Diabetes Mellitus, Type 2REMOTE-CGMNCT04797208
Remote Glucose Monitoring in Hospital Settings
A study testing Real-Time CGM and Capillary blood glucose testing with masked CGM in people with Diabetes Mellitus, Type 2 and Hyperglycemia Stress, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Use of real-time continuous glucose monitoring (RT-CGM) systems in inpatient settings especially during the COVID-19 pandemic, may allow hospital staff to remotely monitor glucose while reducing viral exposure and preserving use of PPE. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Hyperglycemia Stress, Hypoglycemia
- What is being tested?
- Real-Time CGM and Capillary blood glucose testing with masked CGM
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Jan 2023to 31 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 or older
- Diagnosed with Type 2 diabetes
- Currently receiving treatment with subcutaneous insulin alone, or in combination with oral glucose-lowering medication(s)
- At least one CBG level > 10mmol/l
- Have the ability to consent in English
Who cannot join
- Autoimmune type 1 diabetes
- Known or suspected allergy against insulin
- Current or planned pregnancy or breast feeding
- Current in-patient in intensive care unit
- Planned surgery during study period
- Any physical or psychological disease or medication(s) likely to interfere with the conduct of the study and interpretation of the study results, as judged by the study clinician.
- Likely discharge earlier than 72 hours
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Manchester Royal Infirmary
Manchester, Greater Manchester, M13 9WL
Mohammed Nazir, 0161 901 3560, Mohammed.Nazir@cmft.nhs.uk
Hood Thabit, MD, PhD
About this study
Official title: A Pilot Randomised Study to Assess Use of Real-time Continuous Glucose Monitoring in Comparison to Conventional Capillary Blood Glucose Monitoring During COVID-19 Pandemic in Hospitalised Patients With Diabetes Mellitus.
Use of real-time continuous glucose monitoring (RT-CGM) systems in inpatient settings especially during the COVID-19 pandemic, may allow hospital staff to remotely monitor glucose while reducing viral exposure and preserving use of PPE. RT-CGM may be of benefit to inpatients with unstable glycaemia and at risk of severe hypoglycaemia, as it can automatically alert the treating clinical team of hypo and hyperglycaemia. This is of clinical relevance as up to 45% of inpatients with diabetes were found to have asymptomatic hypoglycaemia events in hospital, especially overnight. It may therefore provide a safer method of monitoring glycaemia in hospital compared to conventional bedside capillary glucose testing, by minimising the likelihood of hyper- and hypoglycaemic events and their known associated worse outcomes.
The aim of this pilot study is to to demonstrate that use of Dexcom G6 RT-CGM may provide a safer and effective method of monitoring glycemia in hospital. Data from this pilot study will be used to design and implement a larger multi-centre pivotal trial.
Read the detailed description
Hyperglycaemia in hospitalized patients is becoming a common clinical problem due to the increasing prevalence of diabetes mellitus. Hyperglycaemia in this cohort can also occur in patients with previously undiagnosed diabetes, or during acute illness in those with previously normal glucose tolerance. A growing body of evidence currently suggest that the degree of hyperglycaemia upon admission and the duration of hyperglycaemia during their illness are associated with adverse outcomes. In-patient hyperglycaemia is now widely recognised as a poor prognostic marker in terms of morbidity and mortality, increased length of stay and cost to the healthcare system. Analysis of data from nine randomised controlled trials and ten observational studies reported that treatment of hyperglycaemia in non-critically ill patients was associated with reduction in the risk of infection (relative risk, 0.41;95% confidence interval, 0.21-0.77).
The current management of inpatient hyperglycaemia in non-critical care is still far from ideal, and vary widely between different centres . The discordance between clinical evidence and practice is due to a number of factors which could potentially undermine patient care and safety. Of these, hypoglycaemia remains one the biggest barriers to managing in-patient hyperglycaemia. Hypoglycaemia is associated with increased length of stay (up to 2.3 times higher) and inpatient mortality. A recent meta-analyses reported that intensive glycaemic control on non-critical care patients is associated with a trend of increased risk of hypoglycaemia. Optimal glycaemic inpatient glucose targets still remain an intensely debated subject. Consensus from the American Association of Clinical Endocrinologists (AACE) and American Diabetes Association (ADA) recommended specified targets for hospitalised patients, of fasting or pre-meal blood glucose <7.8mmol/l and random blood glucose <10mmol/l.
