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Completed

NCT Number: NCT05453344

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sheffield Teaching Hospital NHS Foundation Trust

Sheffield, South Yorkshire, S10 2JF, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DexCom one

Device

Provision of DexCom One for glucose monitoring

Primary outcomes

  1. Change in HbA1c

    Time frame: 6 months

    Change in venous HbA1c at 3 and 6 months compared to baseline

Secondary outcomes

  1. rtCGM measurements

    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.

Sponsors and collaborators

Lead sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Other

Collaborators

  • University of Sheffield

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 12, 2022
Registry last updated
Jun 4, 2024

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.

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