Type 1 DiabetesNCT02463097
Hybrid Closed Loop Pivotal Trial in Type 1 Diabetes
A study testing Insulin Pump in people with Type 1 Diabetes, run by Medtronic MiniMed, Inc. at 10 sites in 2 countries.
Trial summary
This study is a single-arm, multi-center, Home and Hotel Clinical Investigation in subjects with type 1 diabetes on insulin pump therapy. The purpose of this study is to demonstrate that the closed loop algorithm that is built into the 670G insulin pump is safe as part of the overall system. Read more about this study
- Who is it for?
- Ages 14 to 75 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Insulin Pump
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Jun 2015to Oct 2018
- 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 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Is age 14 - 75 years at time of screening
- Has a clinical diagnosis of type 1 diabetes for 2 years or more as determined via medical record or source documentation by an individual qualified to make a medical diagnosis
- Is willing to participate in a hotel study for the specified duration of hotel stay.
- Must have companion who will sleep in the same dwelling place every night during the study period and should also be able to call the subject daily in the event the subject is traveling.
- Is willing to perform ≥ 4 finger stick blood glucose measurements daily
- Is willing to perform required sensor calibrations
Show all 26Show fewer
- Is willing to wear the system continuously throughout the study
- Has a Glycosylated hemoglobin (A1C) value less than 10.0% (as processed by Central Lab) at time of screening visit
- Has TSH in the normal range OR if the TSH is out of normal reference range the Free T3 is below or within the lab's reference range and Free T4 is within the normal reference range.
- Pump therapy for greater than 6 months prior to screening (with or without CGM experience)
- Is willing to upload data from the study pump, must have Internet access and a computer system that meets the requirements for uploading the study pump
- If subject has celiac disease, it has been adequately treated as determined by the investigator
- Is willing to take one of the following insulins and can financially support the use of either of the 2 insulin preparations throughout the course of the study (i.e. co-payments for insulin with insurance or able to pay full amount)
- Humalog® (insulin lispro injection)
- NovoLog® (insulin aspart)
- With history of cardiovascular event 1 year or more from the time of screening must have an EKG within 6 months prior to screening or during screening. If subject has an abnormal EKG, participation is allowed if there is clearance from a cardiologist
- With 3 or more cardiovascular risk factors listed below must have an EKG within 6 months prior to screening or during screening. If subject has an abnormal EKG, participation is allowed if there is clearance from a cardiologist
- Cardiovascular risk factors include:
- Age >35 years
- Type 1 diabetes of >15 years' duration
- Presence of any additional risk factor for coronary artery disease
- Presence of microvascular disease (proliferative retinopathy or nephropathy, including microalbuminuria)
- Presence of peripheral vascular disease
- Presence of autonomic neuropathy
- With history of cardiovascular event 1 year or more from the time of screening must have a stress test within 6 months prior to screening or during run in period. If subject fails stress test, participation is allowed if there is clearance from a cardiologist
- Must be able to speak and be literate in English
Who cannot join
- Has a history of 2 or more episodes of severe hypoglycemia, which resulted in any the following during the 6 months prior to screening:
- Medical assistance (i.e. Paramedics, Emergency Room ( ER) or Hospitalization)
- Coma
- Seizures
- Is unable to tolerate tape adhesive in the area of sensor placement
- Has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection)
Show all 28Show fewer
- Females who are sexually active and able to conceive will be excluded if they are not using an effective method of contraception and do not agree to continue using an effective method of contraception for the duration of the study as determined by investigator.
- Has had any of the following cardiovascular events within 1 year of screening: myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, ventricular rhythm disturbances or thromboembolic disease
- Is being treated for hyperthyroidism at time of screening
- Has diagnosis of adrenal insufficiency
- Has had DKA in the 6 months prior to screening visit.
- Has taken any oral, injectable, or intravenous (IV) steroids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV steroids during the course of the study
- Actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 2 weeks
- Has been hospitalized or has visited the ER in the 6 months prior to screening resulting in a primary diagnosis of uncontrolled diabetes
- Currently abusing illicit drugs
- Currently abusing marijuana.
- Currently abusing prescription drugs
- Currently abusing alcohol
- Using pramlintide (Symlin), DPP-4 inhibitor, liraglutide (Victoza or other GLP-1 agonists), metformin, canagliflozin (Invokana or other SGLT2 inhibitors) at time of screening
- Has a history of visual impairment which would not allow subject to participate in the study and perform all study procedures safely, as determined by the investigator
- Has elective surgery planned that requires general anesthesia during the course of the study
- Has a sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening
- Plans to receive red blood cell transfusion or erythropoietin over the course of study participation
- Diagnosed with current eating disorder such as anorexia or bulimia
- Diagnosed with chronic kidney disease that results in chronic anemia
- Hematocrit that is below the normal reference range of lab used.
