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| Name | Class |
|---|---|
| Institut Catala de Salut | OTHER_GOV |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MDI T2DM | Patients wit type 2 diabetes (T2DM) treated with multiple dose insulin therapy (MDI) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personalized treatment | Other | Discontinue prandial insulin treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients whose prandial insulin is withdrawn | Percentage of patients whose prandial insulin is withdrawn | At 6 months from the inclusion |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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All the patients in our territory treated with multiple dose insulin therapy without exclusion criteria are elegible to participate.
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| Name | Affiliation | Role |
|---|---|---|
| Marta Hernández, MD PhD | Hospital Arnau de Vilanova | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Arnau de Vilanova | Lleida | 25198 | Spain | |||
| Centres Atenció Primària Lleida, Alt Pirineu i Aran |
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| 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 |
| Lleida |
| Spain |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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