Therapeutic Education Consultations With Diabetic Patients Treated With Intensified Insulin Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-09

Study Completion Date

2025-03-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabete Mellitus Insulin Dependent Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Diabetes Therapeutic Education conducted by nurses

Intervention Type 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.

Standard

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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