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Hybrid Closed Loop Pivotal Trial in Type 1 Diabetes

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Diabetes
ClinicalTrials.gov Identifier:
NCT02463097
First received: May 28, 2015
Last updated: May 12, 2017
Last verified: May 2017
  Purpose
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.

Condition Intervention
Type 1 Diabetes Device: Insulin Pump Other: i-STAT blood testing Other: Blood Glucose Meter testing

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety Evaluation of the Hybrid Closed Loop (HCL) System in Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by Medtronic Diabetes:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Number of Severe Hypoglycemia Events [ Time Frame: 3 months ]
    There is no statistically powered secondary endpoint in this study. However, there will be a descriptive analysis of the number of Severe Hypoglycemia events.

  • Number of Diabetic Ketoacidosis (DKA) Events [ Time Frame: 3 months ]
    There is no statistically powered secondary endpoint in this study. However, there will be a descriptive analysis on number of Diabetic Ketoacidosis (DKA) Event.


Enrollment: 124
Study Start Date: June 2015
Estimated Study Completion Date: May 2018
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study Arm
All subjects wearing the MMT-670G insulin pump, using it with the closed loop algorithm
Device: Insulin Pump
Closed Loop Algorithm
Other Name: MMT-670G
Other: i-STAT blood testing
Intravenous i-STAT blood testing is used for reference validation
Other: Blood Glucose Meter testing
Frequent finger stick blood glucose testing using a Blood Glucose meter is required

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 2 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.

  Eligibility

Ages Eligible for Study:   14 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Is age 14 - 75 years at time of screening
  2. 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
  3. Is willing to participate in a hotel study for the specified duration of hotel stay.
  4. 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.
  5. Is willing to perform ≥ 4 finger stick blood glucose measurements daily
  6. Is willing to perform required sensor calibrations
  7. Is willing to wear the system continuously throughout the study
  8. Has a Glycosylated hemoglobin (A1C) value less than 10.0% (as processed by Central Lab) at time of screening visit
  9. 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.
  10. Pump therapy for greater than 6 months prior to screening (with or without CGM experience)
  11. 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
  12. If subject has celiac disease, it has been adequately treated as determined by the investigator
  13. 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)
  14. 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
  15. 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
  16. 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
  17. Must be able to speak and be literate in English

Exclusion Criteria:

  1. 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
  2. Is unable to tolerate tape adhesive in the area of sensor placement
  3. Has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection)
  4. 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.
  5. 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
  6. Is being treated for hyperthyroidism at time of screening
  7. Has diagnosis of adrenal insufficiency
  8. Has had DKA in the 6 months prior to screening visit.
  9. 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
  10. 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
  11. Has been hospitalized or has visited the ER in the 6 months prior to screening resulting in a primary diagnosis of uncontrolled diabetes
  12. Currently abusing illicit drugs
  13. Currently abusing marijuana.
  14. Currently abusing prescription drugs
  15. Currently abusing alcohol
  16. Using pramlintide (Symlin), DPP-4 inhibitor, liraglutide (Victoza or other GLP-1 agonists), metformin, canagliflozin (Invokana or other SGLT2 inhibitors) at time of screening
  17. 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
  18. Has elective surgery planned that requires general anesthesia during the course of the study
  19. Has a sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening
  20. Plans to receive red blood cell transfusion or erythropoietin over the course of study participation
  21. Diagnosed with current eating disorder such as anorexia or bulimia
  22. Diagnosed with chronic kidney disease that results in chronic anemia
  23. Hematocrit that is below the normal reference range of lab used.
  24. On dialysis
  25. Serum creatinine of >2 mg/dL.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02463097

Locations
United States, California
AMCR Institute
Escondido, California, United States, 92026
Stanford University Medical Center
Palo Alto, California, United States, 94035
United States, Colorado
Barbara Davis Center for Childhood Diabetes (Adult)
Aurora, Colorado, United States, 80045
Barbara Davis Center for Childhood Diabetes (Pediatric)
Aurora, Colorado, United States, 80045
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
United States, Georgia
Atlanta Diabetes Associates
Atlanta, Georgia, United States, 30318
United States, Minnesota
Park Nicollet Clinic-International Diabetes Center - Adult and Pediatric
Minneapolis, Minnesota, United States, 55416
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22903
United States, Washington
Rainer Clinical Research Center
Renton, Washington, United States, 98057
Israel
Institute of Endocrinology, Sheba Medical Center
Tel Aviv, Israel, 52621
Sponsors and Collaborators
Medtronic Diabetes
  More Information

Responsible Party: Medtronic Diabetes
ClinicalTrials.gov Identifier: NCT02463097     History of Changes
Other Study ID Numbers: CEP 294
Study First Received: May 28, 2015
Results First Received: March 7, 2017
Last Updated: May 12, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 21, 2017