Comparison of Real-tiMe ContInuous gLucosE moNitoriNg With Self-monitorIng of Blood Glucose in Young AduLts With Type 1 diabeteS

Study Overview
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Brief Summary
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The main objective of this study is to determine whether real-time continuous glucose monitoring (CGM) for 8 weeks is more efficacious compared to self-monitoring of blood glucose (SMBG) in young adults with type 1 diabetes.

Detailed Description
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This is an open-label, multi-centre, randomised, crossover design study, involving a 2-week run-in period with blinded CGM, followed by two 8 weeks study periods during which subjects will monitor daily glucose levels either with real-time CGM or SMBG in random order. Subjects will wear a blinded CGM for a 3-week period during the Control phase. A total of up to 40 subjects (aiming for 30 completed subjects) aged 16 to 24 years with T1D will be recruited through diabetes clinics and other established methods in participating centres. Subjects who drop out of the study within the first 2 weeks of the first intervention period will be replaced. Subjects will receive appropriate training in the use of real-time CGM. Subjects will have regular contact with the study team during the study. The primary outcome is time spent in target range between 3.9 and 10.0 mmol/L as recorded by CGM. Secondary outcomes are the HbA1c, time spent with glucose levels above and below target, as recorded by CGM, and other CGM-based metrics. Measures of subject's responses in terms of daily diabetes management, diabetes distress and diabetes technology use and acceptance will also be evaluated in this study.

Official Title
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An Open-label, Single-centre, Randomised, Cross-over Design Feasibility Study to Assess the Efficacy of Real-time Continuous Glucose Monitoring in Comparison With Self-monitoring of Blood Glucose in Young Adults and Adolescents With Type 1 Diabetes

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Device: Real-time continuous glucose monitoring
* Device: Self-monitoring of blood glucose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 16 - 24 years old (inclusive) Type 1 diabetes, as defined by WHO for at least 1 year or is confirmed C-peptide negative HbA1c 7.5 - 14.0% based on analysis from local laboratory or equivalent within 1 months of enrolment Treated with insulin pump or MDI Has a Smart phone compatible with Dexcom G5 or similar Willingness to wear study devices Willing to follow study specific instructions Literate in English Exclusion Criteria: Non-type 1 diabetes mellitus including those secondary to chronic disease Any other physical or psychological disease likely to interfere with the normal conduct of the study Untreated celiac disease or hypothyroidism Current or planned users of real-time or flash (Libre) glucose monitoring sensors Current treatment with drugs known to interfere with glucose metabolism, e.g. systemic corticosteroids, Metformin, SGLT2 inhibitors, GLP-1 agonists, non-selective beta-blockers and MAO inhibitors etc. Regular use of acetaminophen Medically documented allergy towards the adhesive (glue) of plasters or unable to tolerate tape adhesive in the area of sensor placement Serious skin diseases (e.g. psoriasis vulgaris, bacterial skin diseases) located at places of the body, which could potentially be used for localisation of the glucose sensor) Lack of reliable telephone facility for contact Known or suspected allergy against insulin Severe visual impairment Severe hearing impairment Subject not proficient in English

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 297 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This is an open-label, multi-centre, randomised, crossover design study, involving a 2-week run-in period with blinded CGM, followed by two 8 weeks study periods during which subjects will monitor daily glucose levels either with real-time CGM or SMBG in random order.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Real-time continuous glucose monitoring<br>Subjects will be reviewed and a blood sample will be taken for the measurement of HbA1c. Training on the use of DEXCOM G5 or similar will be provided by the research team. Competency on the use of the system will be evaluated. Participants will be advised to use real-time CGM continuously for the next 8 weeks. At the end of the first intervention, a blood sample for the measurement of HbA1c will be taken. Validated questionnaires evaluating diabetes-related distress, management and user acceptance will be completed. | Device: Real-time continuous glucose monitoring<br>* Subjects randomised to Real-time continuous glucose monitoring will be given a Dexcom G5 or similar, training on its use, and HbA1c measurements taken at the start and end of the study. They will also be given validated questionnaires to complete.<br>|
| Placebo Comparator: Self-monitoring of blood glucose<br>Subjects will be reviewed and a blood sample will be taken for the measurement of HbA1c. During the Control Period, masked CGM will be applied for one week, during Week 1, 4 and 8. At the end of this, a blood sample for the measurement of HbA1c will be taken. Validated questionnaires evaluating diabetes-related distress, management and user acceptance will be completed. | Device: Self-monitoring of blood glucose<br>* Subjects randomised to self monitoring of blood glucose will be given a masked CGM which will be applied for one week, during Week 1, 4 and 8. HbA1c measurements will be taken at the start and end of the study. They will also be given validated questionnaires to complete.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensor Glucose readings within target range | Time spent in the target range of 3.9 to 10mmol/l based on sensor glucose levels, throughout the duration of the study periods based on continuous glucose monitoring (CGM). | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensor Glucose readings below target range | Time spent with glucose levels below 3.9 mmol/L based on sensor glucose levels, throughout the duration of the study periods based on continuous glucose monitoring (CGM). | 8 weeks | 
| Sensor Glucose readings above target range | Time spent with glucose levels above 10.0 mmol/L based on sensor glucose levels, throughout the duration of the study periods based on continuous glucose monitoring (CGM). | 8 weeks | 
| HbA1c at 8 weeks | HbA1c at 8 weeks (midway point) | 8 weeks | 
| Average variation of glucose levels | Average variation of glucose levels | 8 weeks | 
| Standard deviation variation of glucose levels | Standard deviation variation of glucose levels | 8 weeks | 
| Coefficient variation of glucose levels | Coefficient variation of glucose levels | 8 weeks | 
| The time with sensor glucose levels < 3.5 mmol/l , 3.0 and <2.8 mmol/l | The time with sensor glucose levels < 3.5 mmol/l , 3.0 and <2.8 mmol/l | 8 weeks | 
| The time with sensor glucose levels in the significant hyperglycaemia (glucose levels > 16.7 mmol/l) | The time with glucose levels in the significant hyperglycaemia (glucose levels > 16.7 mmol/l) | 8 weeks | 
| AUC of glucose below 3.5mmol/l | AUC (Area under the Curve) of glucose below 3.5mmol/l | 8 weeks | 
| Total daily insulin dose | Total, basal and bolus insulin dose | 8 weeks |