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| Name | Class |
|---|---|
| DexCom, Inc. | INDUSTRY |
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The purpose of this study is to see if the use of a continuous glucose monitor (CGM) by people who experience low blood sugars (hypoglycemia) after gastric surgery can help reduce the number and severity of low blood sugar episodes.
The CGM devices used in this study are approved by the Food and Drug Administration (FDA) for monitoring the glucose levels of people with diabetes. The investigators of this study are looking to see if these CGM devices are able to benefit people who have had gastric surgery and experience low blood sugar episodes, which can be asymptomatic and lead to complications, impairing safety. This study involves wearing a CGM sensor/transmitter during first a masked phase (unable to see CGM sensor glucose levels), followed by an unmasked phase (able to see and respond to sensor glucose levels and alarms). Participants are asked to regularly record fingerstick (capillary) blood sugar values and any symptoms experienced, as well as a record of treatments for symptoms and glucose levels.
Participants attend three to five study visits: 5 visits for participants who wore the Dexcom G4, and 3 visits for participants who wore the Dexcom G6. The Dexcom G4 became unavailable during the course of the study when the G6 was introduced. (The Dexcom G4 had a 7 day wear period versus a 10 day wear period for the G6. As the G6 has a longer wear period, the frequency of the study visits was able to be decreased).
This study also involves the use of a fitness tracker, which will be worn for the duration of the study and returned at the end of the study.
Participants wearing the Dexcom G4 device were able to keep the Dexcom G4 CGM receiver and transmitter (this was not possible with the Dexcom G6 system).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Masked CGM Wear (Phase 1) | Other | Each participant will wear the Dexcom CGM for two sequential phases. During the first phase, participants will not be able to read the sensor glucose levels (masked). |
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| Unmasked CGM Wear (Phase 2) | Experimental | In the second phase, participants will be able to read the sensor glucose levels (unmasked). Frequency of hypoglycemia will be compared between the two phases of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexcom CGM masked | Device | The CGM will monitor sensor glucose levels in all participants. (Initially the Dexcom G4 was worn by participants (n=13); however, when the G4 became unavailable, the G6 was worn by the subsequent participants (n=10)). The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Time Sensor Glucose <70 mg/dL in the Masked Versus the Unmasked Phase. | The primary outcome will be time spent in hypoglycemic glucose range as measured by percent time sensor glucose is <70 mg/dl, comparing the masked versus the unmasked phases. | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. |
| Percentage of Time Sensor Glucose <60mg/dL in the Masked Versus the Unmasked Phase | The primary outcome will be time spent in hypoglycemic glucose range as measured by percent time sensor glucose is <60 mg/dl, comparing the masked versus the unmasked phases. | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. |
| Percentage of Time Sensor Glucose <54 mg/dL in the Masked Versus the Unmasked Phase | The primary outcome will be time spent in hypoglycemic glucose range as measured by percent time sensor glucose is <60 mg/dl, comparing the masked versus the unmasked phases. | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. |
| Measure | Description | Time Frame |
|---|---|---|
| Median Sensor Glucose Level During Masked Versus Unmasked Phases of Wear | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. | |
| Mean Sensor Glucose Level During Masked Versus Unmasked Phases of Wear | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary Elizabeth Patti, MD | Joslin Diabetes Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joslin Diabetes Center | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26701701 | Background | Patti ME, Goldfine AB. The rollercoaster of post-bariatric hypoglycaemia. Lancet Diabetes Endocrinol. 2016 Feb;4(2):94-6. doi: 10.1016/S2213-8587(15)00460-X. Epub 2015 Dec 15. No abstract available. | |
| 37046360 | Result | Cummings C, Jiang A, Sheehan A, Ferraz-Bannitz R, Puleio A, Simonson DC, Dreyfuss JM, Patti ME. Continuous glucose monitoring in patients with post-bariatric hypoglycaemia reduces hypoglycaemia and glycaemic variability. Diabetes Obes Metab. 2023 Aug;25(8):2191-2202. doi: 10.1111/dom.15096. Epub 2023 May 3. |
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After enrollment, 1 participant was withdrawn and did not complete baseline evaluation (visit 1) due to hospitalization.
Following baseline evaluation (visit 1), 2 participants were lost to followup and did not complete the masked CGM wear period.
