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| ID | Type | Description | Link |
|---|---|---|---|
| 1-SRA-2014-238- | Other Grant/Funding Number | JDRF Grant Key: 1-SRA-2014-238-M-R | |
| IRB 29973 | Other Identifier | Stanford University |
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The primary objective of this study is to evaluate the safety and efficacy of the Medtronic hybrid closed-loop (HCL) system utilizing the proportional-integral-derivative algorithm with insulin feedback (PID-IFB) optimized to function in a hybrid mode with closed-loop control operating during the day and night.
Study participants will be asked to use the CGM and the study insulin pump provided for approximately 4 to 5 days prior to initiation of the HCL PID-IFB system in a hotel setting for another 4 to 5 days. All participants with diabetes and the parent/ guardian of participants < 18 years of age will be asked to stay overnight in a hotel while the HCL PID-IFB system is on and to remain close to Stanford University during the day. For participants > 18 years of age, designated remote monitors will be asked to receive alerts for low/ high glucose levels.
Enrolled participants will be asked to complete evaluations to describe their user experience/ evaluation of the system.Each participant had a companion (parent/ legal guardian of participants < 18 years of age, or the designate remote monitor for participants > 18 years of age) who will consent to monitor the participant and complete an evaluation, but will not be considered enrolled in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult Cohort | Experimental | Medtronic Hybrid Closed-Loop System will be used by adults for five days in open-loop (sensor augmented pump) and five days in closed-loop. The first 8 Adults use the Android Platform. |
|
| Adolescent Cohort | Experimental | Medtronic Hybrid Closed-Loop System will be used by adolescents for four days in open-loop (sensor augmented pump) and four days in closed-loop. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medtronic Hybrid Closed-loop System - Android Platform | Device | A continuous glucose sensor and insulin delivery system designed for continuous closed-loop control with the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm using an Android controller. |
| Measure | Description | Time Frame |
|---|---|---|
| Count of Participants With no More Than One Meter Glucose Value <50 mg/dL and no Values <40 mg/dL, no More Than Two Episodes With Meter Glucose Values Remaining >300 mg/dL for More Than 1 Hour, and no Ketonemia, Seizures, or Loss of Consciousness | Our definition of a subject successfully participating in a cohort is:
| Up to 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Glucose Values | Mean glucose values are reported as assessed by continuous glucose monitoring (CGM; subcutaneous sensor, day and night values). | Up to 10 days |
| Mean Glucose Values, Fingerstick Glucose Meter Value, Adult Cohorts |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruce A Buckingham, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University Medical Center | Stanford | California | 94305 | United States | ||
| UC Denver- Barbara Davis Center for Childhood Diabetes |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27191182 | Result | Ly TT, Weinzimer SA, Maahs DM, Sherr JL, Roy A, Grosman B, Cantwell M, Kurtz N, Carria L, Messer L, von Eyben R, Buckingham BA. Automated hybrid closed-loop control with a proportional-integral-derivative based system in adolescents and adults with type 1 diabetes: individualizing settings for optimal performance. Pediatr Diabetes. 2017 Aug;18(5):348-355. doi: 10.1111/pedi.12399. Epub 2016 May 18. | |
| 30239219 |
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There were three sites involved with the study; de-identified information was shared with the Denver and Yale sites.
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Adults were recruited in the first 2 cohorts. Following analysis of the adult cohorts, adolescents were recruited in the third cohort.
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| ID | Title | Description |
|---|---|---|
| FG000 | Adult Cohort | In part 1, participants used the system with Android interface running the algorithm; in part 2, participants used the integrated system which ran the algorithm on the pump. Medtronic Hybrid Closed-Loop System used by adults for five days in open-loop (algorithm off; sensor augmented pump) and five days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm. |
| FG001 | Adolescent Cohort | Participants only participated in part 2, which used the integrated system which ran the algorithm on the pump. Medtronic Hybrid Closed-Loop System used by adolescents for four days in open-loop (algorithm off; sensor augmented pump) and four days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Android Platform |
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| Integrated Platform |
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| ID | Title | Description |
|---|---|---|
| BG000 | Adult Cohort | In part 1, participants used the system with Android interface running the algorithm; in part 2, participants used the integrated system which ran the algorithm on the pump. Medtronic Hybrid Closed-Loop System used by adults for five days in open-loop (algorithm off; sensor augmented pump) and five days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | Count of Participants With no More Than One Meter Glucose Value <50 mg/dL and no Values <40 mg/dL, no More Than Two Episodes With Meter Glucose Values Remaining >300 mg/dL for More Than 1 Hour, and no Ketonemia, Seizures, or Loss of Consciousness | Our definition of a subject successfully participating in a cohort is:
| Posted | Count of Participants | Participants | Up to 10 days |
|
Up to 10 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 | Adult Cohort | In part 1, participants used the system with Android interface running the algorithm; in part 2, participants used the integrated system which ran the algorithm on the pump. Medtronic Hybrid Closed-Loop System used by adults for five days in open-loop (algorithm off; sensor augmented pump) and five days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycaemia | Endocrine disorders | Systematic Assessment | Hypoglycaemia defined as blood glucose <50 mg/dL |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Bruce Buckingham, MD | Stanford University | buckingham@stanford.edu |
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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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| Medtronic Hybrid Closed-loop Integrated System | Device | A fully integrated continuous glucose sensor and insulin delivery system designed for continuous closed-loop control with the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm |
|
Mean glucose values are reported as assessed by fingerstick glucose meter value.
