Type 1 DiabetesNCT02280863
Hybrid Closed-Loop Hotel Studies With Medtronic PID Controller
A study testing Medtronic Hybrid Closed-loop System - Android Platform and Medtronic Hybrid Closed-loop Integrated System in people with Type 1 Diabetes, run by Stanford University at 3 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 14 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Medtronic Hybrid Closed-loop System - Android Platform and Medtronic Hybrid Closed-loop Integrated System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2014to May 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
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- 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).
Who cannot join
- 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)
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- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
UC Denver- Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, 80045
Yale University- Department of Pediatric Endocrinology
New Haven, Connecticut, 06520
Stanford University Medical Center
Stanford, California, 94305
About this study
Official title: Hybrid Closed-Loop Studies With Medtronic PID Controller- Hotel HCL Study
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
- Type 1 Diabetes
- Being tested
- Medtronic Hybrid Closed-loop System - Android Platform, Medtronic Hybrid Closed-loop Integrated System
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic Hybrid Closed-loop System - Android PlatformDevice
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.
Medtronic Hybrid Closed-loop Integrated SystemDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Medtronic Hybrid Closed-loop System - Android Platform; Device: Medtronic Hybrid Closed-loop Integrated System |
| 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. Receives: Device: Medtronic Hybrid Closed-loop Integrated System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 10 days
Secondary outcomes (9)
Mean Glucose Values
Mean glucose values are reported as assessed by continuous glucose monitoring (CGM; subcutaneous sensor, day and night values).
Measured: 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.
Measured: 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.
Measured: Up to 10 days
Percentage of Time Within Glucose Range of 70-180 mg/dL
Measured: Up to 10 days
Percentage of Fingerstick Meter Glucose Value Tests <70 mg/dL
Measured: Up to 10 days
Percentage of Time With Sensor Glucose Values <70 mg/DL, Adult Cohorts
Measured: Up to 10 days
Percentage of Time With Sensor Glucose Values <70 mg/DL, Adolescent Cohort
Measured: Up to 10 days
Percentage of Fingerstick Meter Glucose Value Tests >300 mg/dL, Adult Cohort - Medtronic Android Interface
Measured: Up to 10 days
Percentage of Fingerstick Meter Glucose Value Tests >300 mg/dL, Adult Cohort - Integrated System Interface and Adolescent Cohort
Measured: Up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2014 (estimated)
- Study startJul 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruce A. Buckingham, Stanford University
- Investigators
- Bruce A Buckingham, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02280863
- Sponsor's protocol ID
- IDE: G140086
- Other IDs
- 1-SRA-2014-238-, IRB 29973
- Status last verified
- Jun 2018
- First submitted
- 9 Jul 2014
- Last updated
- 3 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: There were three sites involved with the study; de-identified information was shared with the Denver and Yale sites.
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 27191182Adams 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hybrid Closed-Loop Studies With Medtronic PID Controller- Hotel HCL Study
- ClinicalTrials.gov ID
- NCT02280863
- Acronym / sponsor ID
- IDE: G140086
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 3 Nov 2014 (estimated)
- Results
- Posted 3 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adult Cohort | Experimental | Device: Medtronic Hybrid Closed-loop System - Android Platform, Device: Medtronic Hybrid Closed-loop Integrated SystemMedtronic 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 | Device: Medtronic Hybrid Closed-loop Integrated SystemMedtronic Hybrid Closed-Loop System will be used by adolescents for four days in open-loop (sensor augmented pump) and four days in closed-loop. |
Who may qualify
- Ages
- 14 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medtronic Hybrid Closed-loop System - Android PlatformA 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. | Device | Adult Cohort |
| Medtronic Hybrid Closed-loop Integrated SystemA 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 | Device | Adolescent Cohort, Adult Cohort |
Primary outcome
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
Time frame: Up to 10 days
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
9 secondary outcomes
Mean Glucose Values
Time frame: Up to 10 days
Mean Glucose Values, Fingerstick Glucose Meter Value, Adult Cohorts
Time frame: Up to 10 days
Median Glucose Values, Fingerstick Glucose Meter Value, Adolescent Cohort
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 and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27191182Ly 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.
- Derived from this study: PubMed 30239219Adams 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.
- Individual participant dataSharing planned: Yes. There were three sites involved with the study; de-identified information was shared with the Denver and Yale sites.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce A Buckingham, MD principal investigator
Stanford University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medtronic Hybrid Closed-loop System - Android Platform and Medtronic Hybrid Closed-loop Integrated System in people with Type 1 Diabetes, run by Stanford University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Up to 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02280863, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2018.