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The DR-EAM Type 2 Diabetes Study

Primary Purpose

Type 2 Diabetes

Status
Active
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Total Diet Replacement (800kcal/day)
Sponsored by
Oviva UK Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Type 2 Diabetes, Low calorie diet, Total diet replacement, behaviour change

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Minimum age of 18 years Maximum age of 65 years Male or female Minimum BMI of 27kg/m2 (adjusted to 25kg/m² in people of South Asian or Chinese origin) BMI <45kg/m2 T2DM diagnosed at any time HbA1c eligibility, most recent value, which must be within 12 months: HbA1c ≥ 43 mmol/mol if on diabetes medication HbA1c ≥ 48 mmol/mol if on diet alone HBA1c <108 mmol/mol If HbA1c 90-108 mmol/mol, the value must be within 3 months of referral On, or about to start, a second-line diabetes-related medication (metformin is first-line) Access to blood glucose monitoring equipment if on a sulphonylurea prior to referral Ability to speak, read and receive care in English Access to and willing to use an iOS or Android smart phone for the duration of the intervention Exclusion Criteria: T2DM either diet-controlled alone, or on metformin alone Current insulin use Pregnant or breastfeeding or considering pregnancy during next 6 months Significant physical comorbidities: Active cancer Myocardial infarction or stroke within previous 6 months Severe heart failure defined as equivalent to the New York Heart Association grade 3 (NYHA) Recent eGFR <30 mls/min/1.73 m2 Active live disease (except for NAFLD), or a history of hepatoma, or <6 months of onset of acute hepatitis Severe angina, cardiac arrythmia including atrial fibrillation or prolonged QT syndrome Active substance use disorder / eating disorder Porphyria Weight loss >5% body weight within last 6 months or on current weight management programme or had/awaiting bariatric surgery (unless willing to come off waiting list) Health professional assessment that the person is unable to understand or meet the demands of the treatment programme and/or monitoring requirements, which may include -Learning disabilities Taking monoamine-oxidase inhibitor medication Taking warfarin Taking varenicline (smoking cessation medication) Retinopathy diagnosis or lack of retinal screening in the last year Active/investigation for gastric or duodenal ulcers People currently participating in another clinical trial

Sites / Locations

  • Oviva UK ltd

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single-arm

Arm Description

Single-arm real-world evaluation with a matched control group from comparable GP practices

Outcomes

Primary Outcome Measures

Primary study objective-weight
Change in weight (kg) and BMI (kg/m2) continuously via BodyTrace scales
Primary study objective- HbA1c
Change in HbA1c- Diabetes remission defined as 2 HbA1c readings < 48mmol/mol without diabetes medications at least 6 months apart

Secondary Outcome Measures

Secondary study objective- blood pressure
Change in blood pressure (systolic and diastolic) via British and Irish Hypertension Society validated monitors
Secondary study objective- lipids
Change in lipid markers (total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides) via venous sample
Secondary study objective- physical activity
continuously via the Fitbit device
Secondary study objective- quality of life
change in quality of life via EQ-5D form
Secondary study objective- participant experience
via NHS Friends & Family Test standardised survey

Full Information

First Posted
November 2, 2022
Last Updated
November 15, 2022
Sponsor
Oviva UK Ltd
Collaborators
University of Westminster
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1. Study Identification

Unique Protocol Identification Number
NCT05626842
Brief Title
The DR-EAM Type 2 Diabetes Study
Official Title
The 'DR-EAM' Study - (Type 2) Diabetes Weight Reduction - Evaluation of Appcoaching Model
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 20, 2021 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oviva UK Ltd
Collaborators
University of Westminster

4. Oversight

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

5. Study Description

Brief Summary
The goal of this 12-month interventional study is to analyse the clinical outcome benefits, scalability and cost-effectiveness of a digital Low-Calorie digital Type 2 diabetes mellitus (T2DM) remission program compared to usual National Health System (NHS) care.
Detailed Description
Low-Calorie Diets (LCD) have recently gained popularity as a means of achieving an average 10kg weight loss, 10mmol/mol HbA1c reductions, 50% medication reductions, and Type 2 diabetes mellitus (T2DM) remission (defined as blood-glucose levels <48mmol/mol and off all diabetes-related medications). If these clinical outcomes could be achieved at scale in the United Kingdom, the potential savings for the National Health System (NHS) from reductions in T2DM complications and medication costs are very significant. However, face-to-face T2DM LCD programs are hard to scale due to challenges of accessibility, capacity, and cost. This single-arm real-world evaluation with a matched control group from comparable GP practices will evaluate clinical outcome benefits and NHS return on investment of a digital LCD program with integrated behavior change intervention. The 197 will be recruited from GP practices across South West London and Buckinghamshire. Participants will complete a 12-week Total Diet Replacement (TDR) which involves a low-calorie (800kcal/day), nutritionally complete diet, followed by a 4-week food-based reintroduction period; and weight loss maintenance support monthly to 12 months. If a participant gains more than 2kg in the maintenance phase, they have the option to follow a TDR for an additional 4 weeks. The intervention will be led by Diabetes Specialist Dietitians (DSD) via the Oviva app, telephone, or video calls. All participants will have access to supporting learning materials. Participants will receive intensive support in the first 16 weeks; follow-up support for a further 36 weeks, plus a further 12 months of 'Active follow-up'. Participants finish the trial at 24 months. After completion, participants continue to receive free access to the Oviva app and their connected monitoring devices.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Type 2 Diabetes, Low calorie diet, Total diet replacement, behaviour change