- On dialysis
- Serum creatinine of >2 mg/dL.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States9 sites
Atlanta Diabetes Associates
Atlanta, Georgia, 30318
Barbara Davis Center for Childhood Diabetes (Adult)
Aurora, Colorado, 80045
Barbara Davis Center for Childhood Diabetes (Pediatric)
Aurora, Colorado, 80045
University of Virginia
Charlottesville, Virginia, 22903
AMCR Institute
Escondido, California, 92026
Park Nicollet Clinic-International Diabetes Center - Adult and Pediatric
Minneapolis, Minnesota, 55416
Yale University School of Medicine
New Haven, Connecticut, 06520
Stanford University Medical Center
Palo Alto, California, 94035
Rainer Clinical Research Center
Renton, Washington, 98057
About this study
Official title: Safety Evaluation of the Hybrid Closed Loop (HCL) System in Type 1 Diabetes
This study is a single-arm, multi-center, Home and Hotel Clinical Investigation in subjects with type 1 diabetes on insulin pump therapy. The purpose of this study is to demonstrate that the closed loop algorithm that is built into the 670G insulin pump is safe as part of the overall system.
Read the detailed description
The study will proceed as follows:
Run-in Period:
A total of up to 150 subjects (age 14 - 75) will be enrolled at up to 10 investigational centers (9 in the US, 1 in the Europe, Middle East and Africa (EMEA) region) in order to reach 100 subjects who will complete the HCL study. The 2-week run-in period will be used to allow subjects to become familiar with new study devices. During the two week run-in period subjects will be using the Study Pump (670G) with the Sensor Augmented Pump function only activated (i.e. SmartGuard OFF and HCL OFF).
Study Period - At Home:
Following the two week run-in period using the Study Pump (670G), all subjects will participate in a 3-month study period.
Subjects will be required to have a companion with them during the night for the duration of the study period. Companions will need to be under the same roof, but not necessarily in the same bedroom. During the Hotel stay where subjects are monitored closely, the presence of a companion is not necessary.
Study Period - Hotel Study Subjects will participate in a Hotel study (6 days, 5 nights), with the remainder of the study period to be spent at home.
All subjects will undergo daytime and nighttime Frequent Sample Testing (FST) for approximately 24 hours during the Hotel study with YSI or i-STAT® used as a reference value.
With respect to meals, subjects will be allowed to eat as they normally do.
Continued Access Program Subjects will be given the opportunity to extend use of their study devices for a period of 3 years. If subjects choose to participate in the continuation period, they will retain the study devices at the end of study period visit or receive them back in the event they have been returned to study staff already. During the continuation period, subjects will come in for office visits every 3 months. At each of the quarterly visits, subjects will be asked about the occurrence of adverse events and device complaints.
- Conditions
- Type 1 Diabetes
- Being tested
- Insulin Pump
- 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.
Insulin PumpDevice
Also called MMT-670G
Closed Loop Algorithm
| Study group | Role | What they receive |
|---|---|---|
| Study Arm | Experimental | All subjects wearing the MMT-670G insulin pump, using it with the closed loop algorithm Receives: Device: Insulin Pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in A1C
There is no statistically powered primary endpoint in this study. However, there will be a descriptive analysis of change in A1C.
Measured: Baseline and 3 months
Secondary outcomes (2)
Number of Severe Hypoglycemia Events
There is no statistically powered secondary endpoint in this study. However, there will be a descriptive analysis of the number of Severe Hypoglycemia events.
Measured: 3 months
Number of Diabetic Ketoacidosis (DKA) Events
There is no statistically powered secondary endpoint in this study. However, there will be a descriptive analysis on number of Diabetic Ketoacidosis (DKA) Event.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionMar 2016
- Study completionOct 2018
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic MiniMed, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02463097
- Sponsor's protocol ID
- CEP 294
- Status last verified
- Apr 2019
- First submitted
- 28 May 2015
- Last updated
- 16 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Cordero TL, Garg SK, Brazg R, Bailey TS, Shin J, Lee SW, Kaufman FR. The Effect of Prior Continuous Glucose Monitoring Use on Glycemic Outcomes in the Pivotal Trial of the MiniMed 670G Hybrid Closed-Loop System. Diabetes Technol Ther. 2017 Dec;19(12):749-752. doi: 10.1089/dia.2017.0208. Epub 2017 Nov 17.
PubMed 29148821Garg SK, Weinzimer SA, Tamborlane WV, Buckingham BA, Bode BW, Bailey TS, Brazg RL, Ilany J, Slover RH, Anderson SM, Bergenstal RM, Grosman B, Roy A, Cordero TL, Shin J, Lee SW, Kaufman FR. Glucose Outcomes with the In-Home Use of a Hybrid Closed-Loop Insulin Delivery System in Adolescents and Adults with Type 1 Diabetes. Diabetes Technol Ther. 2017 Mar;19(3):155-163. doi: 10.1089/dia.2016.0421. Epub 2017 Jan 30.
