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Futility
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Standard | No Intervention | Medical follow-up every 6 months for 18 months (Inclusion, M6, M12, M18) :usual practice |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of glycated hemoglobin HBA1c | Difference in HBA1c between baseline and 12 months (M12) | 12 months |
| 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:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elena BOUCHEZ | Hopital Nord Franche-Comte | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Nord Franche-Comté | Trévenans | France |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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|
| 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 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |