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Clinical Trials in France / NCT07846852
Starting soon Observational

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

NCT07846852 · tracked via the Priya Life Science France tracker
Sponsor
Assistance Publique - Hôpitaux de Paris
Phase
Observational
Started
2026-10
Last updated
2026-09-29

Condition(s) studied

Diabetes Mellitus, Type 1

Investigational drug(s) / intervention(s)

Routine care data collection

Routine care data collection: Data collection from patients receiving standard care under a cooperation protocol for prandial insulin dose adjustment, with data collected from patients' medical records and glucose monitoring platforms without modifying patient management

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
69 Years
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * Unstable severe proliferative diabetic retinopathy. * Any type of diabetes other than type 1 diabetes or insulin-deficient diabetes. * Pregnant women with type 1 diabetes. * Current treatment with temporary therapies that may affect insulin requirements (e.g., chemotherapy or systemic corticosteroid therapy). * Individuals under legal guardianship, curatorship, or any other legal protection measure. * Objection to the use of personal data for research purposes

Primary outcome measure(s)

  • Difference in Time in Range (0.70-1.80 g/L) between baseline (M0) and Month 6 (M6) — Baseline and 6 months

Trial sites (2)

FacilityCityRegionStatus
Service de diabétologie, Hôpital Lariboisière - AP-HP Paris France
Service de nutrition - diabétologie, Hôpital Européen Georges Pompidou - AP-HP Paris France

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Other trials for the same condition

A Study of Baricitinib (LY3009104) to Preserve Beta Cell Function in Children and Adults Newly Diagnosed With Type 1 Diabetes (BARICADE-PRESERVE) Recruiting
Study of the Impact of PROximity Support for Patients With Type 1 DIABetes Treated With an Insulin Pump or Closed Loop. Recruiting
Recent-Onset Type 1 Diabetes Extension Study Evaluating the Long-Term Safety of Teplizumab (PROTECT Extension) Active, not recruiting
The Real-World Control-IQ Glycemic Control and Quality of Life Study in Type 1 Diabetes in France Recruiting
A Safety, Tolerability, and Efficacy Study of VX-880 and VX-017 in Participants With Type 1 Diabetes Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07846852 on ClinicalTrials.gov ↗ ← All trials in France