Diabetes MellitusNCT05453344
DEXCOM ONE: Continuous Glucose Monitoring in the Real World, Utility of Sustained High Alerts
A study testing DexCom one in people with Diabetes Mellitus, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- DexCom one
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Aug 2022to 16 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unable to provide informed consent
- Unable to communicate in written and verbal English
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Teaching Hospital NHS Foundation Trust
Sheffield, South Yorkshire, S10 2JF
About this study
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.
- Conditions
- Diabetes Mellitus
- Being tested
- DexCom one
- Keywords
- Insulin-dependent
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexCom oneDevice
Provision of DexCom One for glucose monitoring
| Study group | Role | What they receive |
|---|---|---|
| Intervention - DexCom one | Other | Provision of DexCom one for glucose monitoring Receives: Device: DexCom one |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
Change in venous HbA1c at 3 and 6 months compared to baseline
Measured: 6 months
Secondary outcomes (1)
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.
Measured: Baseline, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start10 Aug 2022
- Primary completion16 Aug 2023
- Study completion16 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sheffield
- Responsible party
- Sponsor
- Investigators
- Jackie Elliott, PhD, MbChB, Principal investigator, University of Sheffield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05453344
- Sponsor's protocol ID
- STH22145
- Status last verified
- Jun 2024
- First submitted
- 30 Jun 2022
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DEXCOM ONE: Continuous Glucose Monitoring in the Real World, Utility of Sustained High Alerts
- ClinicalTrials.gov ID
- NCT05453344
- Acronym / sponsor ID
- STH22145
- Conditions
- Diabetes Mellitus
- Keywords
- Insulin-dependent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Sheffield
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- 16 Aug 2023 (actual)
- Study completion
- 16 Aug 2023 (actual)
- First posted
- 12 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention - DexCom one | Other | Device: DexCom oneProvision of DexCom one for glucose monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Unable to provide informed consent
- Unable to communicate in written and verbal English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexCom oneProvision of DexCom One for glucose monitoring | Device | Intervention - DexCom one |
Primary outcome
Change in HbA1c
Time frame: 6 months
Change in venous HbA1c at 3 and 6 months compared to baseline
1 secondary outcome
rtCGM measurements
Time frame: Baseline, 3 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jackie Elliott, PhD, MbChB principal investigator
University of Sheffield
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DexCom one in people with Diabetes Mellitus, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.