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| Name | Class |
|---|---|
| DexCom, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Real-time continuous glucose monitoring | Active Comparator | 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. |
|
| Self-monitoring of blood glucose | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Real-time continuous glucose monitoring | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hood Thabit, MD | Manchester University NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Manchester Diabetes Centre, Manchester University NHS Foundation Trust | Manchester | M13 9WL | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32723843 | Derived | Thabit H, Prabhu JN, Mubita W, Fullwood C, Azmi S, Urwin A, Doughty I, Leelarathna L. Use of Factory-Calibrated Real-time Continuous Glucose Monitoring Improves Time in Target and HbA1c in a Multiethnic Cohort of Adolescents and Young Adults With Type 1 Diabetes: The MILLENNIALS Study. Diabetes Care. 2020 Oct;43(10):2537-2543. doi: 10.2337/dc20-0736. Epub 2020 Jul 28. |
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Anonymous participant data such as primary and secondary outcome data will be made available to researchers working directly on the study only.
Data will be available within 1 year at the end of study
Only individuals granted access will be able to view confidential anonymised data from the study.
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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.
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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.
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|
| Self-monitoring of blood glucose | Device | 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. |
|
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 |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D015190 | Blood Glucose Self-Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D000085263 | Self-Testing |
| D012648 | Self Care |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
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