NL-OMON51256
Not yet recruiting
Not Applicable
Digital, blended lifestyle intervention program for remission and improved management of type 2 diabetes - IBIDEM
Ancora Health BV0 sites410 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes
- Sponsor
- Ancora Health BV
- Enrollment
- 410
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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% (\<48 mmol/mol), individuals should still be receiving anti\-diabetic
- •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
- •\- Participation in diabetes therapy within the preceding three years;
- •participation in concurrent weight management or interventional research
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Not Applicable
Individualised Tuebingen Lifestyle Intervention ProgramDiabetesNutritional, Metabolic, EndocrineUnspecified diabetes mellitusISRCTN48274837niversity Hospital Tuebingen (Universität Tübingen) (Germany)1,000
Completed
Not Applicable
A Lifestyle Intervention Program in Children with Obesity (LIPCO)ObesityNutritional, Metabolic, EndocrineISRCTN44919688Health Authority, Västra Götaland (Sweden)25
Recruiting
Not Applicable
Development of lifestyle modification program using ICT for obese polycystic ovary syndrome patientsKCT0006062Gachon University30
Recruiting
Phase 4
2006 Cholesterol challenge StudyHypercholesterolaemiaBlood - Other blood disordersACTRN12606000127505CSIRO Human Nutrition150
Not yet recruiting
Not Applicable
Development of a life style modification program to prevent severe diabetes by introducing a psychological approach; Toward commercialization of a healthcare businessDiabetes, Prediabetes, ObesityJPRN-UMIN000019718Tokushima Data Service Co. Ltd.100