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

NCT06119204 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2024-10-15

No results posted yet for this study

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

Interventions

OTHER

Oviva programme

Total diet replacement for insulin-treated patients

OTHER

Usual care

NHS 12 week weight loss programme

Sponsors & Collaborators

  • Hull University Teaching Hospitals NHS Trust

    collaborator OTHER_GOV

  • University College, London

    collaborator OTHER

  • Oviva UK Ltd

    lead OTHER

Principal Investigators

  • Professor Thozhukat Sathyapalan · Hull University Teaching Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-26
Primary Completion
2024-09-08
Completion
2024-09-09

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06119204 on ClinicalTrials.gov