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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Observational
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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Type 2 diabetes treated with multiple dose insulin therapy

Locations
Other Locations
Spain
Centres Atenció Primària Lleida, Alt Pirineu i Aran
RECRUITING
Lleida
Hospital Universitari Arnau de Vilanova
RECRUITING
Lleida
Contact Information
Primary
Marta Hernández, MD PhD
martahernandezg@gmail.com
973705183
Time Frame
Start Date: 2023-11-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 239
Treatments
MDI T2DM
Patients wit type 2 diabetes (T2DM) treated with multiple dose insulin therapy (MDI)
Related Therapeutic Areas
Sponsors
Collaborators: Institut Catala de Salut
Leads: Hospital Arnau de Vilanova

This content was sourced from clinicaltrials.gov