TeLIPro Health Program - Active With Diabetes

West German Center of Diabetes and Health

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Device: Step counter; Other: Access to the online portal; Device: Scale; Device: Blood glucose meter with test stripes; Other: Telemedical coaching

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03675919

TeLIPro

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,163 patients

Sex: All

Ages: 25 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,163 participants in 2 patient groups

Control group

Active Comparator group

Description:

The control group will be provided a scale, a step counter as well as access to the online portal and will remain in routine care.

Treatment:

Device: Scale

Other: Access to the online portal

Device: Step counter

TeLIPro group

Experimental group

Description:

The TeLIPro group will be provided a scale, a step counter, a blood glucose meter with test stripes as well as access to the online portal and will get telemedical coaching.

Treatment:

Other: Telemedical coaching

Device: Blood glucose meter with test stripes

Device: Scale

Other: Access to the online portal

Device: Step counter