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NCT06148376Completed

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

Source: ClinicalTrials.gov · Last updated 11 Mar 2026

Brief summary (registry, in English)

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)

Status (registry)
Completed
Study type
Observational
Enrollment
239 (actual)
First submitted
18 Nov 2023
Start date
1 Dec 2023
Primary completion date
30 Sept 2025
Lead sponsor
Hospital Arnau de Vilanova
NCT number
NCT06148376

What you commit to

  • Study type: Observational
  • Participants enrolled: 239
  • From 1 Dec 2023 to the primary completion date, 30 Sept 2025
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Drug or alcohol abuse

Other illness

  • Glucocorticoid use for an acute condition
  • Any condition that prevents the patient or their caregiver from following up for 6 months
  • Severe mental illness

Other

  • Gestation or planning gestation in the following 12 months
  • Transient insulinisationt (less than 6 months)

Who the study is looking for

  • Type 2 diabetes treated with multiple dose insulin therapy

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital Universitari Arnau de Vilanova
Coordinator of this site? Confirm its status
LleidaSpainUnknown status
Centres Atenció Primària Lleida, Alt Pirineu i Aran
Coordinator of this site? Confirm its status
LleidaSpainUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.