Diabetes mellitus type 2 Nutritional, Metabolic, Endocrine Non-insulin-dependent diabetes mellitus
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 30/06/2015: Patients: 1. Diabetes mellitus type 2 2. HbA1c level of 8.0 or above at the time of recruitment 3. Ability to informed consent 4. Fluency in the German language GPs: 1. General practitioner or internist, working as GP or practitioner with KV admission (Association of Statutory Health Insurance Physicians) Previous inclusion criteria from 10/01/2012 to 30/06/2015: Patients: 1. Diabetes mellitus type 2 2. HbA1c level of 8.1 or above at the time of recruitment 3. Ability to informed consent 4. Fluency in the German language GPs: 1. General practitioner or internist, working as GP or practitioner with KV admission (Association of Statutory Health Insurance Physicians) Original inclusion criteria until 10/01/2012: Patients: 1. Diabetes mellitus type 2 2. HbA1c level of 8.5 or above at the time of recruitment 3. Ability to informed consent 4. Fluency in the German language GPs: 1. General practitioner or internist, working as GP or practitioner with KV admission (Association of Statutory Health Insurance Physicians) 2. Participation on the Disease Management Program diabetes mellitus type 2
Exclusion criteria
Exclusion criteria: 1. Severe comorbidity 2. Life expectancy of less than 18 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome as of 10/01/2012 1. Change of HbA1c at 6, 12, 18, 24 months compared to HbA1c at baseline 2. HbA1c will be measured as routine examinaton, as the case may be within the scope of the German Disease Management Program performed at GP's medical practice Previous primary outcome 1. Change of HbA1c at 6, 12, 18, 24 months compared to HbA1c at baseline 2. HbA1c will be measured as routine examination within the scope of the German Disease Management Program performed at GP's medical practice | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome as of 10/01/2012 1. Patient's evaluation of patient-centeredness and life quality (PACIC-D, PEF-FB-9, BÄK-questionnaire, EQ-5D, PAID) 2. Cardiovascular risk prognosis 3. Pharmacotherapy Previous secondary outcome 1. Patient's evaluation of patient-centeredness and life quality (PACIC-D, PEF-FB-9, SF-36) 2. Cardiovascular risk prognosis 3. Pharmacotherapy | — |
Countries
Germany