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

Type 2 Diabetes Mellitus Clinical Trial

— POMA  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06148376
• Other study ID #: 23/823
• Status: Not yet recruiting
• Start date: December 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: Hospital Arnau de Vilanova
• Contact: Marta Hernández, MD PhD
• Phone: 973705183
• Email: martahernandezg[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 239
• Est. completion date: December 31, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Other:
• Personalized treatment
Discontinue prandial insulin treatment

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Arnau de Vilanova	Institut Catala de Salut

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Precentage of patients whose prandial insulin is wthdrawn		At 6 months from the inclusion
Secondary	Glucose control	HbA1c, continuous glucose monitoring data	6 months
Secondary	Number of severe hypoglycaemia events	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
Secondary	Diabetes quality of life	ESDQoL	6 months
Secondary	Adherence to trearment	ARMS-E questionnaire	6 months
Secondary	Diabetes treatment satisfaction	DTSQs, DTSQc questionnaire	6 months