Digital, Blended Lifestyle Intervention for Type 2 Diabetes Remission (IBIDEM)
Diabetes Mellitus, Type 2
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Cancer requiring treatment in the past five years, with the exception of non-melanoma skin cancer
- Chronic infectious disease requiring ongoing treatment
- Other chronic diseases or conditions likely to limit lifespan to less than six years
- Severe visual impairment or other impairment preventing interaction with digital content
- Non-English or Non-Dutch speaking
- Excessive alcohol intake (acute or chronic) defined as the average consumption of three or more alcohol-containing beverages daily or consumption of more than 14 alcoholic beverages per week
- Cholelithiasis or biliary dysfunction
- Use of an insulin pump
- Participation in diabetes therapy within the preceding three years; participation in concurrent weight management or interventional research protocol,
- Untreated thyroid disease,
- Requirement of a prescribed medical diet
- A recent on-record estimated glomerular filtration rate of less than 30 mL/min per 1.732 m²
- Incapacitated patients, and thus unable to fully participate in the trial.
- uncontrolled blood pressure (SBP > 170 mmHg and/or DBP > 100 mmHg)
- For nutritional ketosis specifically: impaired hepatic function (Bilirubin >2 mg·dL-1 or >34.2 µmol·L-1, Albumin < 3.5 g·dL-1 or <35 g·L-1)
Sites / Locations
- St. Anna Ziekenhuis
- Center Medische Kwartier Eindhoven
- Huisartsenpraktijk Zonneoord
- Haga Ziekenhuis
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Active lifestyle intervention
Usual care group
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.
Individuals in the usual care group will receive standard diabetes care.