Exploring the Use of Digital Therapeutics Alongside a Remote Intensive Lifestyle Programme on Inducing Weight Loss and Diabetes Remission in Patients With Type 2 Diabetes Versus Standard of Care (DIGEST)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- Habitual Health Ltd
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Weight loss of ≥15kg
- Status
- Completed
- Last Updated
- 7 months ago
Overview
Brief 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.
Detailed Description
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 by Lindus Health. Research Nurses at Lindus Health will complete screening and informed consent procedures.
Investigators
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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Weight loss of ≥15kg
Time Frame: 6-months
Number of participants that achieved ≥15kg
HbA1C <6.5% (48mmol/mol)
Time Frame: 6-months
Number of participants who have achieved HbA1C \<6.5% (48mmol/mol) after at least 2-months of all glucose-lowering medication.
Secondary Outcomes
- Weight control(3-months- 6-months)
- HbA1C <6.5% (48mmol/mol)(12-months (6-months after completing the trial).)
- Systolic blood pressure (SBP)(3-months- 6-months)
- Diastolic blood pressure (DBP)(3-months- 6-months)
- Medication use(Baseline, 3-months and 6-months)
- Weight loss ≥10kg(6-months)
- Glycaemic Control(3-months- 6-months)
- Safety of Intervention(Baseline- 6-months)