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OpenTrials
Completed

NCT Number: NCT06148376

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

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)

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Multiple Dose Insulin Therapy Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centres Atenció Primària Lleida, Alt Pirineu i Aran, Lleida, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Personalized treatment

Other

Discontinue prandial insulin treatment

Primary outcomes

  1. Percentage of patients whose prandial insulin is withdrawn

    Time frame: At 6 months from the inclusion

    Percentage of patients whose prandial insulin is withdrawn

Secondary outcomes

  1. Glucose control

    Time frame: 6 months

    HbA1c, continuous glucose monitoring data

  2. 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.

  3. Diabetes quality of life

    Time frame: 6 months

    ESDQoL

  4. Adherence to trearment

    Time frame: 6 months

    ARMS-E questionnaire

  5. Diabetes treatment satisfaction

    Time frame: 6 months

    DTSQs, DTSQc questionnaire

Sponsors and collaborators

Lead sponsor

Hospital Arnau de Vilanova

Other

Collaborators

  • Institut Catala de Salut

Registry information

Acronym: POMA

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 28, 2023
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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