Clinical Trials Logo

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.


Clinical 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04797208
Study type Interventional
Source Manchester University NHS Foundation Trust
Contact Mohammed Nazir
Phone 0161 901 3560
Email Mohammed.Nazir@cmft.nhs.uk
Status Recruiting
Phase N/A
Start date January 9, 2023
Completion date August 31, 2023

See also
  Status Clinical Trial Phase
Active, not recruiting NCT05666479 - CGM Monitoring in T2DM Patients Undergoing Orthopaedic Replacement Surgery
Completed NCT05647083 - The Effect of Massage on Diabetic Parameters N/A
Active, not recruiting NCT05661799 - Persistence of Physical Activity in People With Type 2 Diabetes Over Time. N/A
Completed NCT03686722 - Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin Phase 1
Completed NCT02836704 - Comparison of Standard vs Higher Starting Dose of Insulin Glargine in Chinese Patients With Type 2 Diabetes (Glargine Starting Dose) Phase 4
Completed NCT01819129 - Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes Phase 3
Completed NCT04562714 - Impact of Flash Glucose Monitoring in People With Type 2 Diabetes Using Non-Insulin Antihyperglycemic Therapy N/A
Completed NCT02009488 - Treatment Differences Between Canagliflozin and Placebo in Insulin Secretion in Subjects With Type 2 Diabetes Mellitus (T2DM) Phase 1
Completed NCT05896319 - Hyaluronic Acid Treatment of the Post-extraction Tooth Socket Healing in Subjects With Diabetes Mellitus Type 2 N/A
Recruiting NCT05598203 - Effect of Nutrition Education Groups in the Treatment of Patients With Type 2 Diabetes N/A
Completed NCT05046873 - A Research Study Looking Into Blood Levels of Semaglutide and NNC0480-0389 When Given in the Same Injection or in Two Separate Injections in Healthy People Phase 1
Terminated NCT04090242 - Impact of App Based Diabetes Training Program in Conjunction With the BD Nano Pen Needle in People With T2 Diabetes N/A
Completed NCT04030091 - Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus Phase 4
Completed NCT03604224 - A Study to Observe Clinical Effectiveness of Canagliflozin 300 mg Containing Treatment Regimens in Indian Type 2 Diabetes Participants With BMI>25 kg/m^2, in Real World Clinical Setting
Completed NCT03620357 - Continuous Glucose Monitoring & Management In Type 2 Diabetes (T2D) N/A
Completed NCT01696266 - An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
Completed NCT03620890 - Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy Phase 4
Withdrawn NCT05473286 - A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Germany, as Part of Local Clinical Practice
Not yet recruiting NCT05029804 - Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes N/A
Completed NCT04531631 - Effects of Dorzagliatin on 1st Phase Insulin and Beta-cell Glucose Sensitivity in T2D and Monogenic Diabetes Phase 2