One additional participant was excluded due to missing data and therefore could not be included in the analyses.
Patients with post-gastric surgery hypoglycemia were recruited from the Hypoglycemia Clinic at Joslin Diabetes Center, directed by Dr. Patti. The study was explained to potential participants initially in the clinical setting or during a subsequent telephone screening session.
Recruitment took place between February of 2019 through December of 2021. The dexcom G4 was available for the first 13 participants. The remaining 10 participants wore the dexcom G6.
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| ID | Title | Description |
|---|---|---|
| FG000 | CGM Use | Each participant wore the Dexcom continuous glucose monitor (CGM) available at their time of participation. The Dexcom G4 became unavailable during the course of the study and later participants wore the Dexcom G6. During the first two weeks (Dexcom G4) or first 10 days (Dexcom G6), participants were not able to read the sensor glucose levels. In the second two weeks (Dexcom G4) or second 10 days (Dexcom G6), participants were able to read the sensor glucose levels. Frequency of hypoglycemia was compared between the two phases of the study (masked versus unmasked CGM). Dexcom CGM: The CGM monitored sensor glucose levels in all participants. During the first two weeks (Dexcom G4) or first 10 days (Dexcom G6) of the study, participants were masked to the sensor glucose levels and needed to use other methods, such as a blood sample from a finger stick, to check their blood sugar. During the second two weeks (Dexcom G4) or second10 days (Dexcom G6), participants were able to see the sensor glucose levels displayed from the CGM. Participants were instructed to use this information to treat low glucose levels before symptoms or severely low glucose levels developed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Masked CGM Wear |
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| Unmasked CGM Wear |
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25 participants completed baseline evaluation after enrollment and these are reflected in this analysis. After baseline evaluation 2 participants were lost to follow-up before CGM download, and 1 participant's CGM data was corrupted; therefore all analysis after baseline assessment are for a total of 22 participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | CGM Use | Each participant wore the Dexcom continuous glucose monitor (CGM) available at their time of participation. The Dexcom G4 became unavailable during the course of the study and later participants wore the Dexcom G6. During the first two weeks (Dexcom G4) or first 10 days (Dexcom G6), participants were not able to read the sensor glucose levels. In the second two weeks (Dexcom G4) or second 10 days (Dexcom G6), participants were able to read the sensor glucose levels. Frequency of hypoglycemia was compared between the two phases of the study (masked versus unmasked CGM). Dexcom CGM: The CGM monitored sensor glucose levels in all participants. During the first two weeks (Dexcom G4) or first 10 days (Dexcom G6) of the study, participants were masked to the sensor glucose levels and needed to use other methods, such as a blood sample from a finger stick, to check their blood sugar. During the second two weeks (Dexcom G4) or second10 days (Dexcom G6), participants were able to see the sensor glucose levels displayed from the CGM. Participants were instructed to use this information to treat low glucose levels before symptoms or severely low glucose levels developed. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percentage of Time Sensor Glucose <70 mg/dL in the Masked Versus the Unmasked Phase. | The primary outcome will be time spent in hypoglycemic glucose range as measured by percent time sensor glucose is <70 mg/dl, comparing the masked versus the unmasked phases. | Posted | Median | Standard Deviation | Percentage of time | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. |
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For participants using a Dexcom G4 sensor, adverse event data were collected over a period of 28 days. For participants using a Dexcom G4 sensor, adverse event data were collected over a period of 20 days.
Study clinicians assessed participants for adverse events at all study visits.
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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 | Masked CGM Wear (Phase 1) | During the first phase, participants will not be able to read the sensor glucose levels (masked). Dexcom CGM masked: The CGM will monitor sensor glucose levels in all participants. (Initially the Dexcom G4 was worn by participants (n=13); however, when the G4 became unavailable, the G6 was worn by the subsequent participants (n=10)). The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depressive episode | General disorders | Depression | Non-systematic Assessment | Episode of severe depression requiring inpatient psychiatric hospitalization. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycemia requiring emergency department evaluation | Metabolism and nutrition disorders | Non-systematic Assessment | Evaluated in the emergency department (transported from home) due to low glucose (50 mg/dL). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary Elizabeth Patti, MD | Joslin Diabetes Center | 6713092635 | MaryElizabeth.Patti@Joslin.Harvard.edu |
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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 | Jul 15, 2020 | Apr 13, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 15, 2020 | Apr 13, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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The proposed study is designed to assess the efficacy of unmasked personal CGM to reduce the frequency of hypoglycemia after gastric surgery. Specifically, we will analyze glycemic patterns during a phase of baseline masked CGM wear (2 weeks for the Dexcom G4 or 10 days for the Dexcom G6), in comparison to a sequential, second phase of unmasked CGM wear (2 weeks for the Dexcom G4 or 10 days for the Dexcom G6). Please note that we have chosen to have a consistent masked monitoring first, as providing unmasked data to participants first could alter their dietary or other patterns and reduce ability of the study to independently assess efficacy of the CGM intervention.
