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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-69
SponsorAssistance Publique - Hôpitaux de Paris

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Routine care data collection

    Other intervention

    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

Treatment groups

163 Participants
are divided into 1 treatment group
Group A: Patients receiving routine care under a cooperation protocol for prandial insulin adjustment1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline and 6 months

Secondary outcomes

1

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

Time frame
Baseline and 3 months
2

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

Time frame
Baseline, 3 months and 6 months
3

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

Time frame
Baseline, 3 months and 6 months
4

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

Time frame
Baseline, 3 months and 6 months

Other outcomes

Sponsors and contacts

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