sep 2025
- First submitted
- 18 Jul 2025
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eating Disturbances in Patients With Type 1 Diabetes Initiating Closed-loop Insulin Therapy: Prevalence and Influence on Glycemic Control
- ClinicalTrials.gov ID
- NCT07151924
- Acronym / sponsor ID
- CALI-BF / RC31/24/0571
- Conditions
- Diabete Type 1
- Keywords
- diabete type 1, eating disorders, eating, insulin, insulin therapy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 4 Sep 2025 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 3 Sep 2025 (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 prevalence of eating disorders is particularly high among people with type 1 diabetes (T1D). These abnormalities, such as "diabulimia," are frequently responsible for poor insulin therapy management and, consequently, chronic glycemic imbalance, exposing them to an increased risk of complications. Their detection and management unfortunately remain insufficient in current practice.
However, to date, no study has addressed the question of the prevalence and impact of eating disorders in this context. Our research hypotheses are therefore as follows:
- The existence of an eating disorder is likely frequently overlooked and, therefore, not taken into account in patients with T1D initiating semi-automated insulin therapy with BF.
- The existence of an eating disorder could impair the performance of the BF device in terms of improving glycemic control in patients with T1D initiating this treatment method.
Patients clinical characteristics, glycemic monitoring parameters ad questionnaires answers will be recorded. The prevalence of eating disorders will be calculated, and the association between the presence of these abnormalities and baseline clinical characteristics and glycemic control parameters will be analyzed.
Detailed description
The prevalence of eating disorders (EDs) and problematic eating behaviors (PEBs) is particularly high among people with type 1 diabetes (T1D), affecting 20 to 50% of women and 5 to 25% of men among young patients. These abnormalities, such as "diabulimia," are frequently responsible for poor insulin therapy management and, consequently, chronic glycemic imbalance, exposing them to an increased risk of complications. Their detection and management unfortunately remain insufficient in current practice.
The treatment of T1D is currently undergoing a veritable technological revolution linked to the arrival of the first semi-automated insulin therapy devices (or closed loop, LF). The use of these devices most often makes it possible to achieve recommended glycemic control targets (HbA1c, continuous glucose monitoring [CGM] data), reduce glycemic variability, and avoid hypoglycemia. Insulin administration is based on the data transmitted: food intake and quantity of carbohydrates consumed. The role of dietitians is therefore crucial in the therapeutic education of patients and the care pathway imposed by the initiation of this new treatment method. It is likely that many patients initiating automated insulin therapy with BF present an eating disorder or CAP that may interfere with the management of the device.
However, to date, no study has addressed the question of the prevalence and impact of eating disorders and CAP in this context. In the absence of available data, national and international recommendation texts dedicated to insulin therapy with BF do not specify appropriate conduct for patients presenting with these eating disorders. Our research hypotheses are therefore as follows:
- The existence of an eating disorder (ED and/or CAP) is likely frequently overlooked and, therefore, not taken into account in patients with T1D initiating semi-automated insulin therapy with BF.
- The existence of an eating disorder (ED and/or CAP) could impair the performance of the BF device in terms of improving glycemic control in patients with T1D initiating this treatment method.
Patients clinical characteristics and glycemic monitoring parameters (HbA1c and CGM data), available as part of routine care, will be recorded in an electronic case report (REDCap software). The mSCOFF and QACD questionnaires will be administered during the dietary interview preceding BF device implantation, and responses will be collected. The prevalence of eating disorders will be calculated, and the association between the presence of these abnormalities and baseline clinical characteristics and glycemic control parameters will be analyzed.
The care pathway established for initiating BF treatment requires a follow-up medical consultation at 3 months, followed by a consultation at 6 months. As part of the study, visits at 3 months (12 ± 2 weeks) and 6 months (24 ± 4 weeks) will be scheduled and will include an interview with a dietitian, to collect glycemic control parameters (at 3 and 6 months), measure body weight (at 3 and 6 months), and repeat the mSCOFF and QACD questionnaires (at 6 months). Data on the evolution of glycemic control and variability parameters, weight and mSCOFF and QACD scores will be analyzed in the overall study population, then according to the existence or not of disturbances in eating behavior at inclusion.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with type 1 diabete | – | Other: Questionnaires answers, Other: Biological assessmentPatients with type 1 diabete with closed-loop therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with type 1 diabetes for whom closed-loop insulin therapy has been recommended
Key inclusion criteria (3 listed)
- Patient diagnosed with type 1 diabetes.
