The DR-EAM Type 2 Diabetes Study

Sponsor

Oviva UK Ltd (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05626842

Collaborator

University of Westminster (Other)

197

Enrollment

Location

Arm

32.3

Anticipated Duration (Months)

6.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Other: Total Diet Replacement (800kcal/day)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

197 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The 'DR-EAM' Study - (Type 2) Diabetes Weight Reduction - Evaluation of Appcoaching Model

Actual Study Start Date :

Jan 20, 2021

Anticipated Primary Completion Date :

Sep 30, 2023

Anticipated Study Completion Date :

Sep 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single-arm Single-arm real-world evaluation with a matched control group from comparable GP practices	Other: Total Diet Replacement (800kcal/day) 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: TDR Low energy diet

Arm

Intervention/Treatment

Experimental: Single-arm

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

Other: Total Diet Replacement (800kcal/day)

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:

TDR

Low energy diet

Outcome Measures

Primary Outcome Measures

Primary study objective-weight [at baseline, 3, 6, 9,12 & 24 months]
Change in weight (kg) and BMI (kg/m2) continuously via BodyTrace scales
Primary study objective- HbA1c [at baseline, 6, 12 & 24 months]
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 [at baseline, 12 & 24 months]
Change in blood pressure (systolic and diastolic) via British and Irish Hypertension Society validated monitors
Secondary study objective- lipids [at baseline, 12 & 24 months]
Change in lipid markers (total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides) via venous sample
Secondary study objective- physical activity [at baseline, 3, 6, 9,12 & 24 months]
continuously via the Fitbit device
Secondary study objective- quality of life [at baseline, 6, 12 & 24 months]
change in quality of life via EQ-5D form
Secondary study objective- participant experience [at 12 months]
via NHS Friends & Family Test standardised survey

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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