Hybrid Closed-Loop Hotel Studies With Medtronic PID Controller
Primary Purpose
Type 1 Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Medtronic Hybrid Closed-loop System - Android Platform
Medtronic Hybrid Closed-loop Integrated System
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of type 1 diabetes (The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.)
- Daily insulin therapy for at least one year
- Age between 14.0 to 40.0 years of age. The first 9 subjects (between all 3 centers) will be over 18 years old.
- Subject has performed an average of at least 3 meter glucose readings per day in the preceding 2 weeks
- Subject has used a downloadable insulin pump for at least 3 months
- Subject comprehends written English
- Female patients who are sexually active must be on acceptable method of contraception e.g. oral contraceptive pill, diaphragm, IUD
- Female patients must have a negative urine pregnancy test
- Informed Consent Form signed by the subject and/or parent and assent signed by the subject if < age 18
- Parent/guardian (for subjects < 18 years) and subject understand the study protocol and agree to comply with it. Both parents must sign if possible.
- Total daily insulin requirement greater than 0.4 units/kg/day over the preceding two weeks.
- No expectation that subject will be moving out of the area of the clinical center during the study.
- Adults will need to be working within 20 minutes of our research staff during the day.
- A person willing to fulfill the role of a remote monitor (such as parent, spouse or significant other).
Exclusion Criteria:
- Subject has a medical disorder that in the judgment of the investigator will affect the wearing of the devices or the completion of any aspect of the protocol
- Diabetic ketoacidosis in the past month
- History of seizure or loss of consciousness in the last 6 months
- Subject has a respiratory condition such as asthma, treated with systemic or inhaled corticosteroids in the previous 6 months or cystic fibrosis
- Subject has a history of any cardiac or vascular disorder such as myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, arrhythmia or thromboembolic disease
- Subject has a history of liver or kidney disease (other than microalbuminuria)
- Systolic blood pressure > 140 mmHg on screening visit
- Diastolic blood pressure > 90 mmHg on screening visit
- Subject has active Graves' disease
- Subjects with inadequately treated thyroid disease or celiac disease
- Subject has a neurologic disorder that in the judgment of the investigator will affect completion of the protocol
- Either the subject or the subject's primary caregiver has received inpatient psychiatric treatment in the past 6 months
- Subject has a history of diagnosed medical eating disorder
- Subject has a history of known illicit drug abuse
- Subject has a history of known prescription drug abuse
- Subject has a history of current alcohol abuse
- Subject has a history of visual impairment which would not allow subject to participate
- Subject has an active skin condition that would affect sensor placement
- Subject has adhesive allergies
- Subjects requiring an intermediate or long-acting insulin (such as NPH, detemir or glargine)
- Subjects requiring other anti-diabetic medications other than insulin (oral or injectable)
- Current use of oral/inhaled glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study
- Subject is currently on beta blocker medication
- Subject is currently participating in another investigational study (drug or device)
- Subject is deemed by the investigator to be unwilling or unable to follow the protocol
Sites / Locations
- Stanford University Medical Center
- UC Denver- Barbara Davis Center for Childhood Diabetes
- Yale University- Department of Pediatric Endocrinology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Adult Cohort
Adolescent Cohort
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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:
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 that are unrelated to an infusion set failure
No ketonemia >1.0 mmol/L, while the system is functional unless related to an intercurrent illness or infusion set failure
No seizures or loss of consciousness while system is on and functional
Secondary Outcome Measures
Mean Glucose Values
Mean glucose values are reported as assessed by continuous glucose monitoring (CGM; subcutaneous sensor, day and night values).
Mean Glucose Values, Fingerstick Glucose Meter Value, Adult Cohorts
Mean glucose values are reported as assessed by fingerstick glucose meter value.
Median Glucose Values, Fingerstick Glucose Meter Value, Adolescent Cohort
Median an glucose values are reported as assessed by fingerstick glucose meter value.
Percentage of Time Within Glucose Range of 70-180 mg/dL
Percentage of Fingerstick Meter Glucose Value Tests <70 mg/dL
Percentage of Time With Sensor Glucose Values <70 mg/DL, Adult Cohorts
Percentage of Time With Sensor Glucose Values <70 mg/DL, Adolescent Cohort
Percentage of Fingerstick Meter Glucose Value Tests >300 mg/dL, Adult Cohort - Medtronic Android Interface
Percentage of Fingerstick Meter Glucose Value Tests >300 mg/dL, Adult Cohort - Integrated System Interface and Adolescent Cohort
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02280863
Brief Title
Hybrid Closed-Loop Hotel Studies With Medtronic PID Controller
Official Title
Hybrid Closed-Loop Studies With Medtronic PID Controller- Hotel HCL Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Adult Cohort
Arm Type
Experimental
Arm Description
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.
