Therapeutic education for diabetic patients using insulin therapy
Impact of Therapeutic Education Consultations Conducted by Specialized Nurses on Glycemic Control and Quality of Life in Diabetic Patients Treated With Intensified Insulin Therapy: a Randomized Study
This study tests if educational support from nurses can help people with diabetes who use insulin feel better and manage their blood sugar more effectively.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 192 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Hopital Nord Franche-Comte Academic / other |
| Locations | 1 site (Trévenans) |
| Trial ID | NCT06167499 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of therapeutic education consultations conducted by qualified nurses for diabetic patients who are treated with intensified insulin therapy. The focus is on patients using insulin pumps or multiple injections, aiming to improve glycemic control, quality of life, and reduce medical complications. The consultations will complement regular medical check-ups and utilize tools like the FreeStyle Libre glucose monitoring system to track patient progress. The study seeks to determine if these educational interventions can lead to better health outcomes for participants.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with type 1 or type 2 insulin-dependent diabetes, experiencing glycemic imbalance and using an insulin pump or multiple injections.
Not a fit: Patients who have recently been diagnosed with diabetes, have major intellectual disabilities, or are socially isolated may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve glycemic control and overall quality of life for insulin-dependent diabetic patients.
How similar studies have performed: Other studies have shown positive outcomes with therapeutic education for diabetes management, suggesting this approach is promising.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Trévenans
- Hôpital Nord Franche-Comté — Trévenans, France (Recruiting)
Study contacts
- Principal investigator: Elena BOUCHEZ — Hopital Nord Franche-Comte
- Study coordinator: Elodie Bouvier
- Email: elodie.bouvier@hnfc.fr
- Phone: +33 3 84 98 35 70
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.