To assess the safety, acceptability and feasibility of testing Intermittent Low Energy Diet (ILED) and Continuous Low Energy Diet (CLED) programmes for 12 weeks in a real life setting with people with T1D and obesity.
The study described herein is a small randomised, open-label, single centre feasibility study of 12 patients with T1D and obesity. The aim of the study is to assess the safety, acceptability and feasibility of ILED (850kcal/day 2 days/week) and CLED (850kcal/day) over 12 weeks in a real life setting with people with T1D and obesity to help them lose weight and improve their glycaemic control. The low energy diets will involve Nestle Optifast® meal replacements as a total diet replacement (TDR). People with T1D are becoming increasingly accustomed to remote monitoring of their blood glucose by health professionals using several continuous glucose monitoring devices including the Freestyle Libre® flash glucose monitoring system. The Freestyle Libre® allows healthcare professionals to view patient blood glucose trends and patterns from the web-based platform Libreview®. The study described herein will also assess the safety and practicality of providing remote follow-up support by healthcare professionals (dietitian, nurse and psychologist) to patients with T1D and obesity during the course of implementing the low energy diets. High-frequency remote follow up has been shown to be superior to low-frequency face-to-face care in weight management interventions. Remote care reduces participants' burden to attend face-to-face appointments and may be cost-effective compared with face-to-face care whilst improving access to care. The study described herein will incorporate high-frequency remote follow up via telephone and/or the Oviva® smartphone application facilitating messaging, video calls and self-monitoring of weight and blood pressure. The Freestyle Libre® flash glucose monitoring system will facilitate remote review of blood glucose readings. Positive results from this feasibility study of two different low energy diets will inform whether one or both diets go forward into a large and longer term randomised efficacy trial following the Medical Research Council complex intervention guidance. This could provide the evidence base to inform the use of low energy diets in individuals with T1D and obesity for weight loss to improve their metabolic status and reduce the risk of cardiovascular and other physical and mental co morbidities associated with T1D.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Optifast® is provided as 53g sachet. Each sachet replaces one meal. It is available in 5 flavours: vanilla, strawberry, chocolate and coffee shakes and vegetable soup.
Manchester University NHS Foundation Trust
Manchester, Greater Manchester, United Kingdom
RECRUITINGNumber of episodes of severe hypoglycaemia i.e. capillary blood glucose < 3.0 mmol/l or requiring 3rd party assistance or any episodes of nocturnal hypoglycaemia <3.0 mmol/l.
Time frame: 14 week duration of study
Time spent in target (3.9-10mmol/l), below target (<3.9mmol/l and <3.0mmol/l) and above target (>10 mmol/l) on the Freestyle Libre® flash glucose monitoring system over 12 weeks.
Time frame: 14 week duration of study
Number of episodes of Diabetic Ketoacidosis (DKA) and blood ketone β-hydroxybutyrate levels above 1.0mmol/l.
Time frame: 14 week duration of study
Occurrence of Serious Adverse Events (SAEs) deemed potentially related to the dietary programmes.
Time frame: 14 week duration of study
Uptake to the trial i.e. percentage of those invited who are eligible and interested to take part
Time frame: 14 week duration of study
Number of participants who complete the trial measured by attendance at the 12 week appointment (for ILED and CLED)
Time frame: 14 week duration of study
Adherence to blood glucose and ketone monitoring i.e. frequency of capillary blood tests and scans
Time frame: 14 week duration of study
Percentage of low energy days completed (for ILED and CLED)
Time frame: 14 week duration of study
Dietary intake (7 day food diary). Food diaries will be analysed using Nutritics nutrition analysis software to estimate energy, fat, saturated fat, carbohydrate and protein intake
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Time frame: 14 week duration of study
Anonymous patient evaluation of the dietary programmes using an end of study questionnaire
The End of Study Questionnaire will be analysed using appropriate descriptive statistics for closed questions (scales 1 to 10 with 1 indicating "not at all" and 10 indicating "extremely" in the context of questions around satisfaction, ease of completion etc.). Key themes will be extracted without formal analysis from open questions to inform future research.
Time frame: 14 week duration of study
Percentage of multi-disciplinary team contacts with participants achieved (for ILED and CLED)
Time frame: 14 week duration of study
Uptake to and continued use of the Oviva® app i.e. percentage of participants willing to try the app and those who continue to use the different app functions over the 12 week period.
Time frame: 14 week duration of study
Number of other adverse effects potentially associated with the dietary programmes e.g. constipation, fatigue
Time frame: 14 week duration of study
Number of participants preferring food-based low energy days (for ILED and CLED)
Time frame: 14 week duration of study
Average time spent by the MDT (for ILED and CLED)
Time frame: 14 week duration of study
Percentage of contacts with Dietitian conducted face to face after baseline (for ILED and CLED)
Time frame: 14 week duration of study