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

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

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

Conditions
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Type 2 Diabetes Mellitus, Multiple Dose Insulin Therapy

Intervention / Treatment
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* Other: Personalized treatment


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MDI T2DM<br>Patients wit type 2 diabetes (T2DM) treated with multiple dose insulin therapy (MDI) | Other: Personalized treatment<br>* Discontinue prandial insulin treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Precentage of patients whose prandial insulin is wthdrawn |  | At 6 months from the inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose control | HbA1c, continuous glucose monitoring data | 6 months | 
| 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 | 
| Diabetes quality of life | ESDQoL | 6 months | 
| Adherence to trearment | ARMS-E questionnaire | 6 months | 
| Diabetes treatment satisfaction | DTSQs, DTSQc questionnaire | 6 months |