CompletedNCT02280863Updated Jul 3, 2018Results posted

Hybrid Closed-Loop Hotel Studies With Medtronic PID Controller

An interventional study of Medtronic Hybrid Closed-loop System - Android Platform and Medtronic Hybrid Closed-loop Integrated System in Type 1 Diabetes, sponsored by Stanford University. Completed at 3 sites in United States. Open to participants aged 14 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-03.

Sponsored by Stanford University · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 24
Allocation: Non-randomized
Ages: 14 Years to 40 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Type 1 Diabetes

Browse trials for

Diabetes Mellitus, Type 1 3,522

In context

Diabetes Mellitus, Type 1

3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.

This study's enrollment of 24 is below the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 14 Years to 40 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Sequential assignment
Masking: None (open label)
Enrollment: 24 participants (actual)

Study arms

Experimental
Adult Cohort
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.
Device: Medtronic Hybrid Closed-loop System - Android Platform · Device: Medtronic Hybrid Closed-loop Integrated System
Experimental
Adolescent Cohort
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.
Device: Medtronic Hybrid Closed-loop Integrated System

Interventions

DeviceMedtronic Hybrid Closed-loop System - Android Platform
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.
DeviceMedtronic Hybrid Closed-loop Integrated System
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

What researchers measure

Primary outcomes

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

Secondary outcomes

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
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

Results

Posted Jul 3, 2018

Participant flow

Adults were recruited in the first 2 cohorts. Following analysis of the adult cohorts, adolescents were recruited in the third cohort.

Android Platform

Participant flow — Android Platform
Milestone	Adult Cohort	Adolescent Cohort
Started	8	0
Completed	8	0
Not completed	0	0

Integrated Platform

Participant flow — Integrated Platform
Milestone	Adult Cohort	Adolescent Cohort
Started	9	15
Completed	9	14
Not completed	0	1
Withdrew: Met stopping criteria	0	1

Outcome measures

PrimaryCount 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
Reported as:: Count of participants · Participants

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
Participants	Adult Cohort - Medtronic Android Interface	Adult Cohort - Integrated System Interface	Adolescent Cohort
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	0	0	1

SecondaryMean 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
Reported as:: Mean · mg/dL

Mean Glucose Values
mg/dL	Adult Cohort - Medtronic Android Interface	Adult Cohort - Integrated System Interface	Adolescent Cohort
Day (open loop)	151 ± 14	144 ± 15	171 ± 30
Day (closed loop)	156 ± 14	152 ± 14	153 ± 17
Night (open loop)	156 ± 26	142 ± 18	168 ± 39
Night (closed loop)	155 ± 22	148 ± 20	144 ± 19

SecondaryMean 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
Reported as:: Mean · mg/dL

Mean Glucose Values, Fingerstick Glucose Meter Value, Adult Cohorts
mg/dL	Adult Cohort - Medtronic Android Interface	Adult Cohort - Integrated System Interface
Open loop	148 ± 31	164 ± 41
Closed loop	127 ± 14	151 ± 36

SecondaryMedian 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
Reported as:: Median · mg/dL

Median Glucose Values, Fingerstick Glucose Meter Value, Adolescent Cohort
mg/dL	Adolescent Cohort
Open loop	181 (121 to 191)
Closed loop	132 (121 to 138)

SecondaryPercentage of Time Within Glucose Range of 70-180 mg/dL

Time frame:: Up to 10 days
Reported as:: Mean · percentage of time in range

Percentage of Time Within Glucose Range of 70-180 mg/dL
percentage of time in range	Adult Cohort - Medtronic Android Interface	Adult Cohort - Integrated System Interface	Adolescent Cohort
Open loop	71.9 ± 10.6	67.7 ± 8.1	55.2 ± 14.2
Closed loop	71.0 ± 12.4	71.8 ± 12.5	69.8 ± 9.7

SecondaryPercentage of Fingerstick Meter Glucose Value Tests <70 mg/dL

Time frame:: Up to 10 days
Reported as:: Mean · percentage of tests

Percentage of Fingerstick Meter Glucose Value Tests <70 mg/dL
percentage of tests	Adult Cohort - Medtronic Android Interface	Adult Cohort - Integrated System Interface	Adolescent Cohort
Open loop	4.7 ± 5.1	13.0 ± 9.7	11.7 ± 9.9
Closed loop	1.4 ± 1.7	7.6 ± 2.9	13.5 ± 13.9

