Digital, Blended Lifestyle Intervention for Type 2 Diabetes Remission

NCT05346614 | Unknown DMC

• 1 other identifier: NL77688.056.21
• Study Type: interventional
• Target: 410
• Locations: 1 country
• Sites: 4

Brief 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

Outcome Measures

Primary Outcomes (1)

• Rate of diabetes remission

  Percentage of patients achieving complete diabetes remission. Diabetes remission rates amongst the active intervention group will be reported as the number of participants who have achieved fasting glucose \< 7 mmol/L or HbA1c \< 6.5% (48 mmol/mol) on two separate occasions 6 months apart, and glucose-lowering therapy has been stopped.

  1 year

Secondary Outcomes (7)

• Rates of improved glycaemic control

  Will be reported at all follow-up moments (6 months, 1 year, and 2 years)

• Blood lipids

  Will be reported at all follow-up moments (6 months, 1 year, and 2 years)

• Weight loss

  Will be reported at all follow-up moments (6 months, 1 year, and 2 years)

• Remission versus diabetype

  Will be reported at all follow-up moments (6 months, 1 year, and 2 years)

• Cost effectiveness

  Will be reported at all follow-up moments (6 months, 1 year, and 2 years)

Study Arms (2)

Active lifestyle intervention

EXPERIMENTAL

Individuals in the active intervention group will undergo diabetyping (diabetes type 2 phenotyping: glucose, and C-peptide responses to a glucose challenge). Based on the diabetype, individuals will receive recommendations to follow either a calorie-restricted (500kcal deficit minimum) low carbohydrate or a modified Mediterranean diet for a period of 18 weeks (total intervention is 24 weeks). Secondly, individuals will follow a personalized exercise program. Guidance and coaching (individual and small group) will be given via mobile app and digital platform. Individuals will receive real-time feedback based on their diet, exercise, and glucose levels (via continuous glucose monitoring for 4 weeks). Medications will be slowly withdrawn over the intervention period, with a focus on the first phase of the intervention.

Behavioral: Lifestyle intervention

Usual care group

NO INTERVENTION

Individuals in the usual care group will receive standard diabetes care.

Interventions

Lifestyle intervention BEHAVIORAL

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.

Active lifestyle intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diabetes: Diagnosis of T2DM without physician defined end-organ failure
• BMI: 25 to 45 kg/m²
• Age: 18 to 75 years
• Most recent HbA1c value should be greater than 6.0% (\>43 mmol/mol); if less than 6.5% (\<48 mmol/mol), individuals should still be receiving anti-diabetic medication
• Tech-savvy (patients are required to be able to fully use smartphone or tablet)
• Display interest and motivation to enroll in a digital, lifestyle intervention for diabetes

You may not qualify if:

• Weight loss of more than five kg or greater than 10% within the past six months
• Serious co-morbidities, for example, a severe form of chronic obstructive pulmonary disease (Gold III or IV), bariatric surgery, heart failure (classes 2-4) kidney failure, or another medically determined end-stage organ failure
• Substance abuse
• Learning difficulties limiting the participation in a digital health intervention and or limiting the comprehension of trial goals or coaching curriculum.
• Current treatment with anti-obesity drugs
• Pregnancy, consideration of pregnancy within the study period, lactation or having given birth within the previous nine months
• Hospital admission for depression
• Major psychiatric disorder (e.g., schizophrenia, bipolar disorder) or use of antipsychotic drugs.
• Currently uncontrolled or eating disorder or purging behavior
• Type 1 diabetes
• History of keto-acidosis
• Myocardial infarction, stroke, angina, or coronary insufficiency within the previous six months
• Diabetic retinopathy requiring treatment
• Creatinine \> 2.0 mg·dL-1 or \> 152.5 µmol·L-1
• Urinary albumin \> 1 g·dL-1 or \> 10 g·L-1

Sponsors & Collaborators

• Ancora Health B.V.: lead
• University of Groningen: collaborator
• Universiteit Leiden: collaborator
• TNO: collaborator

Study Sites (4)

St. Anna Ziekenhuis

Eindhoven, Limburg, Netherlands

Location

Center Medische Kwartier Eindhoven

Eindhoven, North Brabant, 5611 NV, Netherlands

Location

Huisartsenpraktijk Zonneoord

The Hague, South Holland, 2544 KM, Netherlands

Location

Haga Ziekenhuis

The Hague, South Holland, 2545 AA, Netherlands

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Suzan Wopereis, PhD

  TNO

  PRINCIPAL INVESTIGATOR

• Maarten van Aken, MD PhD

  Haga Ziekenhuis

  PRINCIPAL INVESTIGATOR

• Elly Vogelzang, MD

  Center Medische Kwartier Eindhoven

  PRINCIPAL INVESTIGATOR

• Janet Kist, MD

  Huisartsenpraktijk Zonneoord

  PRINCIPAL INVESTIGATOR

• Jan Hoogsteen, MD

  Ancora Health

  PRINCIPAL INVESTIGATOR

• Rimke Vos, PhD

  Department of Public Health and Primary Care / LUMC-Campus Den Haag

  PRINCIPAL INVESTIGATOR

Central Study Contacts

José Castela Forte, MSc.

CONTACT

+316 28218360; Jose@Ancora.health

Sarah Mount, PhD

CONTACT

Sarah@Ancora.health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded to the treatment allocations. It is not possible to blind participants or care providers who will be providing the intervention, as this is a lifestyle intervention. Controls receive usual care.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This a randomized intervention study. Subjects will be randomly allocated using a 5:1 ratio between the control and intervention groups.

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: April 26, 2022
• Study Start: October 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: March 1, 2025
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Undecided.
• Access Criteria: Undecided.

Locations

NL (4)