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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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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

Other trials in France

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
  1. 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.
  2. 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:

  1. 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.
  2. 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 groups in NCT07151924
Study groupRoleWhat they receive
Patients with type 1 diabetePatients 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.

  1. 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)
  1. Prevalence of eating disorders (EDs)

    Prevalence of EDs (mSCOFF score ≥ 2 and QACD ≥ 20)

    Measured: 6 months after the inclusion

  2. Clinical characteristics at inclusion

    Measurement of clinical characteristics at inclusion: age

    Measured: 6 months after the inclusion

  3. Clinical characteristics at inclusion

    Measurement of clinical characteristics at inclusion: sex

    Measured: 6 months after the inclusion

  4. 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

  5. Clinical characteristics at inclusion

    Measurement of clinical characteristics at inclusion: medical history

    Measured: 6 months after the inclusion

  6. Clinical characteristics at inclusion

    Measurement of clinical characteristics at inclusion: treatments

    Measured: 6 months after the inclusion

  7. Description of glycemic control at inclusion

    Measurement of basic glycemic control : Hba1c average

    Measured: 6 months after the inclusion

  8. Description of variability indicators at inclusion

    Measurement of basic glycemic variability parameters : continuous glucose measurement data

    Measured: 6 months after the inclusion

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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.

  1. First posted3 Sep 2025
  2. Study start4 Sep 2025
  3. Primary completion28 Feb 2027 (estimated)
  4. Study completion28 Feb 2027 (estimated)

Resources

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
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

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.

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