NCT03675919

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,163

participants targeted

Target at P75+ for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Sep 2018

Longer than P75 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

September 15, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 18, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

January 20, 2023

Status Verified

January 1, 2023

Enrollment Period

3 years

First QC Date

September 11, 2018

Last Update Submit

January 19, 2023

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

  • HbA1c change

    estimated treatment difference between groups of HbA1c change (in T2DM patients with diabetes duration of ≥ 5 years)

    12 months

  • remission rate

    number of participants with an HBA1c \<6.5% (in T2DM patients with diabetes duration of \< 5 years)

    12 months

Secondary Outcomes (14)

  • fasting blood glucose change

    12 months

  • weight change

    12 months

  • body mass index change

    12 months

  • systolic blood pressure change

    12 months

  • diastolic blood pressure change

    12 months

  • +9 more secondary outcomes

Study Arms (2)

Control group

ACTIVE COMPARATOR

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.

Device: ScaleDevice: Step counterOther: Access to the online portal

TeLIPro group

EXPERIMENTAL

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.

Device: ScaleDevice: Step counterDevice: Blood glucose meter with test stripesOther: Access to the online portalOther: Telemedical coaching

Interventions

ScaleDEVICE

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

Control groupTeLIPro group
Step counterDEVICE

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

Control groupTeLIPro group
Blood glucose meter with test stripesDEVICE

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

TeLIPro group
Access to the online portalOTHER

self-monitoring of health parameters

Control groupTeLIPro group
Telemedical coachingOTHER

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

TeLIPro group

Eligibility Criteria

Age25 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes mellitus
  • body mass index of et least 27 kg/m2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West German Centre of Diabetes and Health

Düsseldorf, 40591, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Weights and Measures

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Bernd Altpeter

    Deutsches Institut für Telemedizin und Gesundheitsförderung

    STUDY CHAIR

  • Sibel Altin

    AOK Rheinland/Hamburg

    STUDY CHAIR

  • Andrea Icks, PhD

    Deusches Diabetes Zentrum

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

September 11, 2018

First Posted

September 18, 2018

Study Start

September 15, 2018

Primary Completion

September 21, 2021

Study Completion

September 30, 2022

Last Updated

January 20, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)