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

Recruiting

• Conditions: Multiple Dose Insulin Therapy; Type 2 Diabetes Mellitus
• Interventions: Other: Personalized treatment

• Registration Number: NCT06148376
• Lead Sponsor: Hospital Arnau de Vilanova

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)

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 Timeline

• Study Start: 2023-11-01
• Study First Submitted: 2023-11-18
• Study First Submitted QC: 2023-11-18
• Study First Posted: 2023-11-28
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-20
• Last Update Posted: 2024-06-24
• Primary Completion: 2025-07-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 239

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MDI T2DM	Personalized treatment	Patients wit type 2 diabetes (T2DM) treated with multiple dose insulin therapy (MDI)

Primary Outcome Measures

Name	Time	Method
Percentage of patients whose prandial insulin is withdrawn	At 6 months from the inclusion	Percentage of patients whose prandial insulin is withdrawn

Secondary Outcome Measures

Name	Time	Method
Diabetes treatment satisfaction	6 months	DTSQs, DTSQc questionnaire
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.
Diabetes quality of life	6 months	ESDQoL
Adherence to trearment	6 months	ARMS-E questionnaire
Glucose control	6 months	HbA1c, continuous glucose monitoring data

Trial Locations

Locations (2)

Centres Atenció Primària Lleida, Alt Pirineu i Aran; 🇪🇸 Lleida, Spain

Hospital Universitari Arnau de Vilanova; 🇪🇸 Lleida, Spain