PubMed 28134564
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Evaluation of the Hybrid Closed Loop (HCL) System in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT02463097
- Acronym / sponsor ID
- CEP 294
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Medtronic MiniMed, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 4 Jun 2015 (estimated)
- Results
- Posted 18 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a single-arm, multi-center, Home and Hotel Clinical Investigation in subjects with type 1 diabetes on insulin pump therapy. The purpose of this study is to demonstrate that the closed loop algorithm that is built into the 670G insulin pump is safe as part of the overall system.
Detailed description
The study will proceed as follows:
Run-in Period:
A total of up to 150 subjects (age 14 - 75) will be enrolled at up to 10 investigational centers (9 in the US, 1 in the Europe, Middle East and Africa (EMEA) region) in order to reach 100 subjects who will complete the HCL study. The 2-week run-in period will be used to allow subjects to become familiar with new study devices. During the two week run-in period subjects will be using the Study Pump (670G) with the Sensor Augmented Pump function only activated (i.e. SmartGuard OFF and HCL OFF).
Study Period - At Home:
Following the two week run-in period using the Study Pump (670G), all subjects will participate in a 3-month study period.
Subjects will be required to have a companion with them during the night for the duration of the study period. Companions will need to be under the same roof, but not necessarily in the same bedroom. During the Hotel stay where subjects are monitored closely, the presence of a companion is not necessary.
Study Period - Hotel Study Subjects will participate in a Hotel study (6 days, 5 nights), with the remainder of the study period to be spent at home.
All subjects will undergo daytime and nighttime Frequent Sample Testing (FST) for approximately 24 hours during the Hotel study with YSI or i-STAT® used as a reference value.
With respect to meals, subjects will be allowed to eat as they normally do.
Continued Access Program Subjects will be given the opportunity to extend use of their study devices for a period of 3 years. If subjects choose to participate in the continuation period, they will retain the study devices at the end of study period visit or receive them back in the event they have been returned to study staff already. During the continuation period, subjects will come in for office visits every 3 months. At each of the quarterly visits, subjects will be asked about the occurrence of adverse events and device complaints.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Arm | Experimental | Device: Insulin PumpAll subjects wearing the MMT-670G insulin pump, using it with the closed loop algorithm |
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (26 listed)
- Is age 14 - 75 years at time of screening
- Has a clinical diagnosis of type 1 diabetes for 2 years or more as determined via medical record or source documentation by an individual qualified to make a medical diagnosis
- Is willing to participate in a hotel study for the specified duration of hotel stay.
- Must have companion who will sleep in the same dwelling place every night during the study period and should also be able to call the subject daily in the event the subject is traveling.
- Is willing to perform ≥ 4 finger stick blood glucose measurements daily
Key exclusion criteria (28 listed)
- Has a history of 2 or more episodes of severe hypoglycemia, which resulted in any the following during the 6 months prior to screening:
- Is unable to tolerate tape adhesive in the area of sensor placement
- Has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection)
- Females who are sexually active and able to conceive will be excluded if they are not using an effective method of contraception and do not agree to continue using an effective method of contraception for the duration of the study as determined by investigator.
- Has had any of the following cardiovascular events within 1 year of screening: myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, ventricular rhythm disturbances 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 |
|---|---|---|
| Insulin PumpAlso: MMT-670GClosed Loop Algorithm | Device | Study Arm |
Primary outcome
Change in A1C
Time frame: Baseline and 3 months
There is no statistically powered primary endpoint in this study. However, there will be a descriptive analysis of change in A1C.
2 secondary outcomes
Number of Severe Hypoglycemia Events
Time frame: 3 months
Number of Diabetic Ketoacidosis (DKA) Events
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29148821Cordero TL, Garg SK, Brazg R, Bailey TS, Shin J, Lee SW, Kaufman FR. The Effect of Prior Continuous Glucose Monitoring Use on Glycemic Outcomes in the Pivotal Trial of the MiniMed 670G Hybrid Closed-Loop System. Diabetes Technol Ther. 2017 Dec;19(12):749-752. doi: 10.1089/dia.2017.0208. Epub 2017 Nov 17.
- Derived from this study: PubMed 28134564Garg SK, Weinzimer SA, Tamborlane WV, Buckingham BA, Bode BW, Bailey TS, Brazg RL, Ilany J, Slover RH, Anderson SM, Bergenstal RM, Grosman B, Roy A, Cordero TL, Shin J, Lee SW, Kaufman FR. Glucose Outcomes with the In-Home Use of a Hybrid Closed-Loop Insulin Delivery System in Adolescents and Adults with Type 1 Diabetes. Diabetes Technol Ther. 2017 Mar;19(3):155-163. doi: 10.1089/dia.2016.0421. Epub 2017 Jan 30.
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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.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insulin Pump in people with Type 1 Diabetes, run by Medtronic MiniMed, Inc. at 10 sites in 2 countries.
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 26 inclusion and 28 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 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Israel. 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 18 Apr 2017). 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?
Change in A1C (time frame: Baseline and 3 months). 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 NCT02463097, 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 16 Apr 2019.