DEXCOM One Study
Research type
Research Study
Full title
DEXCOM One: Continuous glucose monitoring in the real world, utility of sustained high alerts
IRAS ID
313705
Contact name
Jackie Elliott
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 1 months, 29 days
Research summary
Summary of Research:
The purpose of this study is to gather feedback on a new continuous glucose monitor (CGM), called DEXCOM One. Unlike some other CGMs which allow a low (hypoglycaemic) and a high (hyperglycaemic) glucose alarm to be set, the DEXCOM One sensor has the unique feature of the ‘Sustained Hyperglycaemic Alert’, where the alarm is only activated if the glucose is above a certain threshold for a pre-specified amount of time.International consensus guidance states that people with diabetes should aim for 70% time in the range 3.9-10 mmol/L. After meals there is usually a rise in blood glucose, so it is not unexpected for the glucose to go above 10 mmol/L for a short time even if the insulin dose already given before a meal is correct. Therefore, people with a high glucose alarm set at 10 mmol/L on their GCM may unnecessarily inject extra insulin and risk a low blood glucose. However, DEXCOM One’s Sustained Hyperglycaemic Alert would only notify patients if their blood sugar was high for a prolonged period, and so may reflect a time when it would be genuinely advantageous to inject more insulin.
The aim of this single-centre, non-randomised, observational study is to gather experience from a range of users to assess the utility of this unique attribute, and the optimal settings. We aim to recruit 80-100 patients, and each participant's involvement is in 2 phases; for the first 3 months DEXCOM One sensors will be used, and for months 4-6 there will be the option of continuing to use the DEXCOM One sensors with the addition of a FitBit to track physical activity.
Summary of Results:
What is already known?
Previous studies, including randomized clinical trials, report improved glycaemic outcomes for people with diabetes usingthat use Dexcom G-series continuous glucose monitoring (CGM) systems.
· What has this study found?
This real-world study showed that a socioeconomically-diverse cohort of adults with suboptimally-controlled diabetes using the feature-simplified Dexcom ONE CGM system experienced significant improvements in HbA1c, CGM-derived metrics, and participant-reported outcomes.
· What are the implications of this study?
These findings suggest that use of Dexcom ONE may benefit a broader population of people with diabetes than those currently identified as candidates for CGM use by NICE guidelines.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
22/YH/0117
Date of REC Opinion
23 Jun 2022
REC opinion
Further Information Favourable Opinion