DIGEST: Digital Diabetes Remission Trial
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention arm 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
Initial 12-week LED and behaviour education app.
|
| Other: Standard of care arm All participants in the control arm will receive standard care provided by the National Health Service. |
Other: Standard of care
Standard of care.
|
Outcome Measures
Primary Outcome Measures
- Weight loss of ≥15kg [6-months]
Number of participants that achieved ≥15kg
- HbA1C <6.5% (48mmol/mol) [6-months]
Number of participants who have achieved HbA1C <6.5% (48mmol/mol) after at least 2-months of all glucose-lowering medication.
Secondary Outcome Measures
- Glycaemic Control [3-months- 6-months]
Changes in HbA1C from baseline to mid and endpoints.
- Weight control [3-months- 6-months]
Changes in weight from baseline to mid and endpoints.
- Systolic blood pressure (SBP) [3-months- 6-months]
Changes in SBP from baseline to mid and endpoints.
- Diastolic blood pressure (DBP) [3-months- 6-months]
Changes in DBP from baseline to mid and endpoints.
- Medication use [Baseline, 3-months and 6-months]
Medication use reported by the participant.
- Weight loss ≥10kg [6-months]
Number of participants that achieved ≥10kg
- Safety of Intervention [Baseline- 6-months]
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
- HbA1C <6.5% (48mmol/mol) [12-months (6-months after completing the trial).]
Number of participants with an HbA1C <6.5% (48mmol/mol) after a 6-month follow up
Eligibility Criteria
Criteria
Inclusion Criteria:
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Able and willing to give consent for the study prior to participation
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Be aged between 18-75 years, with type 2 Diabetes Mellitus of duration <6years.
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Has access to a smartphone or computer
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Has a Body Mass Index (BMI) of ≥28 kg/m2
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HbA1C between 86 mmol/mol (10%) ≥ 48mmol/mol (6.5%), within the previous 12-months
Exclusion Criteria
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Is currently using Insulin
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Weight of change >5% in the past 3-months
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Has a history of are known to be suffering with alcohol/substance abuse
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Has cancer or is knowingly under investigation for cancer
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Has had a myocardial infarction within the previous 6-months
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Has severe or unstable heart failure e.g., New York Heart Association (NYHA) grade IV
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Has porphyria
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Has learning difficulties
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Is currently on treatment with anti-obesity drugs
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Has had bariatric surgery
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Has been diagnosed with an eating disorder or purging
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Is pregnant or less than 4-months postpartum or considering pregnancy in the next 2-years
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Is currently breastfeeding
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Has required hospitalisation for depression or taking antipsychotic drug
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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)
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Currently talking Glucagon-like peptide-1 receptor agonists (GLP-1 RAs)
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Has pancreatitis
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Currently taking part in a Clinical Trial of an Investigative Medicinal Product (CTIMP) trial for antidiabetic medication
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Abnormal diabetic foot review (QOF codes for diabetic foot at moderate risk, at high risk, at increased risk, ulcerated).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Lindus Health Ltd | London | United Kingdom | SE1 3ER |
Sponsors and Collaborators
- Habitual Health Ltd
- Lindus Health
Investigators
- Principal Investigator: Carol Le Roux, Professor, Principal Investigator
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Lean ME, Leslie WS, Barnes AC, Brosnahan N, Thom G, McCombie L, Peters C, Zhyzhneuskaya S, Al-Mrabeh A, Hollingsworth KG, Rodrigues AM, Rehackova L, Adamson AJ, Sniehotta FF, Mathers JC, Ross HM, McIlvenna Y, Stefanetti R, Trenell M, Welsh P, Kean S, Ford I, McConnachie A, Sattar N, Taylor R. Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial. Lancet. 2018 Feb 10;391(10120):541-551. doi: 10.1016/S0140-6736(17)33102-1. Epub 2017 Dec 5.
- Lean MEJ, Leslie WS, Barnes AC, Brosnahan N, Thom G, McCombie L, Peters C, Zhyzhneuskaya S, Al-Mrabeh A, Hollingsworth KG, Rodrigues AM, Rehackova L, Adamson AJ, Sniehotta FF, Mathers JC, Ross HM, McIlvenna Y, Welsh P, Kean S, Ford I, McConnachie A, Messow CM, Sattar N, Taylor R. Durability of a primary care-led weight-management intervention for remission of type 2 diabetes: 2-year results of the DiRECT open-label, cluster-randomised trial. Lancet Diabetes Endocrinol. 2019 May;7(5):344-355. doi: 10.1016/S2213-8587(19)30068-3. Epub 2019 Mar 6.
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