Diabetes Mellitus, Type 2PROTEINNCT05951140
Personalised Nutrition for Healthy Living
A study testing Usage of the PROTEIN-Application in people with Diabetes Mellitus, Type 2 and PreDiabetes, run by Prof. Dr. med. Andreas F. H. Pfeiffer at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, PreDiabetes
- What is being tested?
- Usage of the PROTEIN-Application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2020to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité Univesitätsmedizin Berlin
Berlin, State of Berlin, 12203
About this study
Official title: Personalised Nutrition for Healthy Living: PROTEIN
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.
Read the detailed description
An inadequate diet and increasing sedentary lifestyle are major contributors to the rise of non-communicable diseases. Individualized recommendations can lead to a healthier lifestyle. The scientific evidence of the effectiveness of health apps offering personalized recommendations is limited.
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. The Investigators want to asess whether the use of this mobile application that incorporates information of wearables (continuous glucose monitoring and fitness tracker), improves lifestyle and metabolic outcomes in patients with type 2 diabetes (T2D) or prediabetes. Our primary outcome is to improve time in range (TIR) by 5%.
It is a prospective randomized control pilot trial with an intervention period of 12 weeks. Participants will use the Protein app, a continuous glucose monitoring system (CGM) and an activity tracker to collect real world data to enable personalisation.
In order to identify the effect of the PROTEIN-Application, 300 participants with T2DM or prediabetes will be randomly allocated into two groups: the (1) start-group or the (2) wait-group. The start-group will use an activity tracker, a CGM and the PROTEIN app for 12 weeks followed by a six-week period without the app, but they will use the wearables. The wait-group will use an activity tracker and a CGM, but not the PROTEIN app for six weeks followed by a period of 12 weeks using the PROTEIN app. This study design allowed us to have a control group within the whole cohort and clearly see the influence of the PROTEIN app.
- Conditions
- Diabetes Mellitus, Type 2, PreDiabetes
- Being tested
- Usage of the PROTEIN-Application
- Medical subject headings
- Diabetes Mellitus, Type 2, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Start-Group | Experimental | The Start-Group starts with the Protein-Application and wereables for 3 Months and afterwards uses only wereables for 6 Weeks. Receives: 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. Receives: Other: Usage of the PROTEIN-Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: 12 Weeks
Improve eating behavior towards healthier choices
Improve eating behaviour towards healthier choices during the intervention time
Measured: 12 Weeks
Secondary outcomes (6)
Adherence to dietary recommendations of the app
Adherence to dietary recommendations of the PROTEIN-App
Measured: 12 Weeks
Improvement of glycaemic metabolism
Fasting glucose, HbA1c, HOMA-IR
Measured: 12 Weeks
Reduction in sedentary time
Reduction in sedentary time, defined as: Activity time through fitness trackers or increase in physical activity or increase in steps per day
Measured: 12 Weeks
Aproximation of the energy intake
Approximation of the energy intake (calorie intake and distribution of macronutrients) towards the agreed goals
Measured: 12 Weeks
Measurable change in the faecal microbiome
Measurable change in the faecal microbiome by extraction of DNA and its analysis to identify the relevant species of bacteria
Measured: 12 Weeks
Calculation of the Polygenic Risk Score
Calculation of the Polygenic Risk Score by Isolation of DNA from whole blood
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start1 Oct 2020
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. med. Andreas F. H. Pfeiffer
- Sponsor type
- University, hospital or other
- Collaborators
- European Union
- Responsible party
- Sponsor-investigator, Prof. Dr. med. Andreas F. H. Pfeiffer, Charite University, Berlin, Germany
- Investigators
- Lazaros Gymnopoulos, Dr, Study director, Information Technologies Institute, Centre for Research and Technology Hellas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05951140
- Sponsor's protocol ID
- PROTEIN
- Acronym
- PROTEIN
- Status last verified
- Jul 2023
- First submitted
- 4 May 2023
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lalama E, Csanalosi M, Kabisch S, Wilson-Barnes S, Gymnopoulos LP, Dimitropoulos K, Rouskas K, Anagnostis A, Oikonomidis I, Hadjileontiadis L, Cornelissen V, Hassapidou M, Pagkalos I, Balula Dias S, Hart K, Pfeiffer AFH. Effect of a Personalized Mobile App on Glucose Control in Adults With Prediabetes and Type 2 Diabetes: Exploratory Pilot Randomized Controlled Trial. JMIR Hum Factors. 2026 Jun 24;13:e87692. doi: 10.2196/87692.
