NCT06148376

Application of a Protocol of Personalized Medicine in Patients With Type 2 Diabetes Mellitus and Multiple Doses of Insulin in Routine Clinical Care

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 239 (actual)
• Sponsor: Hospital Arnau de Vilanova · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to test a protocol of personalized medicine in routine clinical practice in people with type 2 diabetes (T2DM) treated with multiple dose insulin injections (MDI). The main question\[s\] it aims to answer are: • Are c-peptide titers and B-cell autoimmunity useful to help the decision of suspending prandial insulin in patients with T2DM treated with MDI? Participants will: * Wear a continuous glucose monitor for 10-14 days * Will be asked for a C-peptide and GAD antibody test (GADA) * Will stop prandial insulin and switch to other diabetes treatments if needed if c-peptide is \> 0.7 mmol/L and/or C-peptide is \> 0.3 mmol/L and GADA are negative * Will be followed-up by their GP in routine clinical practice * Will be assessed after 6 months (CGM, HbA1c, quality of life (QoL)

Detailed description

An algorithm will be applied in which, depending on the presence/absence of pancreatic autoimmunity and the estimation of pancreatic reserve, the same treatment will be maintained and CGM (continuous glucose monitoring) will be initiated or the prandial insulin and the treatment will be adjusted following the main clinical guidelines.

Conditions

• Type 2 Diabetes Mellitus
• Multiple Dose Insulin Therapy

Interventions

Type	Name	Description
OTHER	Personalized treatment	Discontinue prandial insulin treatment

Timeline

• Start date: 2023-12-01
• Primary completion: 2025-09-30
• Completion: 2025-09-30
• First posted: 2023-11-28
• Last updated: 2026-03-11

Locations

2 sites across 1 country: Spain