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

Hopital Nord Franche-Comte

Status: Terminated

Conditions: Diabete Mellitus; Insulin Dependent Diabetes

Treatments: Other: Diabetes Therapeutic Education conducted by nurses

Study type: Interventional

Funder types: Other

Identifiers

NCT06167499

2021-05-DIABETE COACH

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7 participants in 2 patient groups

Therapeutic Education Group.

Experimental group

Description:

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

Treatment:

Other: Diabetes Therapeutic Education conducted by nurses

Standard

No Intervention group

Description:

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