Diabete Mellitus, Insulin Dependent Diabetes
Conditions
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.
Interventions
OTHERDiabetes 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.
Sponsors
Hopital Nord Franche-Comte
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of glycated hemoglobin HBA1c | 12 months | Difference in HBA1c between baseline and 12 months (M12) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of patients' satisfaction with diabetes treatment | 18 months | Questionnaire assessing satisfaction with diabetes treatment (Diabetes Treatment Satisfaction Questionnaires: DTSQs) |
| Evaluation of long-term complications over 18 months | 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. |
| Evaluation of glycemic control over 18 months | 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 |
| Evaluation of patients' quality of life over 18 months | 18 months | Questionnaire assessing quality of life (Audit of Diabetes Dependent Quality of Life - 19 items: ADDQoL 19) |
Countries
France
Outcome results
None listed