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Type 2 Diabetes Treated With InsulinNCT06119204

SAFE-LCD Trial, for Insulin-treated Adults Living With Type 2 Diabetes

A study testing Oviva programme in people with Type 2 Diabetes Treated With Insulin and Diet Habit, run by Oviva UK Ltd at 1 site in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

SAFE-LCD study is a randomised controlled trial aiming to develop and evaluate a safe, cost-effective, easily accessible, digital Low-Calorie Diet (LCD) programme for insulin-treated adults with Type 2 diabetes (T2D), a world-first innovation. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Oviva programme
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteUnited Kingdom
Study dates
26 Jan 2024to 9 Sep 2024
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Registered with a GP practice within the confirmed NHS site - Humber and North Yorkshire
  • Diagnosis of type 2 diabetes treated with insulin
  • Age 18-70 years inclusive
  • BMI ≥30kg/m² (adjusted to ≥27 kg/m² in ethnic minority groups)
  • Upper body weight limit of 180kg (if using BodyTrace scales)
  • Ability to speak, read and receive care in English language
Show all 10Show fewer
  • Access to the internet and a personal email address
  • Access to and ability to use a smartphone
  • Willing to test blood glucose up to 7 times a day (for up to 4 months) to ensure clinical safety.
  • Participants capable to provide written informed consent and willing to comply with the trial protocol

Who cannot join

  • C-peptide <200 pmol/L AND positive Glutamic Acid Decarboxylase(GAD) antibodies assessing for misdiagnosed Type 1 diabetes and risk of diabetic ketoacidosis.
  • Type 1 diabetes mellitus, Mitochondrial diabetes, Maturity-Onset Diabetes of the Young (MODY) diabetes or diagnostic uncertainty (e.g. dual codes on patient record) Type 2 diabetes with history of diabetic ketoacidosis (DKA) or ketosis prone
  • Clinically assessed hypoglycemia unawareness (via GOLD score (11, 12))
  • Concomitant medication use clinically deemed to affect metabolic rate and body weight
  • A major cardiovascular event within 6 months
  • Severe angina, uncontrolled arrhythmia or known prolonged QT syndrome
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  • Warfarin or Rivaroxoban therapy
  • Estimated glomerular filtration rate (eGFR) of less than 30 mL/min/1.73m²
  • A condition precipitating fluid overload (e.g. New York Heart Association class III-IV congestive heart failure)
  • Active liver disease (except non-alcoholic fatty liver disease (NAFLD)
  • Active gallstone disease or known presence of gallstones
  • Active cancer, receiving cancer treatment or received cancer treatment within past 24 months
  • Known proliferative retinopathy that has not been treated
  • Uncontrolled epilepsy
  • Uncontrolled thyroid dysfunction
  • Active or suspected peptic ulcer disease
  • Gout
  • History of bariatric surgery (previous band/balloon allowed if removed<12 months)
  • Clinically diagnosed with an active eating disorder
  • Clinically significant diagnosed/self-reported psychiatric disease that may interfere with study compliance
  • Known or suspected alcohol or recreational drug misuse
  • Milk allergy (Nualtra, TDR allergens)
  • Soya allergy (Nualtra, TDR allergens)
  • Vegan (Nualtra, animal derived Vit D)
  • Pregnancy or planning pregnancy within study period
  • Lactating
  • Currently on a weight management programme or had in last 3 months or had over 5% weight loss in previous 6 months
  • Current participation in other clinical intervention trials

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Hull University Teaching Hospital NHS Trust

    Hull, HU3 2JZ

Other trials in United Kingdom

About this study

Official title: Trial to Determine Safety And Efficacy of a Digital Low-Calorie Diet Programme (SAFE-LCD) for Insulin-treated Adults Living With Type 2 Diabetes

SAFE-LCD study is a randomised controlled trial aiming to develop and evaluate a safe, cost-effective, easily accessible, digital Low-Calorie Diet (LCD) programme for insulin-treated adults with Type 2 diabetes (T2D), a world-first innovation.

The study plans to enrol 72 participants who will be randomly allocated to either receive the intervention or will be provided with weight loss advice suitable for insulin-treated patients through accessing the NHS 12-week weight loss plan. The intervention arm will follow Oviva Diabetes Remission Insulin (ODR-I) programme which includes expert dietitian coaching, support of a Diabetes Nurse, the Oviva app (with a 12-month weight prediction chart), a Capilar Blood Glucose (CBG) meters (for enhanced safety in view of concerns re hypo- and hyper-glycaemia), and BodyTrace weight scales.

If successful, this project will provide game-changing evidence for the support of insulin-treated T2D patients and for NHS commissioning of the digital Low-Calorie programme driving patient benefits and cost-savings.

Read the detailed description

Insulin treatment in Type 2 diabetes (T2D) patients is linked to poorer quality of life and and increased risk of complications due to disease progression.

This research study will be a randomised control trial (RCT) which is the highest quality form of medical evidence. It aims to develop and evaluate a safe, efficacious, cost-effective, easily accessible, digital Low-Calorie Diet (LCD) programme for insulin-treated adults with Type 2 diabetes (T2D), a world-first innovation.

