Sheffield Teaching Hospital NHS Foundation Trust
Sheffield, South Yorkshire, S10 2JF, United Kingdom
NCT Number: NCT05453344
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Sheffield, South Yorkshire, S10 2JF, United Kingdom
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Provision of DexCom One for glucose monitoring
Time frame: 6 months
Change in venous HbA1c at 3 and 6 months compared to baseline
Time frame: Baseline, 3 and 6 months
Time glucose measurements are in range 3.9-10mmol/l, time above range 10-13.9, time significantly above range >14, time below range 3.0-3.8, and time significantly below range <3.0 mmol/L.
Sheffield Teaching Hospitals NHS Foundation Trust
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT00038727
Body Weight, CVD
Rockville, Maryland, United States
View Trial DetailsNCT06029517
Arterial Occlusive Diseases, Arteriosclerosis
Buffalo, New York, United States
View Trial DetailsNCT01934660
Cardiovascular Disease, Cardiovascular Diseases
Bethesda, Maryland, United States
View Trial DetailsNCT07728162
Diabetes Mellitus, Disease Attributes
Bolu, Turkey (Türkiye)
View Trial Details