Type 1 Diabetes
Conditions
Keywords
HCL, Type 1 Diabetes, Sensor
Brief summary
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.
Detailed description
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.
Interventions
DEVICEHybrid Closed Loop
The Hybrid Closed Loop System is an investigational device intended for closed loop control of blood glucose.
Sponsors
Medtronic Diabetes
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
subjects undergo treatment with the hybrid closed loop system under various experimental conditions
Eligibility
Sex/Gender
ALL
Age
2 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Subject is 2-75 years of age at time of screening 2. 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 : 3. 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 4. Adequate venous access as assessed by investigator or appropriate staff 5. Subject should have an established insulin carbohydrate and insulin sensitivity ratio. 6. Subject reports at the time of screening that their average fasting glucose is 60 mg/dL - 200 mg/dL 7. 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Time in Euglycemic Range - Phase 3 (Closed-loop Using the NGP Pump Platform) | 12 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subject With YSI (Yellow Spring Instrument) Dipped Below 50mg/dL - Exploratory B Phase | 1 day | 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. |
| Number of Subject Under-calibrated to Introduce a Persistent Under-reading Sensor Measurement Bias- Phase 1 | 1 day | Number of subject under-calibrated to introduce a persistent under-reading sensor measurement bias- Phase 1 |
| Percentage of Time in Euglycemic Range - Phase 2 | 3 days | Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Phase 2 |
| Percentage of Time in Euglycemic Range - Exploratory A Phase | 1 day | 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. |
| Percentage of Time in Euglycemic Range - Phase 6 | 7 days | Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Phase 6 |
| Percentage of Time in Euglycemic Range - Phase 7 | 7 days | Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Phase 7 |
| Percentage of Time in Euglycemic Range - Phase 4 | 12 days | Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Phase 4 |
Countries
United States
Participant flow
Recruitment details
A total of 8 phases: Exploratory A, Exploratory B, Phase 1, Phase 2, Phase 3, Phase 4, Phase 6 and Phase 7.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 78 |
| Total | 78 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | drop out after 3 failed attempts | 1 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Subject did not meet required BG range | 3 |
Baseline characteristics
| Characteristic | Hybrid Closed Loop |
|---|---|
| Age, Continuous | 38.5 years STANDARD_DEVIATION 16.04 |
| Region of Enrollment United States | 78 participants |
| Sex: Female, Male Female | 43 Participants |
| Sex: Female, Male Male | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 78 |
| other Total, other adverse events | 7 / 78 |
| serious Total, serious adverse events | 0 / 78 |
Outcome results
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.
Time frame: 12 days
Population: Eight type-1 diabetic subjects participated in this phase.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hybrid Closed Loop | Percentage of Time in Euglycemic Range - Phase 3 (Closed-loop Using the NGP Pump Platform) | 69.3 percentage of time | Standard Deviation 8.9 |
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
Time frame: 1 day
Population: 13 subjects with sensors under-calibrated to introduce a persistent under-reading sensor measurement bias
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hybrid Closed Loop | Number of Subject Under-calibrated to Introduce a Persistent Under-reading Sensor Measurement Bias- Phase 1 | 13 participants |
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.
Time frame: 1 day
Population: Five out of the eight subjects with YSI dipped below 50mg/dL
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hybrid Closed Loop | Number of Subject With YSI (Yellow Spring Instrument) Dipped Below 50mg/dL - Exploratory B Phase | 5 number of subjects |
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.
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hybrid Closed Loop | Percentage of Time in Euglycemic Range - Exploratory A Phase | 90.7 percentage of time | Standard Deviation 13.3 |
Secondary
Percentage of Time in Euglycemic Range - Phase 2
Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Phase 2
Time frame: 3 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hybrid Closed Loop | Percentage of Time in Euglycemic Range - Phase 2 | 65.8 percentage of time | Standard Deviation 16.2 |
Secondary
Percentage of Time in Euglycemic Range - Phase 4
Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Phase 4
Time frame: 12 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hybrid Closed Loop | Percentage of Time in Euglycemic Range - Phase 4 | 76.1 percentage of time | Standard Deviation 8.6 |
Secondary
Percentage of Time in Euglycemic Range - Phase 6
Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Phase 6
Time frame: 7 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hybrid Closed Loop | Percentage of Time in Euglycemic Range - Phase 6 | 60 percentage of time | Standard Deviation 8 |
Secondary
Percentage of Time in Euglycemic Range - Phase 7
Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Phase 7
Time frame: 7 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hybrid Closed Loop | Percentage of Time in Euglycemic Range - Phase 7 | 60 percentage of time | Standard Deviation 24.9 |