NCT07661381

Brief Summary

The aim of this study is to evaluate the feasibility and effectiveness of a remote personalised lifestyle program in individuals with T2D. Outcomes will be assessed at the start and after 3, 6, and 12 months with two follow-up measurements (18 and 24 months) to determine whether participation in this re-mote lifestyle program leads to improvements in health and diabetes-related outcomes.

Trial Health

63
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Trial Health Score

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

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
27mo left

Started Sep 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 22, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

June 25, 2026

Status Verified

June 1, 2026

Enrollment Period

2.3 years

First QC Date

June 16, 2026

Last Update Submit

June 22, 2026

Conditions

Diabetes Type 2

Keywords

Lifestyle interventionArtificial intelligenceRemote studyDietary intakeContinuous glucose monitoringLifestyle coach

Outcome Measures

Primary Outcomes (1)

  • Change in HbA1c levels

    The main study parameter is the impact of the lifestyle program on blood glucose levels, as evaluated by changes in HbA1c levels at the beginning of the study and after 3, 6 and 12 months.

    From the beginning of the study to the end of the study at 12 months

Secondary Outcomes (10)

  • Change in body weight

    From the beginning of the study to the end of the study (12 months), including the two follow-up measurements at 18 and 24 months

  • Change in blood pressure

    From the beginning of the study to the end of the study (12 months)

  • Change in medication use

    From the beginning of the study to the end of the study (12 months), including the two follow-up measurements at 18 and 24 months

  • Change in waist and hip circumference

    From the beginning of the study to the end of the study (12 months), including the two follow-up measurements at 18 and 24 months

  • Change in habitual dietary intake assessed with the Nutri+ instrument

    From the beginning of the study to the end of the study (12 months), including the two follow-up measurements at 18 and 24 months

  • +5 more secondary outcomes

Other Outcomes (1)

  • Socio-demographic characteristics

    At baseline

Study Arms (3)

Arm 1

ACTIVE COMPARATOR

Lifestyle program (control group)

Behavioral: Lifestyle program

Arm 2

EXPERIMENTAL

Lifestyle program + coach

Device: Lifestyle program + coach

Arm 3

EXPERIMENTAL

Lifestyle program + coach + CGM

Device: Lifestyle program + coach + CGM

Interventions

Lifestyle programBEHAVIORAL

Participants are asked to work on improving their lifestyle. They have access to an online community throughout the study, where they can get in touch with other participants within their research-arm. Participants are also asked to attend twelve online group sessions, during which a lifestyle coach will explain more about nutrition, physical activity, sleep, stress, social aspects, challenges and setbacks, and long-term maintenance.

Arm 1
Lifestyle program + coachDEVICE

Idem to arm one, supplemented with a virtual AI lifestyle coach. The AI lifestyle coach can process all the information about the participant that was provided at baseline. This information is compiled into a participant profile, which the AI lifestyle coach uses to initiate personalised conversations with the participant. During these conversations, the AI lifestyle coach supports the participant through a structured coaching cycle of three phases: preparation (reflecting on what matters and co-creating a personalised plan), coaching (day-to-day support to work on the plan), and evaluation (reviewing progress and adjusting or renewing the plan). The coach draws on an evidence-based knowledge base of lifestyle interventions to recommend appropriate, evidence-informed actions. The use of the AI lifestyle coach is an additional topic to the online group sessions.

Arm 2
Lifestyle program + coach + CGMDEVICE

Idem to arm two, but participants are also asked to wear an CGM four times for two consecutive weeks. The glucose values information collected by the CGM is used by the AI lifestyle coach to make conversations with the participant even more personalized. The use of CGMs is an additional topic to the online group sessions.

Arm 3

Eligibility Criteria

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

You may qualify if:

  • Age: ≥18 years
  • HbA1c: ≥53 mmol/mol (7 - 12%)
  • Signed informed consent form and willing to comply with the study procedures
  • Persons who are naïve for participation in a lifestyle program for the past two years
  • Being digitally competent
  • Mastering the Dutch language
  • Accepting the confidential use and storage of anonymised data for analysis and publication (at least 15 years)

You may not qualify if:

  • Medication use: any other glucose-lowering medication than metformin
  • Comorbidities or medical conditions requiring a special diet that conflicts with the study
  • Circumstances that lead to unreliable HbA1c values, such as blood donation
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Twente

Enschede, Overijssel, 7500 AE, Netherlands

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineMonitoring, PhysiologicInvestigative Techniques

Study Officials

  • Goos D. Laverman, Prof. Dr.

    University of Twente

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lotte G.P. Peters, MSc

CONTACT

+31534891403lotte.peters@utwente.nl

Anouk Middelweerd, Dr

CONTACT

+31534897486a.middelweerd@utwente.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants are randomly assigned to one of three intervention arms.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

June 16, 2026

First Posted

June 22, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

June 25, 2026

Record last verified: 2026-06

Locations

NL(1)