Remote Glucose Monitoring in Hospital Settings
REMOTE-CGM
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.
1 other identifier
interventional
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes-mellitus-type-2
Started Jan 2023
Shorter than P25 for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2021
CompletedFirst Posted
Study publicly available on registry
March 15, 2021
CompletedStudy Start
First participant enrolled
January 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2023
CompletedFebruary 13, 2023
February 1, 2023
8 months
March 11, 2021
February 9, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time in range
% of time spent in target glucose sensor range (5.6-10.0mmol/l)
Up to 10 days
Secondary Outcomes (6)
Time above range
Up to 10 days
Time below range
Up to 10 days
Average sensor glucose
Up to 10 days
Glucose variability
Up to 10 days
Level 1 hypoglycaemia
Up to 10 days
- +1 more secondary outcomes
Other Outcomes (3)
Severe hypoglycaemia
Up to 10 days
Significant hyperglycaemia
Up to 10 days
Usability
Up to 10 days
Study Arms (2)
Real-Time CGM
EXPERIMENTALThis 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 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Manchester Royal Infirmary
Manchester, Greater Manchester, M13 9WL, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2021
First Posted
March 15, 2021
Study Start
January 9, 2023
Primary Completion
August 31, 2023
Study Completion
August 31, 2023
Last Updated
February 13, 2023
Record last verified: 2023-02