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

Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05453344
Collaborator
University of Sheffield (Other)
100
Enrollment
23
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    DEXCOM ONE: Continuous Glucose Monitoring in the Real World, Utility of Sustained High Alerts
    Anticipated Study Start Date :
    Aug 1, 2022
    Anticipated Primary Completion Date :
    Jun 30, 2024
    Anticipated Study Completion Date :
    Jun 30, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Change in HbA1c [6 months]

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

    Secondary Outcome Measures

    1. rtCGM measurements [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Sheffield Teaching Hospitals NHS Foundation Trust
    • University of Sheffield

    Investigators

    • Principal Investigator: Jackie Elliott, PhD, MbChB, University of Sheffield

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sheffield Teaching Hospitals NHS Foundation Trust
    ClinicalTrials.gov Identifier:
    NCT05453344
    Other Study ID Numbers:
    • STH22145
    First Posted:
    Jul 12, 2022
    Last Update Posted:
    Jul 19, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Sheffield Teaching Hospitals NHS Foundation Trust
    Insulin-dependent

    Study Results

    No Results Posted as of Jul 19, 2022