Type 2 DiabetesNCT05626842
The DR-EAM Type 2 Diabetes Study
A study testing Total Diet Replacement (800kcal/day) in people with Type 2 Diabetes, run by Oviva UK Ltd at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Total Diet Replacement (800kcal/day)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 197 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Jan 2021to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The 'DR-EAM' Study - (Type 2) Diabetes Weight Reduction - Evaluation of Appcoaching Model
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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- Total Diet Replacement (800kcal/day)
- Keywords
- Type 2 Diabetes, Low calorie diet, Total diet replacement, behaviour change
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Diet Replacement (800kcal/day)Other
Also called TDR, Low energy diet
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.
| Study group | Role | What they receive |
|---|---|---|
| Single-arm | Experimental | Single-arm real-world evaluation with a matched control group from comparable GP practices Receives: Other: Total Diet Replacement (800kcal/day) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary study objective-weight
Change in weight (kg) and BMI (kg/m2) continuously via BodyTrace scales
Measured: 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
Measured: at baseline, 6, 12 & 24 months
Secondary outcomes (5)
Secondary study objective- blood pressure
Change in blood pressure (systolic and diastolic) via British and Irish Hypertension Society validated monitors
Measured: at baseline, 12 & 24 months
Secondary study objective- lipids
Change in lipid markers (total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides) via venous sample
Measured: at baseline, 12 & 24 months
Secondary study objective- physical activity
continuously via the Fitbit device
Measured: at baseline, 3, 6, 9,12 & 24 months
Secondary study objective- quality of life
change in quality of life via EQ-5D form
Measured: at baseline, 6, 12 & 24 months
Secondary study objective- participant experience
via NHS Friends \& Family Test standardised survey
Measured: at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2022
- Study start20 Jan 2021
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oviva UK Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- University of Westminster
- Responsible party
- Sponsor
- Investigators
- Lucy Jones, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05626842
- Sponsor's protocol ID
- DR-EAM study Oviva
- Other IDs
- IRAS ID: 269780
- Status last verified
- Nov 2022
- First submitted
- 2 Nov 2022
- Last updated
- 25 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The 'DR-EAM' Study - (Type 2) Diabetes Weight Reduction - Evaluation of Appcoaching Model
- ClinicalTrials.gov ID
- NCT05626842
- Acronym / sponsor ID
- DR-EAM study Oviva
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 Diabetes, Low calorie diet, Total diet replacement, behaviour change
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Oviva UK LtdUniversity, hospital or other
- Collaborators
- University of Westminster
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 25 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm | Experimental | Other: Total Diet Replacement (800kcal/day)Single-arm real-world evaluation with a matched control group from comparable GP practices |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Diet Replacement (800kcal/day)Also: TDR, Low energy dietThe 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 | Single-arm |
Primary outcome
Primary study objective-weight
Time frame: at baseline, 3, 6, 9,12 & 24 months
Change in weight (kg) and BMI (kg/m2) continuously via BodyTrace scales
Primary study objective- HbA1c
Time frame: 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
5 secondary outcomes
Secondary study objective- blood pressure
Time frame: at baseline, 12 & 24 months
Secondary study objective- lipids
Time frame: at baseline, 12 & 24 months
Secondary study objective- physical activity
Time frame: at baseline, 3, 6, 9,12 & 24 months
Secondary study objective- quality of life
Time frame: at baseline, 6, 12 & 24 months
Secondary study objective- participant experience
Time frame: at 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucy Jones study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total Diet Replacement (800kcal/day) in people with Type 2 Diabetes, run by Oviva UK Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary study objective-weight (time frame: at baseline, 3, 6, 9,12 & 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2022.