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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
Initial 12-week LED and behaviour education app.
Standard of care.
Lindus Health Ltd
London, London, United Kingdom
Weight loss of ≥15kg
Number of participants that achieved ≥15kg
Time frame: 6-months
HbA1C <6.5% (48mmol/mol)
Number of participants who have achieved HbA1C \<6.5% (48mmol/mol) after at least 2-months of all glucose-lowering medication.
Time frame: 6-months
Glycaemic Control
Changes in HbA1C from baseline to mid and endpoints.
Time frame: 3-months- 6-months
Weight control
Changes in weight from baseline to mid and endpoints.
Time frame: 3-months- 6-months
Systolic blood pressure (SBP)
Changes in SBP from baseline to mid and endpoints.
Time frame: 3-months- 6-months
Diastolic blood pressure (DBP)
Changes in DBP from baseline to mid and endpoints.
Time frame: 3-months- 6-months
Medication use
Medication use reported by the participant.
Time frame: Baseline, 3-months and 6-months
Weight loss ≥10kg
Number of participants that achieved ≥10kg
Time frame: 6-months
Safety of Intervention
Monitoring the number of Adverse Events (AEs), Severe Adverse Events (SAEs) and (S)AE's that constitute Major Adverse Cardiovascular Events and Major Adverse Diabetes Events
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline- 6-months
HbA1C <6.5% (48mmol/mol)
Number of participants with an HbA1C \<6.5% (48mmol/mol) after a 6-month follow up
Time frame: 12-months (6-months after completing the trial).