Diabetes Mellitus, Type 2
Conditions
Keywords
Diabetes Mellitus, Type 2
Brief summary
In a randomized-controlled trial the hypothesis should be tested that the Telemedical Lifestyle Intervention Program TeLIPro could significantly improve HbA1c (primary outcome), body weight and composition, cardiovascular risk factors, quality of life, eating behavior, and medication demand (secondary outcomes) in type 2 diabetes mellitus (T2DM) patients.
Detailed description
T2DM patients, assured at the health insurance AOK Rhineland / Hamburg will be randomized into two parallel groups. In addition to routine care both groups will be provided a scale as well as a step counter and access to a secured online portal. The TeLIPro group will additionally got a glucose meter with test stripes fpr self-monitoring of blood glucose and telemedical coaching. Participants of both groups will enter their anthropometric and metabolic data into a database on quarterly basis. In addition, the costs for diabetes-specific treatment, inpatient and outpatient treatment costs and drug costs will be analyzed on the basis of the routine data of the AOK Rhineland / Hamburg. Patient preference for type 2 diabetes intervention will be recorded using Discrete Choice Experiment (DCE) questionnaires at the beginning of the program and at the end of the intervention. As part of the development and validation of the DCE, focus groups are used to determine the DCE attributes. In addition, focus groups should also be used during the data collection in order to obtain additional information on patient preferences by means of qualitative analysis.
Interventions
DEVICEScale
self-monitoring of body weight; with automatic data transfer into the personalized and secured online portal
DEVICEStep counter
self-monitoring of physical activity; with automatic data transfer into the personalized and secured online portal
DEVICEBlood glucose meter with test stripes
self-monitoring of blood glucose; with automatic data transfer into the personalized and secured online portal
OTHERAccess to the online portal
self-monitoring of health parameters
OTHERTelemedical coaching
regular telephone calls providing information about T2DM, healthy lifestyle, low-carbohydrate diet and physical activity
Sponsors
AOK Rheinland/Hamburg
German Institute for Telemedicine and Health Promotion
German Diabetes Center
West German Center of Diabetes and Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Intervention model description
randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
25 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes mellitus * body mass index of et least 27 kg/m2
Exclusion criteria
* acute infections * chronic diseases other than type 2 diabetes and hypertension (e.g., cancer, chronic obstructive pulmonary disease, asthma, dementia, chronic gut diseases, psychoses, liver cirrhosis, macronephropathy/nephropathy, kidney insufficiency with glomerular filtration rate \<30 ml/min/1.73 m2) * acute chemotherapy or chronic cortisol treatment * smoking cessation for \<3 months and/or planned smoking cessation during study * pregnancy or breast-feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c change | 12 months | estimated treatment difference between groups of HbA1c change (in T2DM patients with diabetes duration of ≥ 5 years) |
| remission rate | 12 months | number of participants with an HBA1c \<6.5% (in T2DM patients with diabetes duration of \< 5 years) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| fasting blood glucose change | 12 months | estimated treatment difference between groups of fasting blood glucose change |
| weight change | 12 months | estimated treatment difference between groups of weight change |
| body mass index change | 12 months | estimated treatment difference between groups of body mass index change |
| systolic blood pressure change | 12 months | estimated treatment difference between groups of systolic blood pressure change |
| high-density lipoprotein (HDL) cholesterol change | 12 months | estimated treatment difference between groups of high-density lipoprotein (HDL) cholesterol change |
| low-density lipoprotein (LDL) cholesterol change | 12 months | estimated treatment difference between groups of low-density lipoprotein (LDL) cholesterol change |
| diastolic blood pressure change | 12 months | estimated treatment difference between groups of diastolic blood pressure change |
| number of steps | 12 months | estimated treatment difference between groups of number of steps |
| antidiabetic medication change | 12 months | estimated treatment difference between groups of antidiabetic medication change |
| diabetes-specific treatment costs | 12 months | estimated treatment difference between groups of diabetes-specific treatment costs |
| inpatient costs | 12 months | estimated treatment difference between groups of inpatient costs |
| outpatient costs | 12 months | estimated treatment difference between groups of outpatient costs |
| triglyceride change | 12 months | estimated treatment difference between groups of triglyceride change |
| total cholesterol change | 12 months | estimated treatment difference between groups of total cholesterol change |
Countries
Germany
Outcome results
None listed