SecondaryPercentage of Time With Sensor Glucose Values <70 mg/DL, Adult Cohorts

Time frame:: Up to 10 days
Reported as:: Mean · percentage of time

Percentage of Time With Sensor Glucose Values <70 mg/DL, Adult Cohorts
percentage of time	Adult Cohort - Medtronic Android Interface	Adult Cohort - Integrated System Interface
Day (open loop)	2.7 ± 1.3	7.6 ± 5.4
Day (closed loop)	1.4 ± 1.8	2.0 ± 1.4
Night (open loop)	3.5 ± 4.3	8.2 ± 8.7
Night (closed loop)	1.9 ± 3.4	1.2 ± 1.7

SecondaryPercentage of Time With Sensor Glucose Values <70 mg/DL, Adolescent Cohort

Time frame:: Up to 10 days
Reported as:: Median · percentage of time

Percentage of Time With Sensor Glucose Values <70 mg/DL, Adolescent Cohort
percentage of time	Adolescent Cohort
Day (open loop)	2.7 (0.8 to 9.2)
Day (closed loop)	2.5 (1.7 to 3.5)
Night (open loop)	2.5 (0.5 to 4.7)
Night (closed loop)	0.7 (0.0 to 4.2)

SecondaryPercentage of Fingerstick Meter Glucose Value Tests >300 mg/dL, Adult Cohort - Medtronic Android Interface

Time frame:: Up to 10 days
Reported as:: Median · percentage of readings

Percentage of Fingerstick Meter Glucose Value Tests >300 mg/dL, Adult Cohort - Medtronic Android Interface
percentage of readings	Adult Cohort - Medtronic Android Interface
Open loop	0.0 (0.0 to 3.3)
Closed loop	0.7 (0.0 to 3.6)

SecondaryPercentage of Fingerstick Meter Glucose Value Tests >300 mg/dL, Adult Cohort - Integrated System Interface and Adolescent Cohort

Time frame:: Up to 10 days
Reported as:: Mean · percentage of readings

Percentage of Fingerstick Meter Glucose Value Tests >300 mg/dL, Adult Cohort - Integrated System Interface and Adolescent Cohort
percentage of readings	Adult Cohort - Integrated System Interface	Adolescent Cohort
Open loop	3.0 ± 4.3	8.9 ± 9.8
Closed loop	3.1 ± 2.5	6.7 ± 9.2

Adverse events

Collected over Up to 10 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Adult Cohort	—	0/9 (0%)	0/9 (0%)
Adolescent Cohort	—	0/15 (0%)	1/15 (6.7%)

Most frequent other events

Most frequent other events
Event	Adult Cohort	Adolescent Cohort
HypoglycaemiaEndocrine disorders	0/9	1/15

Baseline characteristics

Age, Customized
Age, Customized(Participants)	Adult Cohort	Adolescent Cohort	Total
0-12 year	0	0	0
13-17 years	0	15	15
18-64 years	9	0	9
65 year and older	0	0	0

Sex: Female, Male
Sex: Female, Male(Participants)	Adult Cohort	Adolescent Cohort	Total
Female	8	9	17
Male	1	6	7

Study locations

3 sites

Stanford University Medical Center
Stanford, California 94305, United States
UC Denver- Barbara Davis Center for Childhood Diabetes
Aurora, Colorado 80045, United States
Yale University- Department of Pediatric Endocrinology
New Haven, Connecticut 06520, United States

References and documents

Publications

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. PubMed 27191182 ↗
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. PubMed 30239219 ↗

Individual participant data

Plan to share: Yes — There were three sites involved with the study; de-identified information was shared with the Denver and Yale sites.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 3, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02280863
Lead sponsor: Stanford University
Responsible party: Bruce A. Buckingham (Principle Investigator, Stanford University) — Principal investigator
First posted: Nov 2, 2014
Start date: Jul 2014
Primary completion: May 2015
Completion: May 2015
Results posted: Jul 3, 2018
Last update: Jul 3, 2018

Study contacts

Bruce A Buckingham, MD

principal investigator · Stanford University

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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