| Up to 10 days |
| Median Glucose Values, Fingerstick Glucose Meter Value, Adolescent Cohort | Median an glucose values are reported as assessed by fingerstick glucose meter value. | Up to 10 days |
| Percentage of Time Within Glucose Range of 70-180 mg/dL | Up to 10 days |
| Percentage of Fingerstick Meter Glucose Value Tests <70 mg/dL | Up to 10 days |
| Percentage of Time With Sensor Glucose Values <70 mg/DL, Adult Cohorts | Up to 10 days |
| Percentage of Time With Sensor Glucose Values <70 mg/DL, Adolescent Cohort | Up to 10 days |
| Percentage of Fingerstick Meter Glucose Value Tests >300 mg/dL, Adult Cohort - Medtronic Android Interface | Up to 10 days |
| Percentage of Fingerstick Meter Glucose Value Tests >300 mg/dL, Adult Cohort - Integrated System Interface and Adolescent Cohort | Up to 10 days |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Yale University- Department of Pediatric Endocrinology | New Haven | Connecticut | 06520 | United States |
| Derived |
| Adams RN, Tanenbaum ML, Hanes SJ, Ambrosino JM, Ly TT, Maahs DM, Naranjo D, Walders-Abramson N, Weinzimer SA, Buckingham BA, Hood KK. Psychosocial and Human Factors During a Trial of a Hybrid Closed Loop System for Type 1 Diabetes Management. Diabetes Technol Ther. 2018 Oct;20(10):648-653. doi: 10.1089/dia.2018.0174. Epub 2018 Sep 21. |
| NOT COMPLETED |
|
|
| BG001 | Adolescent Cohort | Participants only participated in part 2, which used the integrated system which ran the algorithm on the pump. Medtronic Hybrid Closed-Loop System used by adolescents for four days in open-loop (algorithm off; sensor augmented pump) and four days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Adult Cohort - Integrated System Interface | In part 1, participants used the system with Android interface running the algorithm; in part 2, participants used the integrated system which ran the algorithm on the pump. Medtronic Hybrid Closed-Loop System used by adults for five days in open-loop (algorithm off; sensor augmented pump) and five days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm. |
| OG002 | Adolescent Cohort | Participants only participated in part 2, which used the integrated system which ran the algorithm on the pump. Medtronic Hybrid Closed-Loop System used by adolescents for four days in open-loop (algorithm off; sensor augmented pump) and four days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm. |
|
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| Secondary | Mean Glucose Values | Mean glucose values are reported as assessed by continuous glucose monitoring (CGM; subcutaneous sensor, day and night values). | Participants who completed the protocol were included in the analysis. | Posted | Mean | Standard Deviation | mg/dL | Up to 10 days |
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|
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| Secondary | Mean Glucose Values, Fingerstick Glucose Meter Value, Adult Cohorts | Mean glucose values are reported as assessed by fingerstick glucose meter value. | Data are presented for adult cohorts only. | Posted | Mean | Standard Deviation | mg/dL | Up to 10 days |
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|
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| Secondary | Median Glucose Values, Fingerstick Glucose Meter Value, Adolescent Cohort | Median an glucose values are reported as assessed by fingerstick glucose meter value. | Data are presented for the adolescent cohort only. Participants who completed the protocol were included in the analysis. | Posted | Median | Inter-Quartile Range | mg/dL | Up to 10 days |
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| Secondary | Percentage of Time Within Glucose Range of 70-180 mg/dL | Participants who completed the protocol were included in the analysis. | Posted | Mean | Standard Deviation | percentage of time in range | Up to 10 days |
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| Secondary | Percentage of Fingerstick Meter Glucose Value Tests <70 mg/dL | Participants who completed the protocol were included in the analysis. | Posted | Mean | Standard Deviation | percentage of tests | Up to 10 days |
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| Secondary | Percentage of Time With Sensor Glucose Values <70 mg/DL, Adult Cohorts | Data are presented for adult cohorts only. | Posted | Mean | Standard Deviation | percentage of time | Up to 10 days |
|
|
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| Secondary | Percentage of Time With Sensor Glucose Values <70 mg/DL, Adolescent Cohort | Data are presented for the adolescent cohort only. Participants who completed the protocol were included in the analysis. | Posted | Median | Inter-Quartile Range | percentage of time | Up to 10 days |
|
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| Secondary | Percentage of Fingerstick Meter Glucose Value Tests >300 mg/dL, Adult Cohort - Medtronic Android Interface | Data are presented for the Adult Cohort - Medtronic Android Interface only | Posted | Median | Inter-Quartile Range | percentage of readings | Up to 10 days |
|
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| Secondary | Percentage of Fingerstick Meter Glucose Value Tests >300 mg/dL, Adult Cohort - Integrated System Interface and Adolescent Cohort | Data are presented for the Adult Cohort - Integrated System Interface and the Adolescent Cohort only. Participants who completed the protocol were included in the analysis. | Posted | Mean | Standard Deviation | percentage of readings | Up to 10 days |
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| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Adolescent Cohort | Participants only participated in part 2, which used the integrated system which ran the algorithm on the pump. Medtronic Hybrid Closed-Loop System used by adolescents for four days in open-loop (algorithm off; sensor augmented pump) and four days in closed-loop (algorithm on). Algorithm was the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm. | 0 | 15 | 1 | 15 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
|
| Night (open loop) |
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| Night (closed loop) |
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| Night (open loop) |
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| Night (closed loop) |
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| Title | Measurements |
|---|---|
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| Night (closed loop) |
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