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
197 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single-arm
Arm Type
Experimental
Arm Description
Single-arm real-world evaluation with a matched control group from comparable GP practices
Intervention Type
Other
Intervention Name(s)
Total Diet Replacement (800kcal/day)
Other Intervention Name(s)
TDR, Low energy diet
Intervention Description
The TDR intervention involves a low-calorie, nutritionally complete diet for 12 weeks consuming four meal replacement products exclusively per day, followed by a 4-week food-based reintroduction period; and then weight loss maintenance support monthly for a further 36 weeks. If a patient gains more than 2kg in the maintenance phase, they have the option to follow a TDR for an additional 4 weeks.
Primary Outcome Measure Information:
Title
Primary study objective-weight
Description
Change in weight (kg) and BMI (kg/m2) continuously via BodyTrace scales
Time Frame
at baseline, 3, 6, 9,12 & 24 months
Title
Primary study objective- HbA1c
Description
Change in HbA1c- Diabetes remission defined as 2 HbA1c readings < 48mmol/mol without diabetes medications at least 6 months apart
Time Frame
at baseline, 6, 12 & 24 months
Secondary Outcome Measure Information:
Title
Secondary study objective- blood pressure
Description
Change in blood pressure (systolic and diastolic) via British and Irish Hypertension Society validated monitors
Time Frame
at baseline, 12 & 24 months
Title
Secondary study objective- lipids
Description
Change in lipid markers (total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides) via venous sample
Time Frame
at baseline, 12 & 24 months
Title
Secondary study objective- physical activity
Description
continuously via the Fitbit device
Time Frame
at baseline, 3, 6, 9,12 & 24 months
Title
Secondary study objective- quality of life
Description
change in quality of life via EQ-5D form
Time Frame
at baseline, 6, 12 & 24 months
Title
Secondary study objective- participant experience
Description
via NHS Friends & Family Test standardised survey
Time Frame
at 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Minimum age of 18 years Maximum age of 65 years Male or female Minimum BMI of 27kg/m2 (adjusted to 25kg/m² in people of South Asian or Chinese origin) BMI <45kg/m2 T2DM diagnosed at any time HbA1c eligibility, most recent value, which must be within 12 months: HbA1c ≥ 43 mmol/mol if on diabetes medication HbA1c ≥ 48 mmol/mol if on diet alone HBA1c <108 mmol/mol If HbA1c 90-108 mmol/mol, the value must be within 3 months of referral On, or about to start, a second-line diabetes-related medication (metformin is first-line) Access to blood glucose monitoring equipment if on a sulphonylurea prior to referral Ability to speak, read and receive care in English Access to and willing to use an iOS or Android smart phone for the duration of the intervention Exclusion Criteria: T2DM either diet-controlled alone, or on metformin alone Current insulin use Pregnant or breastfeeding or considering pregnancy during next 6 months Significant physical comorbidities: Active cancer Myocardial infarction or stroke within previous 6 months Severe heart failure defined as equivalent to the New York Heart Association grade 3 (NYHA) Recent eGFR <30 mls/min/1.73 m2 Active live disease (except for NAFLD), or a history of hepatoma, or <6 months of onset of acute hepatitis Severe angina, cardiac arrythmia including atrial fibrillation or prolonged QT syndrome Active substance use disorder / eating disorder Porphyria Weight loss >5% body weight within last 6 months or on current weight management programme or had/awaiting bariatric surgery (unless willing to come off waiting list) Health professional assessment that the person is unable to understand or meet the demands of the treatment programme and/or monitoring requirements, which may include -Learning disabilities Taking monoamine-oxidase inhibitor medication Taking warfarin Taking varenicline (smoking cessation medication) Retinopathy diagnosis or lack of retinal screening in the last year Active/investigation for gastric or duodenal ulcers People currently participating in another clinical trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucy Jones
Official's Role
Study Director
Facility Information:
Facility Name
Oviva UK ltd
City
London
ZIP/Postal Code
SE1 9RS
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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The DR-EAM Type 2 Diabetes Study

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