About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial 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
Trial design
Cohort
Retrospective
Treatments tested in this trial
Routine care data collection
Other interventionData 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
Treatment groups
Trial outcomes
Primary outcomes
Difference in Time in Range (0.70-1.80 g/L) between baseline (M0) and Month 6 (M6)
Secondary outcomes
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
Difference in time spent in hypoglycemia (Time Below Range, TBR < 0.70 g/L) between M3 and M0 and between M6 and M0
Difference in time spent in severe hypoglycemia (Time Below Range, TBR < 0.54 g/L) between M3 and M0 and between M6 and M0
Difference in time spent in hyperglycemia (Time Above Range, TAR > 1.80 g/L) between M3 and M0 and between M6 and M0
Sponsors and contacts
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Assistance Publique - Hôpitaux de Paris
Lead sponsor
GIRCI IDF
Collaborator
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