TeLIPro Health Program - Active With Diabetes

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Device: Scale; Device: Step counter; Other: Access to the online portal; Device: Blood glucose meter with test stripes; Other: Telemedical coaching

• Registration Number: NCT03675919
• Lead Sponsor: West German Center of Diabetes and Health

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.

Study Timeline

• Study First Submitted: 2018-09-11
• Study Start: 2018-09-15
• Study First Submitted QC: 2018-09-17
• Study First Posted: 2018-09-18
• Primary Completion: 2021-09-21
• Study Completion: 2022-09-30
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-19
• Last Update Posted: 2023-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1163

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TeLIPro group	Scale	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.
Control group	Scale	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.
Control group	Access to the online portal	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.
TeLIPro group	Blood glucose meter with test stripes	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.
Control group	Step counter	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.
TeLIPro group	Step counter	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.
TeLIPro group	Access to the online portal	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.
TeLIPro group	Telemedical coaching	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
diabetes-specific treatment costs	12 months	estimated treatment difference between groups of diabetes-specific treatment costs
total cholesterol change	12 months	estimated treatment difference between groups of total cholesterol change
number of steps	12 months	estimated treatment difference between groups of number of steps
weight change	12 months	estimated treatment difference between groups of weight change
diastolic blood pressure change	12 months	estimated treatment difference between groups of diastolic blood pressure change
triglyceride change	12 months	estimated treatment difference between groups of triglyceride change
antidiabetic medication change	12 months	estimated treatment difference between groups of antidiabetic medication change
inpatient costs	12 months	estimated treatment difference between groups of inpatient costs
fasting blood glucose change	12 months	estimated treatment difference between groups of fasting blood glucose 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
low-density lipoprotein (LDL) cholesterol change	12 months	estimated treatment difference between groups of low-density lipoprotein (LDL) cholesterol change
outpatient costs	12 months	estimated treatment difference between groups of outpatient costs
high-density lipoprotein (HDL) cholesterol change	12 months	estimated treatment difference between groups of high-density lipoprotein (HDL) cholesterol change

Trial Locations

Locations (1)

West German Centre of Diabetes and Health; 🇩🇪 Düsseldorf, Germany