Digital, Blended Lifestyle Intervention for Type 2 Diabetes Remission

Summary

410 Dutch type 2 diabetes patients will be randomized using a 5:1 ratio to intervention group versus control, to a lifestyle intervention program given via a mobile application and digital platform. Active participants will undergo diabetyping, where blood glucose and c-peptide responses to a glucose challenge are measured, and be recommended to follow a calorie-restricted (minimum 500 kcal deficit) low-carbohydrate, or restricted carbohydrate (120g) Mediterranean diet and customized exercise program for a period of 24 weeks. Individuals will then be followed for a period of 2 years following the intervention.

Conditions

• Diabetes Mellitus, Type 2

Interventions

BEHAVIORAL

Lifestyle intervention

Lifestyle coaching will be given on a digital app-based platform. Individuals will receive real-time feedback via a smart scale, activity monitor, and continuous glucose monitor (first 4 weeks, longer if required). Coaching will be focused on gradual behavior change, assisted by digital nudges, one-on-one, and small group coaching sessions. Coaching will include education regarding lifestyle to improve health literacy with respect to diet and diabetes management. Additionally, coaches will guide participants in the implementation of individualized diet and exercise program with varying levels of carbohydrate restriction and caloric deficit.

Sponsors & Collaborators

• University of Groningen

  collaborator OTHER

• Universiteit Leiden

  collaborator OTHER

• TNO

  collaborator OTHER

• Ancora Health B.V.

  lead INDUSTRY

Principal Investigators

• Suzan Wopereis, PhD · TNO

• Maarten van Aken, MD PhD · Haga Ziekenhuis

• Elly Vogelzang, MD · Center Medische Kwartier Eindhoven

• Janet Kist, MD · Huisartsenpraktijk Zonneoord

• Jan Hoogsteen, MD · Ancora Health

• Rimke Vos, PhD · Department of Public Health and Primary Care / LUMC-Campus Den Haag

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-10-01

Primary Completion

2024-06-01

Completion

2025-03-01

Countries

• Netherlands

Study Locations