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Digital Diabetes Remission Trial (DIGEST)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Digital therapeutic and intensive lifestyle programme
Standard of care
Sponsored by
Habitual Health Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Lindus Health Ltd

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention arm

Standard of care arm

Arm Description

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.

All participants in the control arm will receive standard care provided by the National Health Service.

Outcomes

Primary Outcome Measures

Weight loss of ≥15kg
Number of participants that achieved ≥15kg
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.

Secondary Outcome Measures

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

Full Information

First Posted
November 30, 2022
Last Updated
December 9, 2022
Sponsor
Habitual Health Ltd
Collaborators
Lindus Health
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1. Study Identification

Unique Protocol Identification Number
NCT05647226
Brief Title
Digital Diabetes Remission Trial
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 9, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Habitual Health Ltd
Collaborators
Lindus Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A multicentre, open-label, parallel design, randomised controlled trial.
Masking
Outcomes Assessor
Masking Description
Due to the nature of the lifestyle programme, participants, clinicians and data collectors will not be able to be masked, however allocation will be concealed from the statistician in charge of performing the analysis.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of care arm
Arm Type
Other
Arm Description
All participants in the control arm will receive standard care provided by the National Health Service.
Intervention Type
Combination Product
Intervention Name(s)
Digital therapeutic and intensive lifestyle programme
Intervention Description
Initial 12-week LED and behaviour education app.
Intervention Type
Other
Intervention Name(s)
Standard of care
Intervention Description
Standard of care.
Primary Outcome Measure Information:
Title
Weight loss of ≥15kg
Description
Number of participants that achieved ≥15kg
Time Frame
6-months
Title
HbA1C <6.5% (48mmol/mol)
Description
Number of participants who have achieved HbA1C <6.5% (48mmol/mol) after at least 2-months of all glucose-lowering medication.
Time Frame
6-months
Secondary Outcome Measure Information:
Title
Glycaemic Control
Description
Changes in HbA1C from baseline to mid and endpoints.
Time Frame
3-months- 6-months
Title
Weight control
Description
Changes in weight from baseline to mid and endpoints.
Time Frame
3-months- 6-months
Title
Systolic blood pressure (SBP)
Description
Changes in SBP from baseline to mid and endpoints.
Time Frame
3-months- 6-months
Title
Diastolic blood pressure (DBP)
Description
Changes in DBP from baseline to mid and endpoints.
Time Frame
3-months- 6-months
Title
Medication use
Description
Medication use reported by the participant.
Time Frame
Baseline, 3-months and 6-months
Title
Weight loss ≥10kg
Description
Number of participants that achieved ≥10kg
Time Frame
6-months
Title
Safety of Intervention
Description
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
Time Frame
Baseline- 6-months
Title
HbA1C <6.5% (48mmol/mol)
Description
Number of participants with an HbA1C <6.5% (48mmol/mol) after a 6-month follow up
Time Frame
12-months (6-months after completing the trial).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol Le Roux, Professor
Organizational Affiliation
Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lindus Health Ltd
City
London
ZIP/Postal Code
SE1 3ER
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will be entered into a validated Electronic Data Capture (EDC) platform. Direct access to the EDC platform will be granted to authorised representatives from the Sponsor, Lindus Health and the regulatory authorities to allow trial-related monitoring, audits and inspections.
Citations:
PubMed Identifier
29221645
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.
Results Reference
background
PubMed Identifier
30852132
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.
Results Reference
background
Links:
URL
https://www.tryhabitual.com/
Description
Habitual Health Ltd (Sponsor)

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Digital Diabetes Remission Trial

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