Ignite Creation Date:
2024-05-06 @ 7:43 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06119204
Status:
TERMINATED
Last Update Posted:
2024-03-20
First Post:
2023-10-11
Brief Title:
SAFE-LCD Trial for Insulin-treated Adults Living With Type 2 Diabetes
Sponsor:
Oviva UK Ltd
Organization:
Oviva UK Ltd
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Ovivas 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 62000 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 PractitionerGP usage
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 Ovivas 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 62000 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 PractitionerGP usage
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None