Digital Diabetes Remission Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Combination Product: Digital therapeutic and intensive lifestyle programme
* Other: Standard of care


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A multicentre, open-label, parallel design, randomised controlled trial.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>Intervention participants will be given an initial 12-week low energy-diet (LED) and will have continual use of an intensive behaviour education programme delivered through an app. | Combination Product: Digital therapeutic and intensive lifestyle programme<br>* Initial 12-week LED and behaviour education app.<br>|
| Other: Standard of care arm<br>All participants in the control arm will receive standard care provided by the National Health Service. | Other: Standard of care<br>* Standard of care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss of ≥15kg | Number of participants that achieved ≥15kg | 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. | 6-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycaemic Control | Changes in HbA1C from baseline to mid and endpoints. | 3-months- 6-months | 
| Weight control | Changes in weight from baseline to mid and endpoints. | 3-months- 6-months | 
| Systolic blood pressure (SBP) | Changes in SBP from baseline to mid and endpoints. | 3-months- 6-months | 
| Diastolic blood pressure (DBP) | Changes in DBP from baseline to mid and endpoints. | 3-months- 6-months | 
| Medication use | Medication use reported by the participant. | Baseline, 3-months and 6-months | 
| Weight loss ≥10kg | Number of participants that achieved ≥10kg | 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 | Baseline- 6-months | 
| HbA1C <6.5% (48mmol/mol) | Number of participants with an HbA1C <6.5% (48mmol/mol) after a 6-month follow up | 12-months (6-months after completing the trial). |