Therapeutic Education Consultations With Diabetic Patients Treated With Intensified Insulin Therapy (DIABETE COACH)

Impact of Therapeutic Education Consultations Conducted by Specialized Nurses on Glycemic Control and Quality of Life in Diabetic Patients Treated With Intensified Insulin Therapy: a Randomized Study

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.

Study Overview

• Status: Terminated
• Conditions: Diabete Mellitus; Insulin Dependent Diabetes
• Intervention / Treatment: Other: Diabetes Therapeutic Education conducted by nurses

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Trévenans, France
    • Hôpital Nord Franche-Comté

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Therapeutic Education Group.; Medical follow-up every 6 months for 18 months (inclusion, M6, M12, M18) associated with therapeutic education consultations conducted by nurses in the month following inclusion (between D0 and M1), M3, M9 and M15	Other: Diabetes Therapeutic Education conducted by nurses; Individual consultations with the therapeutic education IDE, who will help the patient to achieve the therapeutic objectives set before the medical consultation. Once the objectives have been set, the IDE will set up individual workshops and subsequently assess the patient's learning and its impact on his or her care. These workshops can include equipment demonstrations and practical exercises, explanations of treatment adaptation protocols, and dietary or sexual advice.
No Intervention: Standard; Medical follow-up every 6 months for 18 months (Inclusion, M6, M12, M18) :usual practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of glycated hemoglobin HBA1c	Difference in HBA1c between baseline and 12 months (M12)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of glycemic control over 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	18 months
Evaluation of patients' quality of life over 18 months	Questionnaire assessing quality of life (Audit of Diabetes Dependent Quality of Life - 19 items: ADDQoL 19)	18 months
Evaluation of patients' satisfaction with diabetes treatment	Questionnaire assessing satisfaction with diabetes treatment (Diabetes Treatment Satisfaction Questionnaires: DTSQs)	18 months
Evaluation of long-term complications over 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.	18 months

Collaborators and Investigators

• Sponsor: Hopital Nord Franche-Comte
• Investigators: Principal Investigator: Elena BOUCHEZ, Hôpital Nord Franche-Comté

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2024
• Primary Completion (Actual): October 11, 2024
• Study Completion (Actual): March 1, 2025

Study Registration Dates

• First Submitted: November 24, 2023
• First Submitted That Met QC Criteria: December 4, 2023
• First Posted (Actual): December 12, 2023

Study Record Updates

• Last Update Posted (Actual): August 8, 2025
• Last Update Submitted That Met QC Criteria: August 7, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 2021-05-DIABETE COACH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No