Digital Diabetes Remission Trial

Launched by HABITUAL HEALTH LTD · Dec 9, 2022

Keywords

ClinConnect Summary

Participants will be randomly allocated to the Habitual Programme or standard care as delivered by the National Health Service (NHS). They will take a home blood test for HbA1c at baseline, 3 months and 6 months, and complete online fortnightly surveys to record their weight, waist circumference, blood pressure, side-effects and any changes in medication, for 6 months. These measurements will be taken at 6 months and 12 months after finishing the intervention for those allocated to the intervention.

Participants will be recruited from General Practitioner (GP) surgeries in England, managed...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Able and willing to give consent for the study prior to participation
• • Be aged between 18-75 years, with type 2 Diabetes Mellitus of duration \<6years.
• • Has access to a smartphone or computer
• • Has a Body Mass Index (BMI) of ≥28 kg/m2
• • HbA1C between 86 mmol/mol (10%) ≥ 48mmol/mol (6.5%), within the previous 12-months
• • Exclusion Criteria
• • Is currently using Insulin
• • Weight of change \>5% in the past 3-months
• • Has a history of are known to be suffering with alcohol/substance abuse
• • Has cancer or is knowingly under investigation for cancer
• • Has had a myocardial infarction within the previous 6-months
• • Has severe or unstable heart failure e.g., New York Heart Association (NYHA) grade IV
• • Has porphyria
• • Has learning difficulties
• • Is currently on treatment with anti-obesity drugs
• • Has had bariatric surgery
• • Has been diagnosed with an eating disorder or purging
• • Is pregnant or less than 4-months postpartum or considering pregnancy in the next 2-years
• • Is currently breastfeeding
• • Has required hospitalisation for depression or taking antipsychotic drug
• • Has 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 pancreatitis
• • Currently taking part in a Clinical Trial of an Investigative Medicinal Product (CTIMP) trial for antidiabetic medication
• • Abnormal diabetic foot review (QOF codes for diabetic foot at moderate risk, at high risk, at increased risk, ulcerated).

Trial Officials