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

March 8, 2026 updated by: Marta Hernandez Garcia, Hospital Arnau de Vilanova

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)

Study Overview

Status

Completed

Conditions

Intervention / 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

Enrollment (Actual)

239

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Lleida, Spain, 25198
        • Hospital Universitari Arnau de Vilanova
      • Lleida, Spain
        • Centres Atenció Primària Lleida, Alt Pirineu i Aran

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MDI T2DM
Patients wit type 2 diabetes (T2DM) treated with multiple dose insulin therapy (MDI)
Other: Personalized treatment
Discontinue prandial insulin treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients whose prandial insulin is withdrawn
Time Frame: At 6 months from the inclusion
Percentage of patients whose prandial insulin is withdrawn
At 6 months from the inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucose control
Time Frame: 6 months
HbA1c, continuous glucose monitoring data
6 months
Number of severe hypoglycaemia events
Time Frame: 6 months
Severe hypoglycemia defined in Seaquist ER, Anderson J, Childs B, et al. Hypoglycemia and diabetes: a report of a workgroup of the American Diabetes Association and the Endocrine Society. Diabetes Care. 2013;36(5):1384-1395.
6 months
Diabetes quality of life
Time Frame: 6 months
ESDQoL
6 months
Adherence to trearment
Time Frame: 6 months
ARMS-E questionnaire
6 months
Diabetes treatment satisfaction
Time Frame: 6 months
DTSQs, DTSQc questionnaire
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Arnau de Vilanova

Collaborators

Institut Catala de Salut

Investigators

  • Principal Investigator: Marta Hernández, MD PhD, Hospital Arnau de Vilanova

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Actual)

September 30, 2025

Study Completion (Actual)

September 30, 2025

Study Registration Dates

First Submitted

November 18, 2023

First Submitted That Met QC Criteria

November 18, 2023

First Posted (Actual)

November 28, 2023

Study Record Updates

Last Update Posted (Actual)

March 11, 2026

Last Update Submitted That Met QC Criteria

March 8, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2965LO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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