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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
21
Total diet replacement for insulin-treated patients
NHS 12 week weight loss programme
Hull University Teaching Hospital NHS Trust
Hull, United Kingdom
Weight loss
absolute: kg weight loss
Time frame: at 12 months
The number of participants reducing or ceasing insulin
Time frame: at month 3, 6, 12 and 24
The number of participants reducing or ceasing other diabetes medications
Time frame: at month 3, 6, 12 and 24
The number of participants reducing or ceasing cholesterol medications
Time frame: at month 3, 6, 12 and 24
The number of participants reducing or ceasing blood pressure medications
Time frame: at month 3, 6, 12 and 24
Hba1c (mmol/l) changes
Time frame: at month 3, 6, 12 and 24
Diabetes remission rate
HbA1c below 6.5% (48 mmol/mol) and cessation of all diabetes medication for at least 3 months
Time frame: at months 3, 6, 12 and 24
Fasting and 2 hour postprandial/random glucose (mmol/L)
(measured via CBG meters)
Time frame: 1 year, throughout the study
Weight loss
relative: %, incl. the proportion of people achieving \>5%, \>10%, \>15%, and \>20% body weight loss
Time frame: at 3, 6 and 24 months
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.
Time frame: at months 12 and 24
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.
Time frame: at month 6, 12 and 24
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.
Time frame: at months 6, 12, and 24
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.
Time frame: at month 6, 12 and 24
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