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

NCT06148376 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 239

Last updated 2026-03-11

No results posted yet for this study

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)

Conditions

Interventions

OTHER

Personalized treatment

Discontinue prandial insulin treatment

Sponsors & Collaborators

  • Institut Catala de Salut

    collaborator OTHER_GOV

  • Hospital Arnau de Vilanova

    lead OTHER

Principal Investigators

  • Marta Hernández, MD PhD · Hospital Arnau de Vilanova

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2025-09-30
Completion
2025-09-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06148376 on ClinicalTrials.gov