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

NCT06148376 | Completed

• 1 other identifier: 2965LO
• Study Type: observational
• Target: 239
• Locations: 1 country
• Sites: 2

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)

Conditions

Type 2 Diabetes Mellitus; Multiple Dose Insulin Therapy

Keywords

Type 2 Diabetes Meliitus; Multiple dose insulin therapy; personalized medicine

Outcome Measures

Primary Outcomes (1)

• Percentage of patients whose prandial insulin is withdrawn

  Percentage of patients whose prandial insulin is withdrawn

  At 6 months from the inclusion

Secondary Outcomes (5)

• Glucose control

  6 months

• Number of severe hypoglycaemia events

  6 months

• Diabetes quality of life

  6 months

• Adherence to trearment

  6 months

• Diabetes treatment satisfaction

  6 months

Study Arms (1)

MDI T2DM

Patients wit type 2 diabetes (T2DM) treated with multiple dose insulin therapy (MDI)

Other: Personalized treatment

Interventions

Personalized treatment OTHER

Discontinue prandial insulin treatment

MDI T2DM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Type 2 diabetes treated with multiple dose insulin therapy

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Arnau de Vilanova: lead
• Institut Catala de Salut: collaborator

Study Sites (2)

Hospital Universitari Arnau de Vilanova

Lleida, 25198, Spain

Location

Centres Atenció Primària Lleida, Alt Pirineu i Aran

Lleida, Spain

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Marta Hernández, MD PhD

  Hospital Arnau de Vilanova

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: November 18, 2023
• First Posted: November 28, 2023
• Study Start: December 1, 2023
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)