DEXCOM ONE: Continuous Glucose Monitoring in the Real World, Utility of Sustained High Alerts
NCT ID: NCT05453344
Last Updated: 2024-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
112 participants
INTERVENTIONAL
2022-08-10
2023-08-16
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intervention - DexCom one
Provision of DexCom one for glucose monitoring
DexCom one
Provision of DexCom One for glucose monitoring
Interventions
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DexCom one
Provision of DexCom One for glucose monitoring
Eligibility Criteria
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Inclusion Criteria
* 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 communicate in written and verbal English
18 Years
ALL
No
Sponsors
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University of Sheffield
OTHER
Sheffield Teaching Hospitals NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Jackie Elliott, PhD, MbChB
Role: PRINCIPAL_INVESTIGATOR
University of Sheffield
Locations
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Sheffield Teaching Hospital NHS Foundation Trust
Sheffield, South Yorkshire, United Kingdom
Countries
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Other Identifiers
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STH22145
Identifier Type: -
Identifier Source: org_study_id
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