Clinical trial NCT06119204: SAFE-LCD Trial, for Insulin-treated Adults Living With Type 2 Diabetes
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Type 2 Diabetes Treated With Insulin
Diet Habit
Lead sponsor: Oviva UK Ltd
Sponsor class: OTHER
Collaborators: name: Hull University Teaching Hospitals NHS Trust
name: University College, London
First posted: 2023-11-07
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a single centre, parallel-group, randomised controlled trial,
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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
* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Weight loss
timeFrame: at 12 months
Secondary outcomes:
measure: The number of participants reducing or ceasing insulin
timeFrame: at month 3, 6, 12 and 24
measure: The number of participants reducing or ceasing other diabetes medications
timeFrame: at month 3, 6, 12 and 24
measure: The number of participants reducing or ceasing cholesterol medications
timeFrame: at month 3, 6, 12 and 24
measure: The number of participants reducing or ceasing blood pressure medications
timeFrame: at month 3, 6, 12 and 24
measure: Hba1c (mmol/l) changes
timeFrame: at month 3, 6, 12 and 24
measure: Diabetes remission rate
timeFrame: at months 3, 6, 12 and 24
measure: Fasting and 2 hour postprandial/random glucose (mmol/L)
timeFrame: 1 year, throughout the study
measure: Weight loss
timeFrame: at 3, 6 and 24 months
measure: Cardiovascular disease risk score (QRisk)
timeFrame: at months 12 and 24
measure: Diabetes-related emotional distress (DDS17)
timeFrame: at month 6, 12 and 24
measure: Diabetes Stigma Assessment Scale Type 2 (DSAS-2)
timeFrame: at months 6, 12, and 24
measure: EuroQol 5 Dimension 5 Level (EQ-5D)
timeFrame: at month 6, 12 and 24
Other outcomes:
Locations:
city: Hull
country: United Kingdom
facility: Hull University Teaching Hospital NHS Trust
Study officials:
affiliation: Hull University Teaching Hospital
name: Professor Thozhukat Sathyapalan
role: PRINCIPAL_INVESTIGATOR
References: