An interventional study of Diabetes Therapeutic Education conducted by nurses in Diabete Mellitus and Insulin Dependent Diabetes, sponsored by Hopital Nord Franche-Comte. Terminated at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-08-08.
Sponsored by Hopital Nord Franche-Comte · Not applicable, Interventional, and Supportive care
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.
8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.
This study's enrollment of 7 is below the median of 80 across 6,023 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Hopital Nord Franche-Comte is the lead sponsor of 16 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Other: Diabetes Therapeutic Education conducted by nurses
Medical follow-up every 6 months for 18 months (Inclusion, M6, M12, M18) :usual practice
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.
Rate of glycated hemoglobin HBA1c
Difference in HBA1c between baseline and 12 months (M12)
Time frame: 12 months
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: * % 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
Time frame: 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)
Time frame: 18 months
Evaluation of patients' satisfaction with diabetes treatment
Questionnaire assessing satisfaction with diabetes treatment (Diabetes Treatment Satisfaction Questionnaires: DTSQs)
Time frame: 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.
Time frame: 18 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Feb 2024 to primary completion in Oct 2024, 8 months.
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This study is terminated, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Hopital Nord Franche-Comte