Digital Diabetes Remission Trial

Not Applicable

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Other: Standard of care; Combination Product: Digital therapeutic and intensive lifestyle programme

• Registration Number: NCT05647226
• Lead Sponsor: Habitual Health Ltd

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.

Study Timeline

• Study Start: 2022-01-09
• Study First Submitted: 2022-11-30
• Status Verified: 2022-12
• Study First Submitted QC: 2022-12-09
• Last Update Submitted: 2022-12-09
• Study First Posted: 2022-12-12
• Last Update Posted: 2022-12-12
• Primary Completion: 2023-10
• Study Completion: 2024-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

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).

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of care arm	Standard of care	All participants in the control arm will receive standard care provided by the National Health Service.
Intervention arm	Digital therapeutic and intensive lifestyle programme	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Weight control	3-months- 6-months	Changes in weight from baseline to mid and endpoints.
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
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
Glycaemic Control	3-months- 6-months	Changes in HbA1C from baseline to mid and endpoints.
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

Trial Locations

Locations (1)

Lindus Health Ltd; 🇬🇧 London, United Kingdom