The DR-EAM Type 2 Diabetes Study

NCT05626842 | Unknown DMC

• 2 other identifiers: DR-EAM study OvivaIRAS ID: 269780
• Study Type: interventional
• Target: 197
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

Type 2 Diabetes; Low calorie diet; Total diet replacement; behaviour change

Outcome Measures

Primary Outcomes (2)

• Primary study objective-weight

  Change in weight (kg) and BMI (kg/m2) continuously via BodyTrace scales

  at baseline, 3, 6, 9,12 & 24 months

• Primary study objective- HbA1c

  Change in HbA1c- Diabetes remission defined as 2 HbA1c readings \< 48mmol/mol without diabetes medications at least 6 months apart

  at baseline, 6, 12 & 24 months

Secondary Outcomes (5)

• Secondary study objective- blood pressure

  at baseline, 12 & 24 months

• Secondary study objective- lipids

  at baseline, 12 & 24 months

• Secondary study objective- physical activity

  at baseline, 3, 6, 9,12 & 24 months

• Secondary study objective- quality of life

  at baseline, 6, 12 & 24 months

• Secondary study objective- participant experience

  at 12 months

Study Arms (1)

Single-arm

EXPERIMENTAL

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

Other: Total Diet Replacement (800kcal/day)

Interventions

Total Diet Replacement (800kcal/day) OTHER

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.

Also known as: TDR, Low energy diet

Single-arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oviva UK Ltd: lead
• University of Westminster: collaborator

Study Sites (1)

Oviva UK ltd

London, SE1 9RS, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Lucy Jones

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: November 25, 2022
• Study Start: January 20, 2021
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: November 25, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)