PubMed 42342244
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalised Nutrition for Healthy Living: PROTEIN
- ClinicalTrials.gov ID
- NCT05951140
- Acronym / sponsor ID
- PROTEIN / PROTEIN
- Conditions
- Diabetes Mellitus, Type 2, PreDiabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Prof. Dr. med. Andreas F. H. PfeifferUniversity, hospital or other
- Collaborators
- European Union
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 18 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
An inadequate diet and increasing sedentary lifestyle are major contributors to the rise of non-communicable diseases. Individualized recommendations can lead to a healthier lifestyle. The scientific evidence of the effectiveness of health apps offering personalized recommendations is limited.
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. The Investigators want to asess whether the use of this mobile application that incorporates information of wearables (continuous glucose monitoring and fitness tracker), improves lifestyle and metabolic outcomes in patients with type 2 diabetes (T2D) or prediabetes. Our primary outcome is to improve time in range (TIR) by 5%.
It is a prospective randomized control pilot trial with an intervention period of 12 weeks. Participants will use the Protein app, a continuous glucose monitoring system (CGM) and an activity tracker to collect real world data to enable personalisation.
In order to identify the effect of the PROTEIN-Application, 300 participants with T2DM or prediabetes will be randomly allocated into two groups: the (1) start-group or the (2) wait-group. The start-group will use an activity tracker, a CGM and the PROTEIN app for 12 weeks followed by a six-week period without the app, but they will use the wearables. The wait-group will use an activity tracker and a CGM, but not the PROTEIN app for six weeks followed by a period of 12 weeks using the PROTEIN app. This study design allowed us to have a control group within the whole cohort and clearly see the influence of the PROTEIN app.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Start-Group | Experimental | Other: Usage of the PROTEIN-ApplicationThe Start-Group starts with the Protein-Application and wereables for 3 Months and afterwards uses only wereables for 6 Weeks. |
| Wait-Group | Experimental | Other: Usage of the PROTEIN-ApplicationThe Wait-Group starts with 6 Weeks of using only wereables and afterwards adds the usage of the Protein-Application. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥ 18 years of age
- Diabetes Type 2 or Prediabetes
- BMI: 20-kg kg/m2
- Android Smart Phone/ Tablet use
- In good physical health
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usage of the PROTEIN-ApplicationParticipants 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. | Other | Start-Group, Wait-Group |
Primary outcome
Improvement of Time In Range (TIR) by 5%
Time frame: 12 Weeks
Our primary objective is to increase the time in range (TIR) of the study participants by 5%
Improve eating behavior towards healthier choices
Time frame: 12 Weeks
Improve eating behaviour towards healthier choices during the intervention time
6 secondary outcomes
Adherence to dietary recommendations of the app
Time frame: 12 Weeks
Improvement of glycaemic metabolism
Time frame: 12 Weeks
Reduction in sedentary time
Time frame: 12 Weeks
Aproximation of the energy intake
Time frame: 12 Weeks
Measurable change in the faecal microbiome
Time frame: 12 Weeks
Calculation of the Polygenic Risk Score
Time frame: 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Derived from this study: PubMed 42342244Lalama E, Csanalosi M, Kabisch S, Wilson-Barnes S, Gymnopoulos LP, Dimitropoulos K, Rouskas K, Anagnostis A, Oikonomidis I, Hadjileontiadis L, Cornelissen V, Hassapidou M, Pagkalos I, Balula Dias S, Hart K, Pfeiffer AFH. Effect of a Personalized Mobile App on Glucose Control in Adults With Prediabetes and Type 2 Diabetes: Exploratory Pilot Randomized Controlled Trial. JMIR Hum Factors. 2026 Jun 24;13:e87692. doi: 10.2196/87692.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lazaros Gymnopoulos, Dr study director
Information Technologies Institute, Centre for Research and Technology Hellas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Usage of the PROTEIN-Application in people with Diabetes Mellitus, Type 2 and PreDiabetes, run by Prof. Dr. med. Andreas F. H. Pfeiffer at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of Time In Range (TIR) by 5% (time frame: 12 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05951140, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.