Application of a Protocol of Personalized Medicine in Patients With Type 2 Diabetes Mellitus and Multiple Doses of Insulin in Routine Clinical Care
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 239
- Locations
- 2
- Primary Endpoint
- Percentage of patients whose prandial insulin is withdrawn
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
MDI T2DM
Patients wit type 2 diabetes (T2DM) treated with multiple dose insulin therapy (MDI)
Intervention: Personalized treatment (Other)
Outcomes
Primary Outcomes
Percentage of patients whose prandial insulin is withdrawn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Percentage of patients whose prandial insulin is withdrawn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
- Adherence to trearment(6 months)
- Diabetes treatment satisfaction(6 months)
- Number of severe hypoglycaemia events(6 months)
- Diabetes quality of life(6 months)
- Glucose control(6 months)
Investigators
Marta Hernandez Garcia
MD PhD
Hospital Arnau de Vilanova