Digital Diabetes Remission Trial

Diabetes Mellitus, Type 2 Clinical Trial

— DIGEST  

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)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05647226
• Other study ID #: 312269
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 9, 2022
• Est. completion date: January 2024

Study information

• Verified date: December 2022
• Source: Habitual Health Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: January 2024
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Combination Product:
• Digital therapeutic and intensive lifestyle programme
Initial 12-week LED and behaviour education app.

Other:
• Standard of care
Standard of care.

Locations

Country	Name	City	State
United Kingdom	Lindus Health Ltd	London

Sponsors (2)

Lead Sponsor	Collaborator
Habitual Health Ltd	Lindus Health

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss of =15kg	Number of participants that achieved =15kg	6-months
Primary	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	Glycaemic Control	Changes in HbA1C from baseline to mid and endpoints.	3-months- 6-months
Secondary	Weight control	Changes in weight from baseline to mid and endpoints.	3-months- 6-months
Secondary	Systolic blood pressure (SBP)	Changes in SBP from baseline to mid and endpoints.	3-months- 6-months
Secondary	Diastolic blood pressure (DBP)	Changes in DBP from baseline to mid and endpoints.	3-months- 6-months
Secondary	Medication use	Medication use reported by the participant.	Baseline, 3-months and 6-months
Secondary	Weight loss =10kg	Number of participants that achieved =10kg	6-months
Secondary	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
Secondary	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).

External Links

•   Habitual Health Ltd (Sponsor)