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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

239 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-01

Study Completion Date

2025-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Type 2 Diabetes Mellitus Multiple Dose Insulin Therapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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MDI T2DM

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

Personalized treatment

Intervention Type OTHER

Discontinue prandial insulin treatment

Interventions

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Personalized treatment

Discontinue prandial insulin treatment

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No