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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
What is being tested?
Real-Time CGM and Capillary blood glucose testing with masked CGM
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
  • Manchester Royal Infirmary

    Manchester, Greater Manchester, M13 9WL

    Mohammed Nazir, 0161 901 3560, Mohammed.Nazir@cmft.nhs.uk

    Hood Thabit, MD, PhD

    Recruiting

Other trials in United Kingdom

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 groups in NCT04797208
Study groupRoleWhat they receive
Real-Time CGMExperimentalThis 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 CGMActive comparatorThis 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.

  1. Time in range

    % of time spent in target glucose sensor range (5.6-10.0mmol/l)

    Measured: Up to 10 days

Secondary outcomes (6)
  1. Time above range

    % of time spent above target glucose sensor range (>10.0mmol/l)

    Measured: Up to 10 days

  2. Time below range

    % of time spent below target glucose sensor range (<5.6mmol/l)

    Measured: Up to 10 days

  3. Average sensor glucose

    Mean glucose values as recorded by CGM

    Measured: Up to 10 days

  4. Glucose variability

    Coefficient of variation of glucose levels, as recorded by CGM

    Measured: Up to 10 days

  5. Level 1 hypoglycaemia

    % of time with sensor glucose values between 3.0 - 3.9 mmol/l

    Measured: Up to 10 days

  6. 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.

  1. First posted15 Mar 2021
  2. Study start9 Jan 2023
  3. Primary completion31 Aug 2023 (estimated)
  4. Study completion31 Aug 2023 (estimated)

Resources

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)
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.

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.

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