Clincosm LogoSign in Get a demo

POMA: Application of a Protocol of Personalyzed Medicine in Patients With Type 2 Diabetes Mellitus and Multiple Doses of Insulin in Routine Clincal Care

Sponsor
Hospital Arnau de Vilanova (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06148376
Collaborator
Institut Catala de Salut (Other)
239
Enrollment
25
Anticipated Duration (Months)

Study Details

Study Description

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 assesed after 6 months (CGM, HbA1c, quality of life (QoL)

Condition or Disease Intervention/Treatment Phase
  • Other: Personalized treatment

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
239 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Application of a Protocol of Personalyzed Medicine in Patients With Type 2 Diabetes Mellitus and Multiple Doses of Insulin in Routine Clincal Care
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2025
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
MDI T2DM

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

Other: Personalized treatment
Discontinue prandial insulin treatment

Outcome Measures

Primary Outcome Measures

  1. Precentage of patients whose prandial insulin is wthdrawn [At 6 months from the inclusion]

Secondary Outcome Measures

  1. Glucose control [6 months]

    HbA1c, continuous glucose monitoring data

  2. Number of severe hypoglycaemia events [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 [6 months]

    ESDQoL

  4. Adherence to trearment [6 months]

    ARMS-E questionnaire

  5. Diabetes treatment satisfaction [6 months]

    DTSQs, DTSQc questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Hospital Arnau de Vilanova
  • Institut Catala de Salut

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Marta Hernandez Garcia, MD PhD, Hospital Arnau de Vilanova
ClinicalTrials.gov Identifier:
NCT06148376
Other Study ID Numbers:
  • 23/823
First Posted:
Nov 28, 2023
Last Update Posted:
Nov 28, 2023
Last Verified:
Nov 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Nov 28, 2023