Therapeutic Education Consultations With Diabetic Patients Treated With Intensified Insulin Therapy

Diabete Mellitus Clinical Trial

— DIABETE COACH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06167499
• Other study ID #: 2021-05-DIABETE COACH
• Status: Recruiting
• Phase: N/A
• Start date: February 9, 2024
• Est. completion date: July 25, 2028

Study information

• Verified date: November 2023
• Source: Hopital Nord Franche-Comte
• Contact: Elodie Bouvier
• Phone: +33 3 84 98 35 70
• Email: elodie.bouvier[@]hnfc.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 192
• Est. completion date: July 25, 2028
• Est. primary completion date: February 9, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabete Mellitus
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Insulin Dependent Diabetes

Intervention

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.

Locations

Country	Name	City	State
France	Hôpital Nord Franche-Comté	Trévenans

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Nord Franche-Comte

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of glycated hemoglobin HBA1c	Difference in HBA1c between baseline and 12 months (M12)	12 months
Secondary	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
Secondary	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
Secondary	Evaluation of patients' satisfaction with diabetes treatment	Questionnaire assessing satisfaction with diabetes treatment (Diabetes Treatment Satisfaction Questionnaires: DTSQs)	18 months
Secondary	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