Personalized medicine approach for patients with type 2 diabetes on insulin
Application of a Protocol of Personalized Medicine in Patients With Type 2 Diabetes Mellitus and Multiple Doses of Insulin in Routine Clinical Care
This study is testing a personalized approach to insulin treatment for people with type 2 diabetes to see if adjusting their therapy based on specific tests can improve their blood sugar control and overall well-being.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 239 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Arnau de Vilanova Academic / other |
| Locations | 2 sites (Lleida and 1 other locations) |
| Trial ID | NCT06148376 on ClinicalTrials.gov |
What this trial studies
This observational study aims to implement a personalized medicine protocol in routine clinical care for individuals with type 2 diabetes mellitus (T2DM) who are receiving multiple doses of insulin. Participants will wear a continuous glucose monitor for 10-14 days and undergo tests for C-peptide and GAD antibodies to assess their pancreatic function and autoimmunity. Based on these results, adjustments to their insulin therapy may be made, including the potential suspension of prandial insulin if certain criteria are met. Follow-up assessments will be conducted after six months to evaluate glucose control and quality of life.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with type 2 diabetes who are currently treated with multiple dose insulin therapy.
Not a fit: Patients who are pregnant or planning to become pregnant within the next 12 months, or those with conditions that prevent follow-up, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could optimize insulin therapy and improve overall management of type 2 diabetes in patients.
How similar studies have performed: Other studies have shown promise in personalized medicine approaches for diabetes management, suggesting potential success for this protocol.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Type 2 diabetes treated with multiple dose insulin therapy Exclusion Criteria: * Gestation or planning gestation in the following 12 months * Glucocorticoid use for an acute condition * Transient insulinisationt (less than 6 months) * Any condition that prevents the patient or their caregiver from following up for 6 months * Severe mental illness * Drug or alcohol abuse
Where this trial is running
Lleida and 1 other locations
- Hospital Universitari Arnau de Vilanova — Lleida, Spain (Recruiting)
- Centres Atenció Primària Lleida, Alt Pirineu i Aran — Lleida, Spain (Recruiting)
Study contacts
- Principal investigator: Marta Hernández, MD PhD — Hospital Arnau de Vilanova
- Study coordinator: Marta Hernández, MD PhD
- Email: martahernandezg@gmail.com
- Phone: 973705183
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.