Arm Title
Adolescent Cohort
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Medtronic Hybrid Closed-loop System - Android Platform
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Medtronic Hybrid Closed-loop Integrated System
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Description
Our definition of a subject successfully participating in a cohort is:
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 that are unrelated to an infusion set failure
No ketonemia >1.0 mmol/L, while the system is functional unless related to an intercurrent illness or infusion set failure
No seizures or loss of consciousness while system is on and functional
Time Frame
Up to 10 days
Secondary Outcome Measure Information:
Title
Mean Glucose Values
Description
Mean glucose values are reported as assessed by continuous glucose monitoring (CGM; subcutaneous sensor, day and night values).
Time Frame
Up to 10 days
Title
Mean Glucose Values, Fingerstick Glucose Meter Value, Adult Cohorts
Description
Mean glucose values are reported as assessed by fingerstick glucose meter value.
Time Frame
Up to 10 days
Title
Median Glucose Values, Fingerstick Glucose Meter Value, Adolescent Cohort
Description
Median an glucose values are reported as assessed by fingerstick glucose meter value.
Time Frame
Up to 10 days
Title
Percentage of Time Within Glucose Range of 70-180 mg/dL
Time Frame
Up to 10 days
Title
Percentage of Fingerstick Meter Glucose Value Tests <70 mg/dL
Time Frame
Up to 10 days
Title
Percentage of Time With Sensor Glucose Values <70 mg/DL, Adult Cohorts
Time Frame
Up to 10 days
Title
Percentage of Time With Sensor Glucose Values <70 mg/DL, Adolescent Cohort
Time Frame
Up to 10 days
Title
Percentage of Fingerstick Meter Glucose Value Tests >300 mg/dL, Adult Cohort - Medtronic Android Interface
Time Frame
Up to 10 days
Title
Percentage of Fingerstick Meter Glucose Value Tests >300 mg/dL, Adult Cohort - Integrated System Interface and Adolescent Cohort
Time Frame
Up to 10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of type 1 diabetes (The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.)
Daily insulin therapy for at least one year
Age between 14.0 to 40.0 years of age. The first 9 subjects (between all 3 centers) will be over 18 years old.
Subject has performed an average of at least 3 meter glucose readings per day in the preceding 2 weeks
Subject has used a downloadable insulin pump for at least 3 months
Subject comprehends written English
Female patients who are sexually active must be on acceptable method of contraception e.g. oral contraceptive pill, diaphragm, IUD
Female patients must have a negative urine pregnancy test
Informed Consent Form signed by the subject and/or parent and assent signed by the subject if < age 18
Parent/guardian (for subjects < 18 years) and subject understand the study protocol and agree to comply with it. Both parents must sign if possible.
Total daily insulin requirement greater than 0.4 units/kg/day over the preceding two weeks.
No expectation that subject will be moving out of the area of the clinical center during the study.
Adults will need to be working within 20 minutes of our research staff during the day.
A person willing to fulfill the role of a remote monitor (such as parent, spouse or significant other).
Exclusion Criteria:
Subject has a medical disorder that in the judgment of the investigator will affect the wearing of the devices or the completion of any aspect of the protocol
Diabetic ketoacidosis in the past month
History of seizure or loss of consciousness in the last 6 months
Subject has a respiratory condition such as asthma, treated with systemic or inhaled corticosteroids in the previous 6 months or cystic fibrosis
Subject has a history of any cardiac or vascular disorder such as myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, arrhythmia or thromboembolic disease
Subject has a history of liver or kidney disease (other than microalbuminuria)
Systolic blood pressure > 140 mmHg on screening visit
Diastolic blood pressure > 90 mmHg on screening visit
Subject has active Graves' disease
Subjects with inadequately treated thyroid disease or celiac disease
Subject has a neurologic disorder that in the judgment of the investigator will affect completion of the protocol
Either the subject or the subject's primary caregiver has received inpatient psychiatric treatment in the past 6 months
Subject has a history of diagnosed medical eating disorder
Subject has a history of known illicit drug abuse
Subject has a history of known prescription drug abuse
Subject has a history of current alcohol abuse
Subject has a history of visual impairment which would not allow subject to participate
Subject has an active skin condition that would affect sensor placement
Subject has adhesive allergies
Subjects requiring an intermediate or long-acting insulin (such as NPH, detemir or glargine)
Subjects requiring other anti-diabetic medications other than insulin (oral or injectable)
Current use of oral/inhaled glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study
Subject is currently on beta blocker medication
Subject is currently participating in another investigational study (drug or device)
Subject is deemed by the investigator to be unwilling or unable to follow the protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce A Buckingham, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
UC Denver- Barbara Davis Center for Childhood Diabetes
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Yale University- Department of Pediatric Endocrinology
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
There were three sites involved with the study; de-identified information was shared with the Denver and Yale sites.
Citations:
PubMed Identifier
27191182
Citation
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.
Results Reference
result
PubMed Identifier
30239219
Citation
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.
Results Reference
derived
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Hybrid Closed-Loop Hotel Studies With Medtronic PID Controller
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