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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
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.
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
Stanford University Medical Center
Stanford, California, United States
UC Denver- Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States
Yale University- Department of Pediatric Endocrinology
New Haven, Connecticut, United States
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: 1. No more than one meter glucose value \<50 mg/dL and no values \<40 mg/dL 2. No more than two episodes with meter glucose values remaining \>300 mg/dL for more than 1 hour that are unrelated to an infusion set failure 3. No ketonemia \>1.0 mmol/L, while the system is functional unless related to an intercurrent illness or infusion set failure 4. No seizures or loss of consciousness while system is on and functional
Time frame: Up to 10 days
Mean Glucose Values
Mean glucose values are reported as assessed by continuous glucose monitoring (CGM; subcutaneous sensor, day and night values).
Time frame: Up to 10 days
Mean Glucose Values, Fingerstick Glucose Meter Value, Adult Cohorts
Mean glucose values are reported as assessed by fingerstick glucose meter value.
Time frame: 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.
Time frame: Up to 10 days
Percentage of Time Within Glucose Range of 70-180 mg/dL
Time frame: Up to 10 days
Percentage of Fingerstick Meter Glucose Value Tests <70 mg/dL
Time frame: Up to 10 days
Percentage of Time With Sensor Glucose Values <70 mg/DL, Adult Cohorts
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Up to 10 days
Percentage of Time With Sensor Glucose Values <70 mg/DL, Adolescent Cohort
Time frame: Up to 10 days
Percentage of Fingerstick Meter Glucose Value Tests >300 mg/dL, Adult Cohort - Medtronic Android Interface
Time frame: Up to 10 days
Percentage of Fingerstick Meter Glucose Value Tests >300 mg/dL, Adult Cohort - Integrated System Interface and Adolescent Cohort
Time frame: Up to 10 days