Clinical trial NCT06148376: Application of a Protocol of Personalized Medicine in Patients With Type 2 Diabetes Mellitus and Multiple Doses of Insulin in Routine Clinical Care
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 2 Diabetes Mellitus
Multiple Dose Insulin Therapy
Keywords: Type 2 Diabetes Meliitus
Multiple dose insulin therapy
personalized medicine
Lead sponsor: Hospital Arnau de Vilanova
Sponsor class: OTHER
Collaborators: name: Institut Catala de Salut
First posted: 2023-11-28
Enrollment: 239
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the patients in our territory treated with multiple dose insulin therapy without exclusion criteria are elegible to participate.

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)

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.

Eligibility 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

Primary outcomes:
measure: Percentage of patients whose prandial insulin is withdrawn
timeFrame: At 6 months from the inclusion
Secondary outcomes:
measure: Glucose control
timeFrame: 6 months
measure: Number of severe hypoglycaemia events
timeFrame: 6 months
measure: Diabetes quality of life
timeFrame: 6 months
measure: Adherence to trearment
timeFrame: 6 months
measure: Diabetes treatment satisfaction
timeFrame: 6 months
Other outcomes:
Locations:
city: Lleida
country: Spain
facility: Hospital Universitari Arnau de Vilanova
city: Lleida
country: Spain
facility: Centres Atenció Primària Lleida, Alt Pirineu i Aran
Study officials:
affiliation: Hospital Arnau de Vilanova
name: Marta Hernández, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: