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This clinical study proposes to assess the impact of Libre on frequency, duration and severity of hypoglycaemia, compared with the Dexcom G5 realtime CGM and will focus on people with impaired awareness of hypoglycaemia.
Good glucose control in type 1 diabetes is associated with a reduced risk of diabetes complications and self monitoring of glucose levels is an important component of achieving and maintaining glucose control. Continuous glucose monitoring (CGM) improves overall glucose control in all age groups when used continuously, and reduces the incidence of low blood glucose (hypoglycaemia) in people with good glucose control. Hypoglycaemia is one of the commonest metabolic complications of type 1 diabetes and, if it occurs frequently, people can become less aware of it. This reduced aware of hypoglycaemia has significant risks including seizures, coma and even death, and has an impact on people's ability to drive and function.
The Abbott Libre intermittent glucose monitoring system provides up to 8 hours of retrospective continuous glucose monitoring data to users when the monitor is waved in proximity with the sensor. In contrast to realtime CGM the Libre system sensor is used for 14 days and is non-adjunctive (does not require calibration to capillary blood glucose).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Real time continuous glucose monitoring | Active Comparator | Use of Dexcom G5 continuous glucose monitoring |
|
| Flash glucose monitoring | Active Comparator | Use of Abbott FreeStyle Libre flash glucose monitoring |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexcom G5 Continuous Glucose Monitor | Device | Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values |
|
| Measure | Description | Time Frame |
|---|---|---|
| % Time Spent in Hypoglycaemia (<3.3mmol/L, 60mg/dL) | Percentage time spent in hypoglycaemia (<3.3mmol/L, 60mg/dL) change from baseline | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| % Time Spent in Hypoglycaemia (<2.8mmol/L, 50mg/dL) | Percentage time spent in hypoglycaemia (<2.8mmol/L, 50mg/dL) change from baseline | 10 weeks |
| % Time Spent in Hypoglycaemia (<3.9mmol/L, 70mg/dL) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nick Oliver, FRCP | Imperial College London | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31375042 | Derived | Avari P, Moscardo V, Jugnee N, Oliver N, Reddy M. Glycemic Variability and Hypoglycemic Excursions With Continuous Glucose Monitoring Compared to Intermittently Scanned Continuous Glucose Monitoring in Adults With Highest Risk Type 1 Diabetes. J Diabetes Sci Technol. 2020 May;14(3):567-574. doi: 10.1177/1932296819867688. Epub 2019 Aug 2. | |
| 29230878 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Real Time Continuous Glucose Monitoring | Use of Dexcom G5 continuous glucose monitoring Dexcom G5 Continuous Glucose Monitor: Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values |
| FG001 | Flash Glucose Monitoring | Use of Abbott FreeStyle Libre flash glucose monitoring Abbott Freestyle Libre: Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
1 participant in the CGM group was randomised and completed the trial but the CGM data could not be analysed due to an uploading error. All other data was analysed for this participant.
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| ID | Title | Description |
|---|---|---|
| BG000 | Real Time Continuous Glucose Monitoring | Use of Dexcom G5 continuous glucose monitoring Dexcom G5 Continuous Glucose Monitor: Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values |
| BG001 | Flash Glucose Monitoring |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | % Time Spent in Hypoglycaemia (<3.3mmol/L, 60mg/dL) | Percentage time spent in hypoglycaemia (<3.3mmol/L, 60mg/dL) change from baseline | Posted | Median | Inter-Quartile Range | percentage of time <3.3mmol/l | 10 weeks |
|
8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Real Time Continuous Glucose Monitoring | Use of Dexcom G5 continuous glucose monitoring Dexcom G5 Continuous Glucose Monitor: Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof Nick Oliver | Imperial College London | 02075942460 | nick.oliver@imperial.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 30, 2015 | Feb 22, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Abbott Freestyle Libre | Device | Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data |
|
Percentage time spent in hypoglycaemia (<3.9mmol/L, 70mg/dL) change in baseline to endpint
| 10 weeks |
| % Time Spent in Euglycaemia (3.9-7.8mmol/L, 70-140mg/dL) | Percentage time spent in euglycaemia (3.9-7.8mmol/L, 70-140mg/dL) change in baseline to endpoint | 10 weeks |
| % Time Spent in Euglycaemia (3.9-10mmol/L, 70-180mg/dL) | Percentage time spent in euglycaemia (3.9-10mmol/L, 70-180mg/dL) change in baseline to endpoint | 10 weeks |
| % Time Spent in Hyperglycaemia (>10mmol/L, 180mg/dL) | Percentage time spent in hyperglycaemia (>10mmol/L, 180mg/dL) change in baseline to endpoint | 10 weeks |
| % Time Spent in Hyperglycaemia (>15mmol/L, 270mg/dL) | % time spent in hyperglycaemia (>15mmol/L, 270mg/dL) change in baseline to endpoint | 10 weeks |
| Hypoglycemia | Number of participants with hypoglycemic excursions | 8 weeks |
| Severe Hypoglycaemia | Number of participants with episodes of severe hypoglycaemia | 8 weeks |
| Changes in Glucose Variability Measured | Glucose Variability measured by Coefficient of variation (CV), on a decimal scale of 0-1 | 8 weeks |
| Glucose Variability Measured by MAGE | Glucose Variability measured by Mean amplitude of Glycaemic Excursions (MAGE) | 8 weeks |
| Glucose Variability Measured by CONGA | Glucose Variability measured by Continuous Overlapping Net Glycaemic Action (CONGA) | 8 weeks |
| Reddy M, Jugnee N, El Laboudi A, Spanudakis E, Anantharaja S, Oliver N. A randomized controlled pilot study of continuous glucose monitoring and flash glucose monitoring in people with Type 1 diabetes and impaired awareness of hypoglycaemia. Diabet Med. 2018 Apr;35(4):483-490. doi: 10.1111/dme.13561. Epub 2017 Dec 29. |
Use of Abbott FreeStyle Libre flash glucose monitoring Abbott Freestyle Libre: Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
|
| Secondary | % Time Spent in Hypoglycaemia (<2.8mmol/L, 50mg/dL) | Percentage time spent in hypoglycaemia (<2.8mmol/L, 50mg/dL) change from baseline | Posted | Median | 95% Confidence Interval | percentage of time <2.8mmol/l | 10 weeks |
|
|
|
|
| Secondary | % Time Spent in Hypoglycaemia (<3.9mmol/L, 70mg/dL) | Percentage time spent in hypoglycaemia (<3.9mmol/L, 70mg/dL) change in baseline to endpint | Posted | Median | 95% Confidence Interval | percentage of time <3.9mmol/l | 10 weeks |
|
|
|
|
| Secondary | % Time Spent in Euglycaemia (3.9-7.8mmol/L, 70-140mg/dL) | Percentage time spent in euglycaemia (3.9-7.8mmol/L, 70-140mg/dL) change in baseline to endpoint | Posted | Median | 95% Confidence Interval | percentage of time >3.9<7.8 mmol/l | 10 weeks |
|
|
|
|
| Secondary | % Time Spent in Euglycaemia (3.9-10mmol/L, 70-180mg/dL) | Percentage time spent in euglycaemia (3.9-10mmol/L, 70-180mg/dL) change in baseline to endpoint | Posted | Median | 95% Confidence Interval | percentage of time >3.9<10 mmol/l | 10 weeks |
|
|
|
|
| Secondary | % Time Spent in Hyperglycaemia (>10mmol/L, 180mg/dL) | Percentage time spent in hyperglycaemia (>10mmol/L, 180mg/dL) change in baseline to endpoint | Posted | Median | 95% Confidence Interval | percentage of time >10mmol/L | 10 weeks |
|
|
|
|
| Secondary | % Time Spent in Hyperglycaemia (>15mmol/L, 270mg/dL) | % time spent in hyperglycaemia (>15mmol/L, 270mg/dL) change in baseline to endpoint | Posted | Median | 95% Confidence Interval | percentage of time >15 mmol/l | 10 weeks |
|
|
|
|
| Secondary | Hypoglycemia | Number of participants with hypoglycemic excursions | Posted | Count of Participants | Participants | 8 weeks |
|
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|
|
| Secondary | Severe Hypoglycaemia | Number of participants with episodes of severe hypoglycaemia | Posted | Count of Participants | Participants | 8 weeks |
|
|
|
|
| Secondary | Changes in Glucose Variability Measured | Glucose Variability measured by Coefficient of variation (CV), on a decimal scale of 0-1 | Posted | Median | Inter-Quartile Range | percent | 8 weeks |
|
|
|
|
| Secondary | Glucose Variability Measured by MAGE | Glucose Variability measured by Mean amplitude of Glycaemic Excursions (MAGE) | Posted | Median | Inter-Quartile Range | mmol/L | 8 weeks |
|
|
|
|
| Secondary | Glucose Variability Measured by CONGA | Glucose Variability measured by Continuous Overlapping Net Glycaemic Action (CONGA) | Posted | Median | Inter-Quartile Range | mmol/l | 8 weeks |
|
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Flash Glucose Monitoring | Use of Abbott FreeStyle Libre flash glucose monitoring Abbott Freestyle Libre: Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data | 0 | 20 | 0 | 20 | 0 | 20 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |