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NCT07846852Not yet recruiting

Impact of Dietary Intervention Within an Interprofessional Cooperative Protocol for Prandial Insulin Dose Adjustment in People Living With Type 1 Diabetes

Source: ClinicalTrials.gov · Last updated 29 Sept 2026

Brief summary (registry, in English)

This retrospective multicenter cohort study aims to evaluate the effectiveness of an interprofessional cooperative protocol allowing dietitians to adjust prandial insulin-to-carbohydrate ratios in adults living with type 1 diabetes receiving functional insulin therapy. Glycemic outcomes will be assessed using continuous glucose monitoring data collected during routine clinical care. The primary endpoint is the change in Time in Range (TIR) between baseline and 6 months.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
163 (estimated)
First submitted
22 Sept 2026
Start date
Oct 2026
Primary completion date
Apr 2028
Lead sponsor
Assistance Publique - Hôpitaux de Paris
NCT number
NCT07846852

What you commit to

  • Study type: Observational
  • Planned participants: 163
  • From Oct 2026 to the primary completion date, Apr 2028
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Current treatment with temporary therapies that may affect insulin requirements (e.g., chemotherapy or systemic corticosteroid therapy).

Other illness

  • Any type of diabetes other than type 1 diabetes or insulin-deficient diabetes.
  • Pregnant women with type 1 diabetes.

Other

  • Unstable severe proliferative diabetic retinopathy.
  • Individuals under legal guardianship, curatorship, or any other legal protection measure.
  • Objection to the use of personal data for research purposes

Who the study is looking for

  • Male or female, aged 18 to 69 years.
  • Receiving routine clinical care under an interprofessional cooperation protocol for prandial insulin dose adjustment (protocol implemented since January 1, 2023).
  • Living with type 1 diabetes mellitus or insulin-deficient diabetes, confirmed by the presence of anti-GAD, anti-IA2, anti-ZnT8, or insulin autoantibodies, and requiring optimization of insulin therapy.
  • Diabetes duration greater than 6 months.
  • Treated with multiple daily insulin injections or an insulin pump (open-loop or hybrid closed-loop system).
  • Completion of a structured therapeutic education program in functional insulin therapy (individual consultations and/or educational workshops).
  • Able to understand study information and procedures.

Age in the registry: 18 years to 69 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Service de nutrition - diabétologie, Hôpital Européen Georges Pompidou - AP-HP
Coordinator of this site? Confirm its status
ParisFranceUnknown status
Service de diabétologie, Hôpital Lariboisière - AP-HP
Coordinator of this site? Confirm its status
ParisFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.