Clinical trial NCT05647226: Digital Diabetes Remission Trial
Official title: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Habitual Health Ltd
Sponsor class: INDUSTRY
Collaborators: name: Lindus Health
First posted: 2022-12-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A multicentre, open-label, parallel design, randomised controlled trial.
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Weight loss of ≥15kg
timeFrame: 6-months
measure: HbA1C <6.5% (48mmol/mol)
timeFrame: 6-months
Secondary outcomes:
measure: Glycaemic Control
timeFrame: 3-months- 6-months
measure: Weight control
timeFrame: 3-months- 6-months
measure: Systolic blood pressure (SBP)
timeFrame: 3-months- 6-months
measure: Diastolic blood pressure (DBP)
timeFrame: 3-months- 6-months
measure: Medication use
timeFrame: Baseline, 3-months and 6-months
measure: Weight loss ≥10kg
timeFrame: 6-months
measure: Safety of Intervention
timeFrame: Baseline- 6-months
measure: HbA1C <6.5% (48mmol/mol)
timeFrame: 12-months (6-months after completing the trial).
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Lindus Health Ltd
Study officials:
affiliation: Principal Investigator
name: Carol Le Roux, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.