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The proposed study is designed to assess the efficacy of unmasked personal CGM to reduce the frequency of hypoglycemia after gastric surgery. Participants themselves will not be masked to study design. The only masking will be of the device sensor glucose data during the first 2 weeks (Dexcom G4) or 10 days (Dexcom G6) of the study.
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| Dexcom CGM unmasked | Device | During the second phase (2 weeks for the Dexcom G4 and 10 days for the Dexcom G6), participants are able to see the sensor glucose levels displayed from the CGM. Participants will be instructed to use this information to treat low glucose levels before symptoms or severely low glucose levels develop. The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation). |
|
| Peak Sensor Glucose Level During Masked Versus Unmasked Period of CGM Wear | expressed as median and median standard deviation | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. |
| Sensor Glucose Level Range (Highest Sensor Glucose Minus Lowest Sensor Glucose mg/dL) During Masked Versus Unmasked Period of CGM Wear | The sensor glucose level range is derived from the difference between the highest sensor glucose levels minus the lowest sensor glucose level (mg/dL). | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. |
| Nadir Sensor Glucose Level During Masked Versus Unmasked Period of CGM Wear | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. |
| Percent of Time Sensor Glucose 70-180 mg/dL During Period of CGM Wear, Masked Versus Unmasked Phase | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. |
| Percentage of Time Sensor Glucose Level >180 mg/dL During Period of CGM Wear, Masked Versus Unmasked Phase | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. |
| Percentage of Time Sensor Glucose Level >250 mg/dL During Periods of CGM Wear, Masked Versus Unmasked Phase | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. |
| Glycemic Variability as Measured by the Standard Deviation of Sensor Glucose Level Data During Periods of CGM Wear, Masked Versus Unmasked Phase | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. |
| Mean Coefficient of Variation of Sensor Glucose Data During Period of CGM Wear, Masked Versus Unmasked Phase | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. |
| Mean Amplitude of Glycemic Excursion (MAGE) of Sensor Glucose Levels During Periods of CGM Wear, Masked Versus Unmasked Phase | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. |
| 24 Hour Continuous Overall Net Glycemic Action (CONGA) for Sensor Glucose Data During Periods of CGM Wear, Masked Versus Unmasked Phase | CONGA assesses glucose variability within a predetermined time window - 24 hours in this case. Calculation of this parameter is based on the assessment of the differences between glucose values measured at regular time intervals, then on the standard deviation (SD) of these differences | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. |
| 1 Hour Continuous Overall Net Glycemic Action (CONGA) for Sensor Glucose Data During Periods of CGM Wear, Masked Versus Unmasked Phase | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. |
| 2 Hours, Continuous Overall Net Glycemic Action (CONGA) for Sensor Glucose Data During Periods of CGM Wear, Masked Versus Unmasked Phase | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. |
| 4 Hours, Continuous Overall Net Glycemic Action (CONGA) for Sensor Glucose Data During Periods of CGM Wear, Masked Versus Unmasked Phase | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. |
| Total Number of Hypoglycemic Events During the Masked Versus the Unmasked Phases of CGM Wear, as Defined by a Sensor Glucose <70 mg/dL, for at Least 15 Minutes | Hypoglycemic events are defined as having glucose <70 mg/dL for at least 15 minutes, ending when glucose > the threshold. Hypoglycemic event values were normalized by dividing the number of events by the number of days of data. | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. |
| Total Number of Hypoglycemic Events Defined by a Sensor Glucose <60 mg/dL, for at Lease 15 Minutes, During the Masked Versus Unmasked CGM Phase | Hypoglycemic events are defined as having glucose <60 mg/dL for at least 15 minutes, ending when glucose > the threshold. Hypoglycemic event values were normalized by dividing the number of events by the number of days of data. | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. |
| Total Number of Hypoglycemic Events Defined by a Sensor Glucose <54 mg/dL, for at Least 15 Minutes, During the Masked Versus Unmasked CGM Phase | Hypoglycemic events are defined as having glucose <54 mg/dL for at least 15 minutes, ending when glucose > the threshold. Hypoglycemic event values were normalized by dividing the number of events by the number of days of data. | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Hemoglobin A1c | Mean | Standard Deviation | percent |
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| Pre-operative Body Mass Index (BMI) | Mean | Standard Deviation | mg/k^2 |
