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This is a multicenter feasibility study. Up to 85 subjects will be enrolled in the study. The goal of the study is to demonstrate that the Hybrid Closed Loop (HCL) System is safe to be used in an even larger study outside of hospital.
Subjects that have met eligibility criteria will undergo treatment with the hybrid closed loop system under various experimental conditions.There is no statistically powered study hypothesis testing.
The investigational centers will be encouraged to include subjects of different ethnicities including Hispanic, Native American, and African-American.
The study is anticipated to last no more than 12 months from investigational center initiation to finalization of all data entry and monitoring procedures. Subjects are expected to participate for approximately 1- 2 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hybrid Closed Loop | Experimental | In-clinic evaluation of the HCL System under various conditions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hybrid Closed Loop | Device | The Hybrid Closed Loop System is an investigational device intended for closed loop control of blood glucose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Time in Euglycemic Range - Phase 3 (Closed-loop Using the NGP Pump Platform) | time in euglycemic range (% of Senosr Glucose (SG) 70-180 mg/dL), Phase 3 (closed-loop using the Next Generation Pump (NGP) platform). The experiment was conducted in a monitored setting which lasted for 12 days with the following stressors: missed meal bolus, exercise, missed transmission, Umax (maximum insulin limit) challenges. The study was conducted in a clinic or hotel/house environment for 12 days/11 nights with no dietary or activity restrictions. | 12 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Time in Euglycemic Range - Exploratory A Phase | Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Exploratory A phase. An overnight closed-loop experiment was performed using the Android Development Platform, software version 2.0 A system's closed-loop algorithm without implementing the upper-limit for insulin delivery. | 1 day |
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Inclusion Criteria:
Subject is 2-75 years of age at time of screening
A clinical diagnosis of type 1 diabetes as determined by either medical record or source documentation from qualified individual to make medical diagnosis
Exclusion Criteria that are Based on Demands of In-Clinic Study Procedures :
Pump therapy for greater than 6 months with use of real time CGM for any period of time (ie. one day) 3 months prior to screening
Adequate venous access as assessed by investigator or appropriate staff
Subject should have an established insulin carbohydrate and insulin sensitivity ratio.
Subject reports at the time of screening that their average fasting glucose is 60 mg/dL - 200 mg/dL
Subject reports at the time of screening that their average total daily insulin dose is 15 units - 110 units. (Insulin pump memory for this information may be used)
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| Name | Affiliation | Role |
|---|---|---|
| Scott Lee, MD | Medtronic | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AMCR Institute, Inc. 700 West El Norte Parkway, Suite 201 | Escondido | California | 92026 | United States | ||
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A total of 8 phases: Exploratory A, Exploratory B, Phase 1, Phase 2, Phase 3, Phase 4, Phase 6 and Phase 7.
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| ID | Title | Description |
|---|---|---|
| FG000 | Hybrid Closed Loop | In-clinic evaluation of the HCL System under various conditions. Hybrid Closed Loop: The Hybrid Closed Loop System is an investigational device intended for closed loop control of blood glucose. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hybrid Closed Loop | In-clinic evaluation of the HCL System under various conditions. Hybrid Closed Loop: The Hybrid Closed Loop System is an investigational device intended for closed loop control of blood glucose. |
| 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 in Euglycemic Range - Phase 3 (Closed-loop Using the NGP Pump Platform) | time in euglycemic range (% of Senosr Glucose (SG) 70-180 mg/dL), Phase 3 (closed-loop using the Next Generation Pump (NGP) platform). The experiment was conducted in a monitored setting which lasted for 12 days with the following stressors: missed meal bolus, exercise, missed transmission, Umax (maximum insulin limit) challenges. The study was conducted in a clinic or hotel/house environment for 12 days/11 nights with no dietary or activity restrictions. | Eight type-1 diabetic subjects participated in this phase. | Posted | Mean | Standard Deviation | percentage of time | 12 days |
|
30 - 60 days
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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 | Hybrid Closed Loop | In-clinic evaluation of the HCL System under various conditions. Hybrid Closed Loop: The Hybrid Closed Loop System is an investigational device intended for closed loop control of blood glucose. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Suiying Huang, Statistician | Medtronic Minimed | 818-576-3319 | suiying.huang@medtronic.com |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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subjects undergo treatment with the hybrid closed loop system under various experimental conditions
