Therapeutic Education Consultations With Diabetic Patients Treated With Intensified Insulin Therapy

Not Applicable

Terminated

• Conditions: Diabete Mellitus; Insulin Dependent Diabetes

• Registration Number: NCT06167499
• Lead Sponsor: Hopital Nord Franche-Comte

Brief Summary

Diabetes is a chronic condition that affects around 8% of the French population, and is associated with severe complications. Maintaining a constant blood glucose level of between 0.7 and 1.80 g/l is the day-to-day objective of diabetic patients.Insulin can be administered by injection via syringes or pens, or by insulin pumps and patients can perform self-monitoring of blood glucose.

All these actions can be the subject of therapeutic education, which involves a range of tools, including dedicated individual consultations carried out by state-qualified nurses.

The aim of the study is to evaluate the benefit of therapeutic education consultations conducted by nurses in addition to medical consultations, on the follow-up of diabetic patients, insulin pump carriers or treated with multiple injections, in terms of glycemic control, quality of life and medical complications. The objective of the study is to evaluate whether the therapeutic education consultations conducted by nurses can improve the care of the diabetic patient.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-24
• Study First Submitted QC: 2023-12-04
• Study First Posted: 2023-12-12
• Study Start: 2024-02-09
• Primary Completion: 2024-10-11
• Study Completion: 2025-03-01
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-07
• Last Update Posted: 2025-08-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

• Woman or man aged 18 to 75
• Diabetic patient type 1 or 2 insulin-dependent
• Patient treated with multi-injections or insulin pump
• Patient equipped with FreeStyle Libre flash glucose monitoring system
• Glycemic imbalance with HBA1c > 8
• Patient living at home

Exclusion Criteria

• Recent discovery (< 6 months) of diabetes
• Major intellectual disability
• Social isolation
• IMC > 35
• Pregnant women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rate of glycated hemoglobin HBA1c	12 months	Difference in HBA1c between baseline and 12 months (M12)

Secondary Outcome Measures

Name	Time	Method
Evaluation of patients' quality of life over 18 months	18 months	Questionnaire assessing quality of life (Audit of Diabetes Dependent Quality of Life - 19 items: ADDQoL 19)
Evaluation of long-term complications over 18 months	18 months	Assessment of the development and evolution of diabetes-related complications: neuropathy, nephropathy, retinopathy, arteriopathy, erectile dysfunction, heart disease, hypertension, foot ulcers, amputations and cerebrovascular damage.; Number of additional hospitalizations and urgent consultations for acute or chronic complications.
Evaluation of glycemic control over 18 months	18 months	Evaluation via Freestyle free blood glucose sensor with free view software every 6 months, over the last month and the last 3 months prior to medical consultation: * % of time spent in target range (0.7 g/l ≤ blood glucose ≤ 1.8g/l); * % of time spent in hypoglycemia (blood glucose \<0.7 g/l,; * % of time spent in hyperglycemia (blood glucose \> 1.8g/l) Recording of ketoacidosis episodes during patient attendance Recording of episodes of severe hypoglycemia requiring third-party assistance with the patient HBA1c monitoring every 3 months
Evaluation of patients' satisfaction with diabetes treatment	18 months	Questionnaire assessing satisfaction with diabetes treatment (Diabetes Treatment Satisfaction Questionnaires: DTSQs)

Trial Locations

Locations (1)

Hôpital Nord Franche-Comté; 🇫🇷 Trévenans, France