Therapeutic Education Consultations With Diabetic Patients Treated With Intensified Insulin Therapy

NCT06167499 | Terminated

• 1 other identifier: 2021-05-DIABETE COACH
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabete Mellitus; Insulin Dependent Diabetes

Outcome Measures

Primary Outcomes (1)

• Rate of glycated hemoglobin HBA1c

  Difference in HBA1c between baseline and 12 months (M12)

  12 months

Secondary Outcomes (4)

• Evaluation of glycemic control over 18 months

  18 months

• Evaluation of patients' quality of life over 18 months

  18 months

• Evaluation of patients' satisfaction with diabetes treatment

  18 months

• Evaluation of long-term complications over 18 months

  18 months

Study Arms (2)

Therapeutic Education Group.

EXPERIMENTAL

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

Standard

NO INTERVENTION

Medical follow-up every 6 months for 18 months (Inclusion, M6, M12, M18) :usual practice

Interventions

Diabetes Therapeutic Education conducted by nurses OTHER

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.

Therapeutic Education Group.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hopital Nord Franche-Comte: lead

Study Sites (1)

Hôpital Nord Franche-Comté

Trévenans, France

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Elena BOUCHEZ

  Hopital Nord Franche-Comte

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2023
• First Posted: December 12, 2023
• Study Start: February 9, 2024
• Primary Completion: October 11, 2024
• Study Completion: March 1, 2025
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)