Type 2 Diabetes Mellitus
Conditions
Brief summary
The purpose of the study is to compare the effect of telemedical coaching versus telemedical control on HbA1c, weight, BMI, blood pressure, blood lipids, medication, nutrition, physical activity and quality of life in type 2 diabetes patients with poor glycaemic control.
Interventions
BEHAVIORALTelemedical coaching
OTHERTelemedicine
Sponsors
German Institute for Telemedicine and Health Promotion
West German Center of Diabetes and Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* type 2 diabetes mellitus * hemoglobin A1c (HbA1c) \>7.5% * at leat two different antidiabetic drugs * body mass index \>27kg/m2
Exclusion criteria
* acute infections * diagnosed chronic diseases other than type 2 diabetes and hypertension, e.g. cancer, chronic obstructive pulmonary disease (COPD), asthma, dementia, chronic gut diseases, psychoses, liver cirrhosis, (macro-) nephropathy, kidney insufficiency with glomerular filtration rate (eGFR) \< 30ml / min / 1.73 m2 * acute chemotherapy or chronic cortisol treatment * smoking cessation for less than 3 months and or planned smoking cessation during study * known intolerance of any ingredient of Almased (especially soy protein) * pregnancy or breast feeding, lack of contraception (women) * other study participation in the last 6 months prior to study start
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 12 months | Difference in HbA1c (at end of study vs. baseline) between the groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| antidiabetic medication | 12 months | Difference in antidiabetic medication (at end of study vs. baseline) between the groups |
| Cardiovascular risk parameters (blood pressure, blood lipids) | 12 months | Difference in cardiovascular risk parameters (i.e. blood pressure, blood lipids) (at end of study vs. baseline) between the groups |
| weight | 12 months | Difference in weight (at end of study vs. baseline) between the groups |
| nutrition | 12 months | Difference in nutrition (at end of study vs. baseline) between the groups |
| quality of life | 12 months | Difference in quality of life (at end of study vs. baseline) between the groups |
| physical activity (step count) | 12 months | Difference in physical activity (at end of study vs. baseline) between the groups |
Countries
Germany
Outcome results
None listed