- Patient with a CGM device for more than 3 months with > 80% of data captured in the last month.
- Indication for the implementation of a BF device as part of routine care, in the Diabetology, Metabolic Diseases and Nutrition Department of the Toulouse University Hospital (initiating center).
Key exclusion criteria (6 listed)
- Pregnant or breastfeeding women, or those planning to become pregnant within 6 months of inclusion.
- History of obesity surgery or a preparatory program for obesity surgery planned during the study period.
- Pharmacological treatment likely to significantly influence food intake and body weight, whether ongoing or discontinued within the last 3 months (e.g., GLP-1R agonist): Liraglutide (Victoza®, Saxenda®), Semaglutide (Ozempic®, Wegovy®), Dulaglutide (Trulicity®), Tirzepatde (Mounjaro®), Orlistat (Xenical®)
- Eating disorder requiring specific treatment in the previous 12 months.
- Refusal or inability to consent to participate.
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 |
|---|---|---|
| Questionnaires answersPatients will be asked to complete the MScoff and QACD questionnaires during interviews with the dietitian at baseline, 3 months and 6 months. | Other | Patients with type 1 diabete |
| Biological assessmentCollection of HbA1c level and continuous glucose monitoring data | Other | Patients with type 1 diabete |
Primary outcome
Prevalence of eating disorders
Time frame: 6 months after the inclusion
The primary outcome measure for establishing the prevalence of eating disorders is a composite outcome measure based on determining the existence of eating disorders [ED] by analyzing responses to the mSCOFF questionnaire (score ≥ 2) and/or problematic eating behaviors [PEB] by analyzing responses to the QACD questionnaire (score ≥ 20).
14 secondary outcomes
Prevalence of eating disorders (EDs)
Time frame: 6 months after the inclusion
Clinical characteristics at inclusion
Time frame: 6 months after the inclusion
Clinical characteristics at inclusion
Time frame: 6 months after the inclusion
Clinical characteristics at inclusion
Time frame: 6 months after the inclusion
Clinical characteristics at inclusion
Time frame: 6 months after the inclusion
Clinical characteristics at inclusion
Time frame: 6 months after the inclusion
Description of glycemic control at inclusion
Time frame: 6 months after the inclusion
Description of variability indicators at inclusion
Time frame: 6 months after the inclusion
Evolution of biological parameters of glycemic variability between the inclusion visit and the follow-up visits
Time frame: 6 months after the inclusion
Evolution of biological control parameters variability between the inclusion visit and the follow-up visits
Time frame: 6 months after the inclusion
Evolution of BMI between inclusion and follow-up visits
Time frame: 6 months after the inclusion
Evolution of body weight between inclusion and follow-up visits
Time frame: 6 months after the inclusion
Change in questionnaires scores between baseline and follow-up
Time frame: 6 months after the inclusion
Change in questionnaires scores between baseline and follow-up
Time frame: 6 months after the inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Diabete Type 1
Recruiting
Continuous Monitoring of Plantar Temperature Variations Using Connected Insoles and a Mobile Application for Diabetic Foot.
Diabetic Foot Disease, Diabetic Foot Infection
Recruiting
Differentiating Heart Disease Between Adult-onset Autoimmune and Type 2 Diabetes
Diabete Mellitus, Autoimmune Diabetes
RecruitingPhase 4
Cholesterol Lowering and Residual Risk in Diabetes, Type 1
Type 1 Diabetes
Not yet recruitingPhase 1/2
Study of the Safety and Efficacy of Pancreatic Endocrine Cells in Adult Patients With Type 1 Diabetes
Diabete Mellitus, Diabete Type 1
RecruitingObservational study
Strategy For Assessing The Risk Of Type 1 Diabetes In Pediatric Celiac Patients
Diabete Type 1
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabete Type 1, run by University Hospital, Toulouse 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 6 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: under way, not looking for participants, as of the sponsor's last update on 24 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Prevalence of eating disorders (time frame: 6 months after the 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 24 Sep 2025.