The study plans to enrol 72 participants who will be randomly allocated to either receive the intervention or will be provided with weight loss advice through accessing the NHS 12-week weight loss plan.

The intervention will involve a 12-week Total Diet Replacement (TDR) diet of approximately 850 calories per day through four TDR products daily, followed by a 6-week food reintroduction period and weight maintenance support for 8 months. Care will be delivered fully remotely by Oviva's Diabetes Specialist Dietitians and Diabetes Specialist Nurse. Treatment aims are to achieve weight loss, improve diabetes control quality of life and decrease or in some cases discontinue insulin treatment.

The evaluation of ODR-I with independent clinical and health-economic evaluations will be undertaken by University College London and Insight Health Improvement and will be published in respected academic journals.

This groundbreaking research has the potential to achieve significant reductions in insulin use and to transform the lives of tens of thousands of people living with Type 2 diabetes. It will also save the NHS millions- if it is rolled out to just 62,000 patients a year, it will save more than £229 million a year in Type 2 Diabetes management costs across medications, monitoring, and hospital and General Practitioner(GP) usage.

Being tested
Oviva programme, Usual care
Medical subject headings
Feeding Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oviva programmeOther

    Total diet replacement for insulin-treated patients

  • Usual careOther

    NHS 12 week weight loss programme

Study groups in NCT06119204
Study groupRoleWhat they receive
Intervention (Oviva ODR-I programme)ExperimentalThe intervention arm will follow Oviva ODR-I programe: a 12-week TDR of approximately 850 calories per day through four TDR products daily, supported by the digital scales, CBG meters and link to the OVIVA app.
Receives: Other: Oviva programme
Control (NHS 12 weeks programme)Active comparatorThe control group will follow usual care, which will be the NHS 12-week digital weight-loss programme
Receives: Other: Usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight loss

    absolute: kg weight loss

    Measured: at 12 months

Secondary outcomes (12)

  1. The number of participants reducing or ceasing insulin

    Measured: at month 3, 6, 12 and 24

  2. The number of participants reducing or ceasing other diabetes medications

    Measured: at month 3, 6, 12 and 24

  3. The number of participants reducing or ceasing cholesterol medications

    Measured: at month 3, 6, 12 and 24

  4. The number of participants reducing or ceasing blood pressure medications

    Measured: at month 3, 6, 12 and 24

  5. Hba1c (mmol/l) changes

    Measured: at month 3, 6, 12 and 24

  6. Diabetes remission rate

    HbA1c below 6.5% (48 mmol/mol) and cessation of all diabetes medication for at least 3 months

    Measured: at months 3, 6, 12 and 24

  7. Fasting and 2 hour postprandial/random glucose (mmol/L)

    (measured via CBG meters)

    Measured: 1 year, throughout the study

  8. Weight loss

    relative: %, incl. the proportion of people achieving >5%, >10%, >15%, and >20% body weight loss

    Measured: at 3, 6 and 24 months

  9. Cardiovascular disease risk score (QRisk)

    Low Risk: A risk score of less than 10% means that there is less than a one in ten chance of developing cardiovascular disease in the next 10 years. Moderate Risk: A risk score of 10-20% means that there is between a one to two in ten chance of developing cardiovascular disease in the next 10 years. High Risk : A risk score of 20% equates to at least a two in ten chance of developing cardiovascular disease in the next 10 years.

    Measured: at months 12 and 24

  10. Diabetes-related emotional distress (DDS17)

    The scale is used to measure emotional distress related to diabetes. It yields 4 sub-scales (Emotional burden, Regimen-related distress, Physician-related distress and Interpersonal distress). An overall distress score based on the average responses on the 1-6 scale (1"not a problem" to 6 "a very significant problem'') for all 17 items.

    A mean question score of 3 or higher (moderate distress) as a level of distress worthy of clinical attention.

    Measured: at month 6, 12 and 24

  11. Diabetes Stigma Assessment Scale Type 2 (DSAS-2)

    DSAS-2 is a valid and reliable self-report measure of diabetes-related stigma. It consists of three subscales: Treated Differently, Blame and Judgment, and Self-stigma. The score can be calculated for each subscale and in total. The higher the score the bigger the stigma.

    Measured: at months 6, 12, and 24

  12. EuroQol 5 Dimension 5 Level (EQ-5D)

    EQ5D is a self-report survey that measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Higher scores indicate more severe or frequent problems.

    Measured: at month 6, 12 and 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2023
  2. Study start26 Jan 2024
  3. Primary completion8 Sep 2024
  4. Study completion9 Sep 2024

Why it stopped: Slow recruitment

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study is a single centre, parallel-group, randomised controlled trial,
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06119204
Sponsor's protocol ID
SAFE-LCD study (IRAS:321277)
Status last verified
Oct 2024
First submitted
11 Oct 2023
Last updated
15 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Oviva programme in people with Type 2 Diabetes Treated With Insulin and Diet Habit, 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 10 inclusion and 28 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: stopped early, as of the sponsor's last update on 15 Oct 2024. 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?

The study was stopped early (reason given: Slow recruitment). 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?

Weight loss (time frame: at 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06119204.

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 15 Oct 2024.

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