Dietitian-Led Mealtime Insulin Adjustment in Adults With Type 1 Diabetes
Looks back at dietitians adjusting mealtime insulin doses in adults with type 1 diabetes.
Key facts
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Where
- Paris, FranceSee the 2 sites
- Trial code
- Registry title
- Impact of Dietary Intervention Within an Interprofessional Cooperative Protocol for Prandial Insulin Dose Adjustment in People Living With Type 1 Diabetes
- Status
- Not yet recruiting
- People taking part
- 163 people, planned
- Started
- Oct 2026
- Expected to end
- Apr 2028
- Type of study
- Observational
- Treatments tested
- Routine care data collection
- Record updated
- 29 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 69 with type 1 diabetes who are on flexible mealtime insulin dosing and get care under a dietitian-led insulin adjustment protocol.
- Age
- 18 to 69 years
- Sex
- Women and men can join.
- Disease stage
- Type 1 diabetes or insulin-deficient diabetes, confirmed by autoantibodies (anti-GAD, anti-IA2, anti-ZnT8 or insulin), with diabetes for more than 6 months.
- Earlier treatment
- Must be on multiple daily insulin injections or an insulin pump, and must have completed a structured education program in functional insulin therapy. Must be getting care under the interprofessional protocol in place since January 1, 2023.
- Biomarker or test result
- Presence of anti-GAD, anti-IA2, anti-ZnT8 or insulin autoantibodies.
Main reasons for not taking part
- Unstable severe proliferative diabetic retinopathy
- Any type of diabetes other than type 1 or insulin-deficient diabetes
- Pregnant women with type 1 diabetes
- Current temporary treatment that may change insulin needs, such as chemotherapy or systemic corticosteroids
- Under legal guardianship or other legal protection measure
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- 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
Who cannot take part
- Current treatment with temporary therapies that may affect insulin requirements (e.g., chemotherapy or systemic corticosteroid therapy)
- Any type of diabetes other than type 1 diabetes or insulin-deficient diabetes
- Pregnant women with type 1 diabetes
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 69 years old?
Where in France
- Service de diabétologie, Hôpital Lariboisière - AP-HPParis, FranceContact: Hélène LouvetNo longer taking part
- Service de nutrition - diabétologie, Hôpital Européen Georges Pompidou - AP-HPParis, FranceContact: Virginie LafailleNo longer taking part
About the trial
What the trial wants to find out
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.
The group in the trial
- Patients receiving routine care under a cooperation protocol for prandial insulin adjustment
Treatment: Routine care data collection
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Impact of Dietary Intervention Within an Interprofessional Cooperative Protocol for Prandial Insulin Dose Adjustment in People Living With Type 1 Diabetes
- Plain-language title
- Dietitian-Led Mealtime Insulin Adjustment in Adults With Type 1 DiabetesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07846852, who can take part
- Record updated
- 29 September 2026