Outpatient use of real-time continuous glucose monitoring (RT-CGM) is gradually increasing. Its implementation in the outpatient setting has been supported by robust scientific and clinical studies, showing benefits in glycaemic control, minimising hypoglycaemia and improving patient experience. Extending use of RT-CGM systems to inpatient settings especially during the COVID-19 pandemic may allow hospital staff to remotely monitor glucose while reducing viral exposure through frequent patient contact and preserving personal protective equipment (PPE). RT-CGM may be of benefit to inpatients with unstable glycemia (i.e. COVID-19 patients receiving dexamethasone therapy) and at risk of severe hypoglycemia, as it can automatically alert the treating clinical team of hypo- and hyperglycemia. Use of RT-CGM in hospital could therefore potentially benefits patients by improving their glycaemic control, and healthcare professionals working in busy general ward settings by providing remote real-time glucose monitoring from the patient every 10 minutes.
The main objective of this study is to assess the efficacy of RT-CGM in maintaining glucose levels within the target range (5.6 to 10.0 mmol/l) compared to conventional glucose monitoring in hospitalised insulin-treated T2D. Other objectives include evaluating safety of RT-CGM in terms of reducing the incidence of hypoglycaemia, severe hyperglycaemia, and collecting feedback of participants and healthcare professionals using RT-CGM in the general ward settings.
- Being tested
- Real-Time CGM, Capillary blood glucose testing with masked CGM
- Keywords
- Inpatient diabetes, Real-time continuous glucose monitoring, Glucose sensors, Remote monitoring
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-Time CGMDevice
Participants will be wearing a real-time continuous glucose sensor which will enable their glucose levels to be remotely monitored. High and Low glucose alerts will also be available.
Capillary blood glucose testing with masked CGMDevice
Participants will have their glucose monitored in hospital in the conventional manner using the NovaStat® glucometer or similar CE-marked glucose meter) and insulin dose adjusted by the treating clinical team as per usual hospital guidelines. A masked subcutaneous CGM will be inserted for data collection only.
| Study group | Role | What they receive |
|---|---|---|
| Real-Time CGM | Experimental | This group will have a subcutaneous RT-CGM inserted by a member of the research team. CGM's low and high glucose alerts will be activated. The treating clinical team will be able to remotely monitor glucose data and be notified of low glucose alerts through the linked handset. Hyper- and hypo-glycemia management including insulin dose adjustments by the treating clinical team, will be guided by sensor glucose levels and trends according to written guidelines during the study. Glucose level during and post-hypoglycaemia treatment will be confirmed by capillary blood glucose (CBG) measurements (using the NovaStat® glucometer or similar CE-marked glucose meter). Receives: Device: Real-Time CGM |
| Capillary blood glucose with masked CGM | Active comparator | This group will have their glucose monitored in hospital using the NovaStat® glucometer or similar CE-marked glucose meter) and insulin dose adjusted by the treating clinical team as per usual hospital guidelines. A masked subcutaneous CGM will be inserted by a member of the research team to collect glucose values (glucose values will not be displayed and no glucose alerts will be available). This will removed at the end of the study by the research team. Receives: Device: Capillary blood glucose testing with masked CGM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in range
% of time spent in target glucose sensor range (5.6-10.0mmol/l)
Measured: Up to 10 days
Secondary outcomes (6)
Time above range
% of time spent above target glucose sensor range (>10.0mmol/l)
Measured: Up to 10 days
Time below range
% of time spent below target glucose sensor range (<5.6mmol/l)
Measured: Up to 10 days
Average sensor glucose
Mean glucose values as recorded by CGM
Measured: Up to 10 days
Glucose variability
Coefficient of variation of glucose levels, as recorded by CGM
Measured: Up to 10 days
Level 1 hypoglycaemia
% of time with sensor glucose values between 3.0 - 3.9 mmol/l
Measured: Up to 10 days
Level 2 hypoglycaemia
% of time with sensor glucose values <3.0 mmol/l
Measured: Up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start9 Jan 2023
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- Manchester Academic Health Science Centre
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04797208
- Sponsor's protocol ID
- B01121
- Acronym
- REMOTE-CGM
- Status last verified
- Feb 2023
- First submitted
- 11 Mar 2021
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We may consider reasonable written request.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomised Study to Assess Use of Real-time Continuous Glucose Monitoring in Comparison to Conventional Capillary Blood Glucose Monitoring During COVID-19 Pandemic in Hospitalised Patients With Diabetes Mellitus.
