Therapeutic Education Consultations With Diabetic Patients Treated With Intensified Insulin Therapy
- Conditions
- Diabete MellitusInsulin Dependent Diabetes
- Interventions
- Other: Diabetes Therapeutic Education conducted by nurses
- Registration Number
- NCT06167499
- Lead Sponsor
- Hopital Nord Franche-Comte
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 192
- 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
- Recent discovery (< 6 months) of diabetes
- Major intellectual disability
- Social isolation
- IMC > 35
- Pregnant women
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Therapeutic Education Group. Diabetes Therapeutic Education conducted by nurses 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
- Primary Outcome Measures
Name Time Method Rate of glycated hemoglobin HBA1c 12 months Difference in HBA1c between baseline and 12 months (M12)
- Secondary Outcome Measures
Name Time Method 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)
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 monthsEvaluation of patients' satisfaction with diabetes treatment 18 months Questionnaire assessing satisfaction with diabetes treatment (Diabetes Treatment Satisfaction Questionnaires: DTSQs)
Trial Locations
- Locations (1)
Hôpital Nord Franche-Comté
🇫🇷Trévenans, France