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Clinical Trials/NL-OMON51256
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Ancora Health BV

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

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