Multiple Dose Insulin Therapy, Type 2 Diabetes Mellitus
Conditions
Keywords
Type 2 Diabetes Meliitus, Multiple dose insulin therapy, personalized medicine
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.
Interventions
Discontinue prandial insulin treatment
Sponsors
Hospital Arnau de Vilanova
Institut Catala de Salut
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients whose prandial insulin is withdrawn | At 6 months from the inclusion | Percentage of patients whose prandial insulin is withdrawn |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glucose control | 6 months | HbA1c, continuous glucose monitoring data |
| 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 |
| Diabetes treatment satisfaction | 6 months | DTSQs, DTSQc questionnaire |
Countries
Spain
Contacts
PRINCIPAL_INVESTIGATORMarta Hernández, MD PhD
Hospital Arnau de Vilanova
Outcome results
None listed