Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06148376 | RECRUITING | Type 2 Diabetes Mellitus

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

Hospital Arnau de Vilanova

Information provided by (Responsible Party):

Marta Hernandez Garcia

Brief 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)

Condition or disease

Type 2 Diabetes Mellitus

Multiple Dose Insulin Therapy

Intervention/treatment

Personalized treatment

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 239 participants
Official Title : Application of a Protocol of Personalized Medicine in Patients With Type 2 Diabetes Mellitus and Multiple Doses of Insulin in Routine Clinical Care
Actual Study Start Date : 2023-11-01
Estimated Primary Completion Date : 2025-07-01
Estimated Study Completion Date : 2025-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Application of a Protocol of Personalized Medicine in Patients With Type 2 Diabetes Mellitus and Multiple Doses of Insulin in Routine Clinical Care

Location Details

NCT06148376

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

Spain,

Arnau de Vilanova University Hospital

Lleida, Spain, 25198

RECRUITING

Spain,

Primary Care Centers Lleida, Alt Pirineu and Aran

Lleida, Spain,