Digital, blended lifestyle intervention program for remission and improved management of type 2 diabetes

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 410

Inclusion Criteria

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

Exclusion Criteria

- Serious co-morbidities, for example, a severe form of chronic obstructive
pulmonary disease (Gold III or IV), heart failure (classes 2-4) kidney failure
(eGFR / MDRD) <45 units, or other medically determined end-stage organ failure,
on active donor list
- Myocardial infarction, stroke, angina, or coronary insufficiency within the
previous six months
- Requirement of a prescribed medical diet
- Weight loss of more than five kg or greater than 10% within the past six
months
- Participation in diabetes therapy within the preceding three years;
participation in concurrent weight management or interventional research
protocol,
- Untreated thyroid disease,
- 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
- Incapacitated patients, and thus unable to fully participate in the trial.
- Uncontrolled blood pressure (SBP > 170 mmHg and/or DBP > 100 mmHg)
- Use of an insulin pump
- Type 1 diabetes
- Substance abuse
- Non-English or Non-Dutch speaking
- Cancer requiring treatment in the past five years, with the exception of
non-melanoma skin cancer
- Chronic infectious disease requiring ongoing treatment
- Diabetic retinopathy requiring treatment
Pregnancy, consideration of pregnancy within the study period,
lactation, or having given birth within the previous nine months
- History of keto-acidosis
- Current treatment with anti-obesity drugs
- Eating disorder or purging behaviour
- Currently uncontrolled major psychiatric disorder (e.g., schizophrenia,
bipolar disorder) or use of antipsychotic drugs.
-- Hospital admission for depression
- Learning difficulties limiting the participation in a digital health
intervention and or limiting the comprehension of trial goals or coaching
curriculum.
- 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
- Cholelithiasis or biliary dysfunction
- Creatinine > 2.0 mg·dL-1 or > 152.5 µmol·L-1
- Urinary albumin > 1 g·dL-1 or > 10 g·L-1
- Having undergone bariatric surgery
- A recent on-record estimated glomerular filtration rate of less than 30
mL/min per 1.732 m²
- 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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcomes include diabetes status as measured by indicators of blood<br /><br>glucose control and insulin production, medication use, and study feasibility,<br /><br>including digital consumer engagement and study compliance:<br /><br><br /><br>HbA1c<br /><br>Medication use </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes include biochemistry parameters (blood lipids), body<br /><br>composition, physical activity, and diet intake, as well lifestyle<br /><br>questionnaires and sleep activity.<br /><br><br /><br>Hs-CRP<br /><br>Hypertension<br /><br>Continuous glucose monitoring<br /><br>Total cholesterol<br /><br>HDL cholesterol<br /><br>LDL cholesterol<br /><br>Triglycerides<br /><br>Leukocytes<br /><br>Alcohol intake<br /><br>Dietary intake<br /><br>Physical activity<br /><br>Sleep quality<br /><br>Lifestyle questionnaire<br /><br>Sleep<br /><br>Diabetes<br /><br>Stress<br /><br>Depression<br /><br>Anxiety<br /><br>Compliance<br /><br>App literacy<br /><br>Feasibility<br /><br>Trial compliance<br /><br>Digital engagement<br /><br>OGTT<br /><br>C-peptide<br /><br>Fasting blood glucose</p><br>