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| Number of Subject With YSI (Yellow Spring Instrument) Dipped Below 50mg/dL - Exploratory B Phase | The purpose of exploratory B study was to evaluate the efficacy and safety of the insulin upper-limit, Umax. The Umax is a patient-specific parameter which is calculated based on historical data from the pump that includes SG tracings, insulin delivery information, and the carbohydrate inputs from the user. The main objective of Umax is to prevent the user from being severely hypoglycemic (less than 50 mg/dL) by restricting the controller from over-delivery of insulin. | 1 day |
| Number of Subject Under-calibrated to Introduce a Persistent Under-reading Sensor Measurement Bias- Phase 1 | Number of subject under-calibrated to introduce a persistent under-reading sensor measurement bias- Phase 1 | 1 day |
| Percentage of Time in Euglycemic Range - Phase 2 | Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Phase 2 | 3 days |
| Percentage of Time in Euglycemic Range - Phase 4 | Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Phase 4 | 12 days |
| Percentage of Time in Euglycemic Range - Phase 6 | Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Phase 6 | 7 days |
| Percentage of Time in Euglycemic Range - Phase 7 | Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Phase 7 | 7 days |
| Barbara Davis Center, 1775 Aurora Court, A140 |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Yale University School of Medicine, 2 Church Street South, Suite 404 | New Haven | Connecticut | 06519 | United States |
| Rocky Mountain Diabetes and Osteoporosis Center | Idaho Falls | Idaho | 83404 | United States |
| University of Virginia, 617 West Main Street, 4th Floor | Charlottesville | Virginia | 22903 | United States |
| Rainier Clinical Research, 723 SW 10th Street, Suite 100 | Renton | Washington | 98057 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Percentage of Time in Euglycemic Range - Exploratory A Phase | Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Exploratory A phase. An overnight closed-loop experiment was performed using the Android Development Platform, software version 2.0 A system's closed-loop algorithm without implementing the upper-limit for insulin delivery. | Posted | Mean | Standard Deviation | percentage of time | 1 day |
|
|
|
| Secondary | Number of Subject With YSI (Yellow Spring Instrument) Dipped Below 50mg/dL - Exploratory B Phase | The purpose of exploratory B study was to evaluate the efficacy and safety of the insulin upper-limit, Umax. The Umax is a patient-specific parameter which is calculated based on historical data from the pump that includes SG tracings, insulin delivery information, and the carbohydrate inputs from the user. The main objective of Umax is to prevent the user from being severely hypoglycemic (less than 50 mg/dL) by restricting the controller from over-delivery of insulin. | Five out of the eight subjects with YSI dipped below 50mg/dL | Posted | Number | number of subjects | 1 day |
|
|
|
| Secondary | Number of Subject Under-calibrated to Introduce a Persistent Under-reading Sensor Measurement Bias- Phase 1 | Number of subject under-calibrated to introduce a persistent under-reading sensor measurement bias- Phase 1 | 13 subjects with sensors under-calibrated to introduce a persistent under-reading sensor measurement bias | Posted | Number | participants | 1 day |
|
|
|
| Secondary | Percentage of Time in Euglycemic Range - Phase 2 | Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Phase 2 | Posted | Mean | Standard Deviation | percentage of time | 3 days |
|
|
|
| Secondary | Percentage of Time in Euglycemic Range - Phase 4 | Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Phase 4 | Posted | Mean | Standard Deviation | percentage of time | 12 days |
|
|
|
| Secondary | Percentage of Time in Euglycemic Range - Phase 6 | Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Phase 6 | Posted | Mean | Standard Deviation | percentage of time | 7 days |
|
|
|
| Secondary | Percentage of Time in Euglycemic Range - Phase 7 | Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Phase 7 | Posted | Mean | Standard Deviation | percentage of time | 7 days |
|
|
|
| 0 |
| 78 |
| 0 |
| 78 |
| 7 |
| 78 |
| Left arm pain due to IV placement | General disorders | Non-systematic Assessment |
|
| Right arm pain due to IV placement | General disorders | Non-systematic Assessment |
|
| Sore Throat | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Facial petechiae of the eyes | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| costochondritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Common cold | Infections and infestations | Non-systematic Assessment |
|
| Severe hyperglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Sunburn | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |