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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04797208
Other study ID # B01121
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 9, 2023
Est. completion date August 31, 2023

Study information

Verified date February 2023
Source Manchester University NHS Foundation Trust
Contact Mohammed Nazir
Phone 0161 901 3560
Email Mohammed.Nazir@cmft.nhs.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date August 31, 2023
Est. primary completion date August 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Aged 18 years or older 2. Diagnosed with Type 2 diabetes 3. Currently receiving treatment with subcutaneous insulin alone, or in combination with oral glucose-lowering medication(s) 4. At least one CBG level > 10mmol/l 5. Have the ability to consent in English Exclusion Criteria: 1. Autoimmune type 1 diabetes 2. Known or suspected allergy against insulin 3. Current or planned pregnancy or breast feeding 4. Current in-patient in intensive care unit 5. Planned surgery during study period 6. 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. 7. Likely discharge earlier than 72 hours

Study Design


Intervention

Device:
Real-Time CGM
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 CGM
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.

Locations

Country Name City State
United Kingdom Manchester Royal Infirmary Manchester Greater Manchester

Sponsors (2)

Lead Sponsor Collaborator
Manchester University NHS Foundation Trust Manchester Academic Health Science Centre

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Severe hypoglycaemia Frequency of Level 3 (severe hypoglycaemia) events and number of hypoglycaemia treatments required Up to 10 days
Other Significant hyperglycaemia Frequency of significant hyperglycaemia (>20mmol/l) events Up to 10 days
Other Usability Feedback and experience of using CGM from participants and healthcare professionals Up to 10 days
Primary Time in range % of time spent in target glucose sensor range (5.6-10.0mmol/l) Up to 10 days
Secondary Time above range % of time spent above target glucose sensor range (>10.0mmol/l) Up to 10 days
Secondary Time below range % of time spent below target glucose sensor range (<5.6mmol/l) Up to 10 days
Secondary Average sensor glucose Mean glucose values as recorded by CGM Up to 10 days
Secondary Glucose variability Coefficient of variation of glucose levels, as recorded by CGM Up to 10 days
Secondary Level 1 hypoglycaemia % of time with sensor glucose values between 3.0 - 3.9 mmol/l Up to 10 days
Secondary Level 2 hypoglycaemia % of time with sensor glucose values <3.0 mmol/l Up to 10 days
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