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

Hospital Arnau de Vilanova

Status

Enrolling

Conditions

Type 2 Diabetes Mellitus

Multiple Dose Insulin Therapy

Treatments

Other: Personalized treatment

Study type

Observational

Funder types

Other

Identifiers

NCT06148376

2965LO

Details and patient eligibility

About

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)

Full 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.

Enrollment

239 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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