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Enrolling By Invitation
NCT05647226
Digital Diabetes Remission Trial
Conditions: Diabetes Mellitus, Type 2
Sex: All
Ages: 18 Years – 75 Years
Phase: NA
Enrollment: 100
Sponsor: Habitual Health Ltd
Location: United Kingdom
Summary
This is a multicentre, open-label Randomised Controlled Trial run in the United Kingdom.
The main aims are to assess whether the Habitual Remission Programme (digital therapeutics + 12-week 800kcal/day low-energy diet, delivered remotely) is more likely to lead to weight loss and remission in adults with type 2 diabetes, when compared to standard of care.
Eligibility Criteria
Inclusion Criteria:Able and willing to give consent for the study prior to participationBe aged between 18-75 years, with type 2 Diabetes Mellitus of duration <6years.Has access to a smartphone or computerHas a Body Mass Index (BMI) of ≥28 kg/m2HbA1C between 86 mmol/mol (10%) ≥ 48mmol/mol (6.5%), within the previous 12-monthsExclusion CriteriaIs currently using InsulinWeight of change >5% in the past 3-monthsHas a history of are known to be suffering with alcohol/substance abuseHas cancer or is knowingly under investigation for cancerHas had a myocardial infarction within the previous 6-monthsHas severe or unstable heart failure e.g., New York Heart Association (NYHA) grade IVHas porphyriaHas learning difficultiesIs currently on treatment with anti-obesity drugsHas had bariatric surgeryHas been diagnosed with an eating disorder or purgingIs pregnant or less than 4-months postpartum or considering pregnancy in the next 2-yearsIs currently breastfeedingHas required hospitalisation for depression or taking antipsychotic drugHas a history of illnesses that could interfere with the interpretation of the study (e.g.
HIV, Cushing syndrome, chronic kidney disease, chronic liver disease, hyperthyroidism, hereditary fructose intolerance, depression or antipsychotic drug use within the past 2 years)Currently talking Glucagon-like peptide-1 receptor agonists (GLP-1 RAs)Has pancreatitisCurrently taking part in a Clinical Trial of an Investigative Medicinal Product (CTIMP) trial for antidiabetic medicationAbnormal diabetic foot review (QOF codes for diabetic foot at moderate risk, at high risk, at increased risk, ulcerated).
Source: ClinicalTrials.gov (NCT05647226). StuddyBuddy aggregates publicly available trial information.
