The DR-EAM Type 2 Diabetes Study
The 'DR-EAM' Study - (Type 2) Diabetes Weight Reduction - Evaluation of Appcoaching Model
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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London, United Kingdom, SE1 9RS
- Oviva UK ltd
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Single-arm
Single-arm real-world evaluation with a matched control group from comparable GP practices
|
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Primary study objective-weight
Time Frame: at baseline, 3, 6, 9,12 & 24 months
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Change in weight (kg) and BMI (kg/m2) continuously via BodyTrace scales
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at baseline, 3, 6, 9,12 & 24 months
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Primary study objective- HbA1c
Time Frame: at baseline, 6, 12 & 24 months
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Change in HbA1c- Diabetes remission defined as 2 HbA1c readings < 48mmol/mol without diabetes medications at least 6 months apart
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at baseline, 6, 12 & 24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Secondary study objective- blood pressure
Time Frame: at baseline, 12 & 24 months
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Change in blood pressure (systolic and diastolic) via British and Irish Hypertension Society validated monitors
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at baseline, 12 & 24 months
|
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Secondary study objective- lipids
Time Frame: at baseline, 12 & 24 months
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Change in lipid markers (total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides) via venous sample
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at baseline, 12 & 24 months
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Secondary study objective- physical activity
Time Frame: at baseline, 3, 6, 9,12 & 24 months
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continuously via the Fitbit device
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at baseline, 3, 6, 9,12 & 24 months
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Secondary study objective- quality of life
Time Frame: at baseline, 6, 12 & 24 months
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change in quality of life via EQ-5D form
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at baseline, 6, 12 & 24 months
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Secondary study objective- participant experience
Time Frame: at 12 months
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via NHS Friends & Family Test standardised survey
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at 12 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Lucy Jones
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DR-EAM study Oviva
- IRAS ID: 269780 (Other Identifier: Heath Research Authority (HRA))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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