- ClinicalTrials.gov ID
- NCT04797208
- Acronym / sponsor ID
- REMOTE-CGM / B01121
- Keywords
- Inpatient diabetes, Real-time continuous glucose monitoring, Glucose sensors, Remote monitoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Collaborators
- Manchester Academic Health Science Centre
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 15 Mar 2021 (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.
Use of real-time continuous glucose monitoring (RT-CGM) systems in inpatient settings especially during the COVID-19 pandemic, may allow hospital staff to remotely monitor glucose while reducing viral exposure and preserving use of PPE. RT-CGM may be of benefit to inpatients with unstable glycaemia and at risk of severe hypoglycaemia, as it can automatically alert the treating clinical team of hypo and hyperglycaemia. This is of clinical relevance as up to 45% of inpatients with diabetes were found to have asymptomatic hypoglycaemia events in hospital, especially overnight. It may therefore provide a safer method of monitoring glycaemia in hospital compared to conventional bedside capillary glucose testing, by minimising the likelihood of hyper- and hypoglycaemic events and their known associated worse outcomes.
The aim of this pilot study is to to demonstrate that use of Dexcom G6 RT-CGM may provide a safer and effective method of monitoring glycemia in hospital. Data from this pilot study will be used to design and implement a larger multi-centre pivotal trial.
Detailed description
Hyperglycaemia in hospitalized patients is becoming a common clinical problem due to the increasing prevalence of diabetes mellitus. Hyperglycaemia in this cohort can also occur in patients with previously undiagnosed diabetes, or during acute illness in those with previously normal glucose tolerance. A growing body of evidence currently suggest that the degree of hyperglycaemia upon admission and the duration of hyperglycaemia during their illness are associated with adverse outcomes. In-patient hyperglycaemia is now widely recognised as a poor prognostic marker in terms of morbidity and mortality, increased length of stay and cost to the healthcare system. Analysis of data from nine randomised controlled trials and ten observational studies reported that treatment of hyperglycaemia in non-critically ill patients was associated with reduction in the risk of infection (relative risk, 0.41;95% confidence interval, 0.21-0.77).
The current management of inpatient hyperglycaemia in non-critical care is still far from ideal, and vary widely between different centres . The discordance between clinical evidence and practice is due to a number of factors which could potentially undermine patient care and safety. Of these, hypoglycaemia remains one the biggest barriers to managing in-patient hyperglycaemia. Hypoglycaemia is associated with increased length of stay (up to 2.3 times higher) and inpatient mortality. A recent meta-analyses reported that intensive glycaemic control on non-critical care patients is associated with a trend of increased risk of hypoglycaemia. Optimal glycaemic inpatient glucose targets still remain an intensely debated subject. Consensus from the American Association of Clinical Endocrinologists (AACE) and American Diabetes Association (ADA) recommended specified targets for hospitalised patients, of fasting or pre-meal blood glucose <7.8mmol/l and random blood glucose <10mmol/l.