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| Current BMI | Mean | Standard Deviation | mg/k^2 |
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| Years post-bariatric surgery | Mean | Standard Deviation | years |
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| Years between bariatric surgery and hypoglycemia onset | Mean | Standard Deviation | years |
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| Percentage of participants with a history of level III hypoglycemia (requiring assistance) | Number | percentage of participants |
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| Percentage of participants with a history of neuroglycopenia | Number | percentage of participants |
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| Visit 1 Edinburgh Hypoglycemia Symptom Scale (EHSS) Score | EHSS score range 18 to 126, with a higher number indicating a greater symptom severity score. | Mean | Standard Deviation | units on a scale (EHSS score) |
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| Visit 1 Dumping Symptom Rating Scale (DSRS) Score | DSRS scores range 9 to 56, with a higher score indicating a greater symptom severity score. | Mean | Standard Deviation | units on a scale (DSRS score) |
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| OG001 | Unmasked CGM Wear (Phase 2) | During the second phase, participants will be able to read the sensor glucose levels (unmasked). Participants will be instructed to use this information to treat low glucose levels before symptoms or severely low glucose levels develop. The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation). |
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| Primary | Percentage of Time Sensor Glucose <60mg/dL in the Masked Versus the Unmasked Phase | The primary outcome will be time spent in hypoglycemic glucose range as measured by percent time sensor glucose is <60 mg/dl, comparing the masked versus the unmasked phases. | Posted | Median | Standard Deviation | Percentage of time | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. |
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| Primary | Percentage of Time Sensor Glucose <54 mg/dL in the Masked Versus the Unmasked Phase | The primary outcome will be time spent in hypoglycemic glucose range as measured by percent time sensor glucose is <60 mg/dl, comparing the masked versus the unmasked phases. | Posted | Median | Standard Deviation | Percentage of time | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. |
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| Secondary | Median Sensor Glucose Level During Masked Versus Unmasked Phases of Wear | Posted | Median | Inter-Quartile Range | mg/dL | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. |
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| Secondary | Mean Sensor Glucose Level During Masked Versus Unmasked Phases of Wear | Posted | Mean | Standard Deviation | mg/dL | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. |
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| Secondary | Peak Sensor Glucose Level During Masked Versus Unmasked Period of CGM Wear | expressed as median and median standard deviation | Posted | Median | Standard Deviation | mg/dL | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. |
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| Secondary | Sensor Glucose Level Range (Highest Sensor Glucose Minus Lowest Sensor Glucose mg/dL) During Masked Versus Unmasked Period of CGM Wear | The sensor glucose level range is derived from the difference between the highest sensor glucose levels minus the lowest sensor glucose level (mg/dL). | Posted | Median | Standard Deviation | mg/dL | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. |
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| Secondary | Nadir Sensor Glucose Level During Masked Versus Unmasked Period of CGM Wear | Posted | Median | Standard Deviation | mg/dL | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. |
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| Secondary | Percent of Time Sensor Glucose 70-180 mg/dL During Period of CGM Wear, Masked Versus Unmasked Phase | Posted | Median | Standard Deviation | Percentage of time | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. |
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| Secondary | Percentage of Time Sensor Glucose Level >180 mg/dL During Period of CGM Wear, Masked Versus Unmasked Phase | Posted | Median | Standard Deviation | Percentage of time | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. |
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| Secondary | Percentage of Time Sensor Glucose Level >250 mg/dL During Periods of CGM Wear, Masked Versus Unmasked Phase | Posted | Median | Standard Deviation | Percentage of time | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. |
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| Secondary | Glycemic Variability as Measured by the Standard Deviation of Sensor Glucose Level Data During Periods of CGM Wear, Masked Versus Unmasked Phase | Posted | Median | Standard Deviation | mg/dL | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. |
