NCT05951140

Brief Summary

The topic of diet and physical activity are of great importance in the treatment of T2D. In the daily routine of a practice or clinic, a doctor has an average of eight minutes per patient, leaving little time for lifestyle issues (Irving et al. 2017). An individualised procedure requires more time and therefore more resources. Currently, an app can be programmed with evidence-based information so that it provides appropriate personalised behavioural recommendations via machine learning. The user gets direct feedback and can make a behavioural change himself. On the one hand, this approach allows better use of doctor-patient time and, on the other hand, the patient learns through positive reinforcement in such a way that his or her behaviour change is supported and reinforced in the longer term and potentially sustainably. The aim of this intervention pilot study within the scope of the EU-Horizon 2020 project is to investigate lifestyle support through a mobile app and wearables to improve lifestyle (personalised nutrition) and important metabolic outcomes in patients with type 2 diabetes or prediabetes. In addition, exploratory genetic and microbiome data will be explored to answer the question of personalisation of the recommendations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Oct 2020

Typical duration 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

Study Start

First participant enrolled

October 1, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 18, 2023

Completed
Last Updated

May 7, 2026

Status Verified

July 1, 2023

Enrollment Period

2.2 years

First QC Date

May 4, 2023

Last Update Submit

May 3, 2026

Conditions

Diabetes Mellitus, Type 2PreDiabetes

Outcome Measures

Primary Outcomes (2)

  • Improvement of Time In Range (TIR) by 5%

    Our primary objective is to increase the time in range (TIR) of the study participants by 5%

    12 Weeks

  • Improve eating behavior towards healthier choices

    Improve eating behaviour towards healthier choices during the intervention time

    12 Weeks

Secondary Outcomes (6)

  • Adherence to dietary recommendations of the app

    12 Weeks

  • Improvement of glycaemic metabolism

    12 Weeks

  • Reduction in sedentary time

    12 Weeks

  • Aproximation of the energy intake

    12 Weeks

  • Measurable change in the faecal microbiome

    12 Weeks

  • +1 more secondary outcomes

Study Arms (2)

Start-Group

EXPERIMENTAL

The Start-Group starts with the Protein-Application and wereables for 3 Months and afterwards uses only wereables for 6 Weeks.

Other: Usage of the PROTEIN-Application

Wait-Group

EXPERIMENTAL

The Wait-Group starts with 6 Weeks of using only wereables and afterwards adds the usage of the Protein-Application.

Other: Usage of the PROTEIN-Application

Interventions

Usage of the PROTEIN-ApplicationOTHER

Participants were randomly distributed into 2 groups: (1) Start-Group used the developed Application and wereables to investigate the effect of this support. Participants used the devices and the App for 3 Months followed by a 6-Weeks time of only using wereables and no app, to be able to compare the effects of the Application. (2) The Wait-Group used wereables for 6 Weeks before adding the Protein-App for also 3 Months.

Start-GroupWait-Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 18 years of age
  • Diabetes Type 2 or Prediabetes
  • BMI: 20-kg kg/m2
  • Android Smart Phone/ Tablet use
  • In good physical health
  • Able to provide written informed consent

You may not qualify if:

  • Severe endocrine, gastrointestinal, metabolic, cardiovascular, pulmonary, inflammatory or psychiatric disorder
  • Active or recent relevant cancer
  • Currently receiving treatment with Insulin
  • People with disordered eating (such as anorexia nervosa etc.)
  • Those who are not be able to provide written consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité Univesitätsmedizin Berlin

Berlin, State of Berlin, 12203, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Lazaros Gymnopoulos, Dr

    Information Technologies Institute, Centre for Research and Technology Hellas

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator, Univ. Prof. Dr. med.

Study Record Dates

First Submitted

May 4, 2023

First Posted

July 18, 2023

Study Start

October 1, 2020

Primary Completion

November 30, 2022

Study Completion

November 30, 2022

Last Updated

May 7, 2026

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)