Outpatient use of real-time continuous glucose monitoring (RT-CGM) is gradually increasing. Its implementation in the outpatient setting has been supported by robust scientific and clinical studies, showing benefits in glycaemic control, minimising hypoglycaemia and improving patient experience. Extending use of RT-CGM systems to inpatient settings especially during the COVID-19 pandemic may allow hospital staff to remotely monitor glucose while reducing viral exposure through frequent patient contact and preserving personal protective equipment (PPE). RT-CGM may be of benefit to inpatients with unstable glycemia (i.e. COVID-19 patients receiving dexamethasone therapy) and at risk of severe hypoglycemia, as it can automatically alert the treating clinical team of hypo- and hyperglycemia. Use of RT-CGM in hospital could therefore potentially benefits patients by improving their glycaemic control, and healthcare professionals working in busy general ward settings by providing remote real-time glucose monitoring from the patient every 10 minutes.
The main objective of this study is to assess the efficacy of RT-CGM in maintaining glucose levels within the target range (5.6 to 10.0 mmol/l) compared to conventional glucose monitoring in hospitalised insulin-treated T2D. Other objectives include evaluating safety of RT-CGM in terms of reducing the incidence of hypoglycaemia, severe hyperglycaemia, and collecting feedback of participants and healthcare professionals using RT-CGM in the general ward settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real-Time CGM | Experimental | Device: Real-Time CGMThis group will have a subcutaneous RT-CGM inserted by a member of the research team. CGM's low and high glucose alerts will be activated. The treating clinical team will be able to remotely monitor glucose data and be notified of low glucose alerts through the linked handset. Hyper- and hypo-glycemia management including insulin dose adjustments by the treating clinical team, will be guided by sensor glucose levels and trends according to written guidelines during the study. Glucose level during and post-hypoglycaemia treatment will be confirmed by capillary blood glucose (CBG) measurements (using the NovaStat® glucometer or similar CE-marked glucose meter). |
| Capillary blood glucose with masked CGM | Active comparator | Device: Capillary blood glucose testing with masked CGMThis group will have their glucose monitored in hospital using the NovaStat® glucometer or similar CE-marked glucose meter) and insulin dose adjusted by the treating clinical team as per usual hospital guidelines. A masked subcutaneous CGM will be inserted by a member of the research team to collect glucose values (glucose values will not be displayed and no glucose alerts will be available). This will removed at the end of the study by the research team. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18 years or older
- Diagnosed with Type 2 diabetes
- Currently receiving treatment with subcutaneous insulin alone, or in combination with oral glucose-lowering medication(s)
- At least one CBG level > 10mmol/l
- Have the ability to consent in English
Key exclusion criteria (7 listed)
- Autoimmune type 1 diabetes
- Known or suspected allergy against insulin
- Current or planned pregnancy or breast feeding
- Current in-patient in intensive care unit
- Planned surgery during study period
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 |
|---|---|---|
| Real-Time CGMParticipants will be wearing a real-time continuous glucose sensor which will enable their glucose levels to be remotely monitored. High and Low glucose alerts will also be available. | Device | Real-Time CGM |
| Capillary blood glucose testing with masked CGMParticipants will have their glucose monitored in hospital in the conventional manner using the NovaStat® glucometer or similar CE-marked glucose meter) and insulin dose adjusted by the treating clinical team as per usual hospital guidelines. A masked subcutaneous CGM will be inserted for data collection only. | Device | Capillary blood glucose with masked CGM |
Primary outcome
Time in range
Time frame: Up to 10 days
% of time spent in target glucose sensor range (5.6-10.0mmol/l)
6 secondary outcomes
Time above range
Time frame: Up to 10 days
Time below range
Time frame: Up to 10 days
Average sensor glucose
Time frame: Up to 10 days
Glucose variability
Time frame: Up to 10 days
Level 1 hypoglycaemia
Time frame: Up to 10 days
Level 2 hypoglycaemia
Time frame: Up to 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Individual participant dataSharing planned: Undecided. We may consider reasonable written request.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real-Time CGM and Capillary blood glucose testing with masked CGM in people with Diabetes Mellitus, Type 2 and Hyperglycemia Stress, run by Manchester University 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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 13 Feb 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammed Nazir (0161 901 3560, Mohammed.Nazir@cmft.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in range (time frame: Up to 10 days). 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 13 Feb 2023.