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| Secondary | Mean Coefficient of Variation of Sensor Glucose Data During Period of CGM Wear, Masked Versus Unmasked Phase | Posted | Mean | Standard Deviation | Integer (of variation) | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. |
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| Secondary | Mean Amplitude of Glycemic Excursion (MAGE) of Sensor Glucose Levels During Periods of CGM Wear, Masked Versus Unmasked Phase | Posted | Mean | Standard Deviation | mg/dL | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. |
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| Secondary | 24 Hour Continuous Overall Net Glycemic Action (CONGA) for Sensor Glucose Data During Periods of CGM Wear, Masked Versus Unmasked Phase | CONGA assesses glucose variability within a predetermined time window - 24 hours in this case. Calculation of this parameter is based on the assessment of the differences between glucose values measured at regular time intervals, then on the standard deviation (SD) of these differences | Posted | Median | Standard Deviation | mg/dL | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. |
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| Secondary | 1 Hour Continuous Overall Net Glycemic Action (CONGA) for Sensor Glucose Data During Periods of CGM Wear, Masked Versus Unmasked Phase | Posted | Median | Standard Deviation | mg/dL | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. |
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| Secondary | 2 Hours, Continuous Overall Net Glycemic Action (CONGA) for Sensor Glucose Data During Periods of CGM Wear, Masked Versus Unmasked Phase | Posted | Median | Standard Deviation | mg/dL | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. |
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| Secondary | 4 Hours, Continuous Overall Net Glycemic Action (CONGA) for Sensor Glucose Data During Periods of CGM Wear, Masked Versus Unmasked Phase | Posted | Median | Standard Deviation | mg/dL | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. |
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| Secondary | Total Number of Hypoglycemic Events During the Masked Versus the Unmasked Phases of CGM Wear, as Defined by a Sensor Glucose <70 mg/dL, for at Least 15 Minutes | Hypoglycemic events are defined as having glucose <70 mg/dL for at least 15 minutes, ending when glucose > the threshold. Hypoglycemic event values were normalized by dividing the number of events by the number of days of data. | Posted | Median | Standard Deviation | Number of events per period of wear | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. |
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| Secondary | Total Number of Hypoglycemic Events Defined by a Sensor Glucose <60 mg/dL, for at Lease 15 Minutes, During the Masked Versus Unmasked CGM Phase | Hypoglycemic events are defined as having glucose <60 mg/dL for at least 15 minutes, ending when glucose > the threshold. Hypoglycemic event values were normalized by dividing the number of events by the number of days of data. | Posted | Median | Standard Deviation | Number of events per period of wear | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. |
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| Secondary | Total Number of Hypoglycemic Events Defined by a Sensor Glucose <54 mg/dL, for at Least 15 Minutes, During the Masked Versus Unmasked CGM Phase | Hypoglycemic events are defined as having glucose <54 mg/dL for at least 15 minutes, ending when glucose > the threshold. Hypoglycemic event values were normalized by dividing the number of events by the number of days of data. | Posted | Median | Standard Deviation | Number of events per period of wear | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. |
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| 0 |
| 25 |
| 1 |
| 25 |
| 2 |
| 25 |
| EG001 | Unmasked CGM Wear (Phase 2) | During the second phase, participants will be able to read the sensor glucose levels (unmasked). Participants will be instructed to use this information to treat low glucose levels before symptoms or severely low glucose levels develop. The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation). | 0 | 23 | 0 | 23 | 1 | 23 |
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| Skin irritation under Dexcom G4 sensor site | Skin and subcutaneous tissue disorders | skin irritation | Non-systematic Assessment | # At risk consists of the 13 total participants using a Dexcom G4 sensor |
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| Mild erythema under dexcom G4 sensor adhesive | Skin and subcutaneous tissue disorders | Non-systematic Assessment | # At risk consists of the 13 total participants using a Dexcom G4 sensor |
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| Discomfort at site of Dexcom G4 sensor | Skin and subcutaneous tissue disorders | Non-systematic Assessment | # At risk consists of the 13 total participants using a Dexcom G4 sensor |
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