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

NCT06119204 | Terminated DMC

• 1 other identifier: SAFE-LCD study (IRAS:321277)
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Treated With Insulin; Diet Habit

Outcome Measures

Primary Outcomes (1)

• Weight loss

  absolute: kg weight loss

  at 12 months

Secondary Outcomes (12)

• The number of participants reducing or ceasing insulin

  at month 3, 6, 12 and 24

• The number of participants reducing or ceasing other diabetes medications

  at month 3, 6, 12 and 24

• The number of participants reducing or ceasing cholesterol medications

  at month 3, 6, 12 and 24

• The number of participants reducing or ceasing blood pressure medications

  at month 3, 6, 12 and 24

• Hba1c (mmol/l) changes

  at month 3, 6, 12 and 24

Study Arms (2)

Intervention (Oviva ODR-I programme)

EXPERIMENTAL

The 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.

Other: Oviva programme

Control (NHS 12 weeks programme)

ACTIVE COMPARATOR

The control group will follow usual care, which will be the NHS 12-week digital weight-loss programme

Other: Usual care

Interventions

Oviva programme OTHER

Total diet replacement for insulin-treated patients

Intervention (Oviva ODR-I programme)

Usual care OTHER

NHS 12 week weight loss programme

Control (NHS 12 weeks programme)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oviva UK Ltd: lead
• Hull University Teaching Hospitals NHS Trust: collaborator
• University College, London: collaborator

Study Sites (1)

Hull University Teaching Hospital NHS Trust

Hull, HU3 2JZ, United Kingdom

Location

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Study Officials

• Professor Thozhukat Sathyapalan

  Hull University Teaching Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the intervention, participants will not be blinded, thus they will be aware of the group allocation. However, the statistician will be blinded to participant allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a single centre, parallel-group, randomised controlled trial,

Study Record Dates

• First Submitted: October 11, 2023
• First Posted: November 7, 2023
• Study Start: January 26, 2024
• Primary Completion: September 8, 2024
• Study Completion: September 9, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

GB (1)