Skip to content

DEXCOM ONE: Continuous Glucose Monitoring in the Real World, Utility of Sustained High Alerts

DEXCOM ONE: Continuous Glucose Monitoring in the Real World, Utility of Sustained High Alerts

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05453344
Enrollment
112
Registered
2022-07-12
Start date
2022-08-10
Completion date
2023-08-16
Last updated
2024-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Keywords

Insulin-dependent

Brief summary

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.

Interventions

DEVICEDexCom one

Provision of DexCom One for glucose monitoring

Sponsors

University of Sheffield
CollaboratorOTHER
Sheffield Teaching Hospitals NHS Foundation Trust
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Aged 18+ years * A patient registered in the diabetes service at Sheffield Teaching Hospitals NHS Foundation Trust * HbA1c within the last 3 months of \>70 mmol/mol

Exclusion criteria

* Unable to provide informed consent * Unable to communicate in written and verbal English

Design outcomes

Primary

MeasureTime frameDescription
Change in HbA1c6 monthsChange in venous HbA1c at 3 and 6 months compared to baseline

Secondary

MeasureTime frameDescription
rtCGM measurementsBaseline, 3 and 6 monthsTime 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.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026