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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05453344
• Other study ID #: STH22145
• Status: Completed
• Phase: N/A
• Start date: August 10, 2022
• Est. completion date: August 16, 2023

Study information

• Verified date: June 2024
• Source: Sheffield Teaching Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: August 16, 2023
• Est. primary completion date: August 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• DexCom one
Provision of DexCom One for glucose monitoring

Locations

Country	Name	City	State
United Kingdom	Sheffield Teaching Hospital NHS Foundation Trust	Sheffield	South Yorkshire

Sponsors (2)

Lead Sponsor	Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust	University of Sheffield

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c	Change in venous HbA1c at 3 and 6 months compared to baseline	6 months
Secondary	rtCGM measurements	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.	Baseline, 3 and 6 months