TeLIPro Health Program - Active With Diabetes

NCT ID: NCT03675919

Last Updated: 2023-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1163 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-15

Study Completion Date

2022-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus, Type 2

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized controlled trial
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control group

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.

Group Type ACTIVE_COMPARATOR

Scale

Intervention Type DEVICE

self-monitoring of body weight; with automatic data transfer into the personalized and secured online portal

Step counter

Intervention Type DEVICE

self-monitoring of physical activity; with automatic data transfer into the personalized and secured online portal

Access to the online portal

Intervention Type OTHER

self-monitoring of health parameters

TeLIPro group

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.

Group Type EXPERIMENTAL

Scale

Intervention Type DEVICE

self-monitoring of body weight; with automatic data transfer into the personalized and secured online portal

Step counter

Intervention Type DEVICE

self-monitoring of physical activity; with automatic data transfer into the personalized and secured online portal

Blood glucose meter with test stripes

Intervention Type DEVICE

self-monitoring of blood glucose; with automatic data transfer into the personalized and secured online portal

Access to the online portal

Intervention Type OTHER

self-monitoring of health parameters

Telemedical coaching

Intervention Type OTHER

regular telephone calls providing information about T2DM, healthy lifestyle, low-carbohydrate diet and physical activity

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Scale

self-monitoring of body weight; with automatic data transfer into the personalized and secured online portal

Intervention Type DEVICE

Step counter

self-monitoring of physical activity; with automatic data transfer into the personalized and secured online portal

Intervention Type DEVICE

Blood glucose meter with test stripes

self-monitoring of blood glucose; with automatic data transfer into the personalized and secured online portal

Intervention Type DEVICE

Access to the online portal

self-monitoring of health parameters

Intervention Type OTHER

Telemedical coaching

regular telephone calls providing information about T2DM, healthy lifestyle, low-carbohydrate diet and physical activity

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

25 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AOK Rheinland/Hamburg

INDUSTRY

Sponsor Role collaborator

German Institute for Telemedicine and Health Promotion

OTHER

Sponsor Role collaborator

German Diabetes Center

OTHER

Sponsor Role collaborator

West German Center of Diabetes and Health

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Stephan Martin

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bernd Altpeter

Role: STUDY_CHAIR

Deutsches Institut für Telemedizin und Gesundheitsförderung

Sibel Altin

Role: STUDY_CHAIR

AOK Rheinland/Hamburg

Andrea Icks, PhD

Role: STUDY_CHAIR

Deusches Diabetes Zentrum

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

West German Centre of Diabetes and Health

Düsseldorf, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TeLIPro

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Mastering Diabetes Study
NCT04454957 ACTIVE_NOT_RECRUITING NA