Diabetes
Conditions
Interventions
Patients will partake in a 24-week intervention followed by a two-year
follow-up period. The intervention will consist of diabetic phenotyping
(diabetyping), and a personalised app-based lifestyle i
Sponsors
Ancora Health BV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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% (
Exclusion criteria
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) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcomes include diabetes status as measured by indicators of blood glucose control and insulin production, medication use, and study feasibility, including digital consumer engagement and study compliance: HbA1c Medication use | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include biochemistry parameters (blood lipids), body composition, physical activity, and diet intake, as well lifestyle questionnaires and sleep activity. Hs-CRP Hypertension Continuous glucose monitoring Total cholesterol HDL cholesterol LDL cholesterol Triglycerides Leukocytes Alcohol intake Dietary intake Physical activity Sleep quality Lifestyle questionnaire Sleep Diabetes Stress Depression Anxiety Compliance App literacy Feasibility Trial compliance Digital engagement OGTT C-peptide Fasting blood glucose | — |
Countries
Netherlands
Outcome results
None listed