Clinical trial NCT03675919: TeLIPro Health Program - Active With Diabetes
Official title: The Telemedical Lifestyle Intervention Program TeLIPro (TeLIPro Health Program - Active With Diabetes)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus, Type 2
Lead sponsor: West German Center of Diabetes and Health
Sponsor class: OTHER
Collaborators: name: AOK Rheinland/Hamburg
name: German Institute for Telemedicine and Health Promotion
name: German Diabetes Center
First posted: 2018-09-18
Enrollment: 1163
Sex: ALL
Minimum age (years): 25
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: HbA1c change
timeFrame: 12 months
measure: remission rate
timeFrame: 12 months
Secondary outcomes:
measure: fasting blood glucose change
timeFrame: 12 months
measure: weight change
timeFrame: 12 months
measure: body mass index change
timeFrame: 12 months
measure: systolic blood pressure change
timeFrame: 12 months
measure: diastolic blood pressure change
timeFrame: 12 months
measure: total cholesterol change
timeFrame: 12 months
measure: high-density lipoprotein (HDL) cholesterol change
timeFrame: 12 months
measure: low-density lipoprotein (LDL) cholesterol change
timeFrame: 12 months
measure: triglyceride change
timeFrame: 12 months
measure: number of steps
timeFrame: 12 months
measure: antidiabetic medication change
timeFrame: 12 months
measure: diabetes-specific treatment costs
timeFrame: 12 months
measure: inpatient costs
timeFrame: 12 months
measure: outpatient costs
timeFrame: 12 months
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: West German Centre of Diabetes and Health
Study officials:
affiliation: Deutsches Institut für Telemedizin und Gesundheitsförderung
name: Bernd Altpeter
role: STUDY_CHAIR
affiliation: AOK Rheinland/Hamburg
name: Sibel Altin
role: STUDY_CHAIR
affiliation: Deusches Diabetes Zentrum
name: Andrea Icks, PhD
role: STUDY_CHAIR
References: