NCT07846852

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
163

participants targeted

Target at P50-P75 for all trials

Timeline
18mo left

Started Oct 2026

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Oct 2026Apr 2028

First Submitted

Initial submission to the registry

September 22, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 29, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

September 29, 2026

Status Verified

September 1, 2026

Enrollment Period

1.5 years

First QC Date

September 22, 2026

Last Update Submit

September 22, 2026

Conditions

Diabetes Mellitus, Type 1

Keywords

Interprofessional cooperative protocolPrandial insulinType 1 diabetesDietitian

Outcome Measures

Primary Outcomes (1)

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

    Baseline and 6 months

Secondary Outcomes (7)

  • Difference in time spent in the glycemic target range (Time in Range, TIR between 0.70 g/L and 1.80 g/L) between M3 and M0

    Baseline and 3 months

  • Difference in time spent in hypoglycemia (Time Below Range, TBR < 0.70 g/L) between M3 and M0 and between M6 and M0

    Baseline, 3 months and 6 months

  • Difference in time spent in severe hypoglycemia (Time Below Range, TBR < 0.54 g/L) between M3 and M0 and between M6 and M0

    Baseline, 3 months and 6 months

  • Difference in time spent in hyperglycemia (Time Above Range, TAR > 1.80 g/L) between M3 and M0 and between M6 and M0

    Baseline, 3 months and 6 months

  • Difference in time spent in severe hyperglycemia (Time Above Range, TAR > 2.50 g/L) between M3 and M0 and between M6 and M0

    Baseline, 3 months and 6 months

  • +2 more secondary outcomes

Study Arms (1)

Patients receiving routine care under a cooperation protocol for prandial insulin adjustment

Other: Routine care data collection

Interventions

Routine care data collectionOTHER

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

Patients receiving routine care under a cooperation protocol for prandial insulin adjustment

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults aged 18-69 years with type 1 diabetes or insulin-deficient diabetes receiving routine care under an interprofessional cooperation protocol for prandial insulin dose adjustment. Eligible participants must have had diabetes for more than 6 months, be treated with multiple daily insulin injections or an insulin pump, and have completed structured education in functional insulin therapy. Patients with unstable proliferative retinopathy, pregnancy, other types of diabetes, temporary treatments affecting insulin requirements, legal protection measures, or who object to the use of their data are excluded

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Service de diabétologie, Hôpital Lariboisière - AP-HP

Paris, France

Location

Service de nutrition - diabétologie, Hôpital Européen Georges Pompidou - AP-HP

Paris, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Virginie Lafaille

    Service de nutrition - diabétologie, Hôpital Européen Georges Pompidou - AP-HP

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Youcef Sekour

CONTACT

+33156095823youcef.sekour@aphp.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2026

First Posted

September 29, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2028

Last Updated

September 29, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share

Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Two years after the last publication
Access Criteria
Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. The founder could be involved in the decision. Teams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization. Processing of shared data must comply with European General Data Protection Regulation (GDPR).

Locations

FR(2)