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Safety Evaluation of the Hybrid Closed Loop (HCL) System in Pediatric Subjects With Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT02660827
Recruitment Status : Active, not recruiting
First Posted : January 21, 2016
Results First Posted : January 11, 2019
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic Diabetes

Brief Summary:
This study is a single-arm, multi-center, Home and Hotel Clinical Investigation in pediatric subjects with type 1 diabetes on insulin pump therapy. The purpose of this study is to demonstrate that the closed loop algorithm is safe as part of the overall system, and to assess the PLGM feature in 7-13 years old subjects.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Device: Insulin Pump Not Applicable

Detailed Description:

The study will proceed as follows:

Run-in Period - General:

A total of up to 200 subjects (age 2-13) will be enrolled at up to 15 investigational centers (14 in the US, 1 EMEA) in order to reach 120 subjects who will complete the HCL study.

Study Period - At Home:

Following the two week run-in period using the Study Pump (670G), all subjects (age 2-13) will participate in a 3-month study period.

Study Period - Hotel Study Subjects (age 7-13) will participate in a Hotel study (6 days, 5 nights), with the remainder of the study period to be spent at home. Subjects 2-6 years of age are not required to participate in a hotel study. Instead, they will participate in an out-of-home study for 5 consecutive days, 4-6 hours per day.

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety Evaluation of the Hybrid Closed Loop (HCL) System in Pediatric Subjects With Type 1 Diabetes
Actual Study Start Date : April 18, 2016
Actual Primary Completion Date : November 28, 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Hybrid closed loop
All subjects will be wearing the MMT-670G insulin pump, using it with the closed loop algorithm
Device: Insulin Pump
Closed Loop Algorithm
Other Name: MMT-670G




Primary Outcome Measures :
  1. Age 7-13 Years Old Subjects Change in A1C [ Time Frame: Baseline and end of 3-month treatment period ]
    Descriptive analysis of change in A1C from baseline to end of 3-month treatment period


Secondary Outcome Measures :
  1. Age 7-13 Years Old Subjects Mean Change in % of Time in Euglycemia (70-180 mg/dL) [ Time Frame: baseline and 3 months ]
    mean change in % of time in Euglycemia (70-180 mg/dL) from baseline to 3 months treatment period

  2. Age 7-13 Years Old Subjects Mean Change in % of Time in Hyperglycemia (> 180 mg/dL) [ Time Frame: baseline and 3 months ]
    mean change in % of time in hyperglycemia (> 180 mg/dL) from baseline to 3 months treatment period

  3. Age 7-13 Years Old Subjects Mean Change in % of Time in Hypoglycemia (<70 mg/dL) [ Time Frame: baseline and 3 months ]
    mean change in % of time in hypoglycemia (< 70 mg/dL) from baseline to 3 months treatment period

  4. Age 7-13 Years Old - Number of Severe Hypoglycemic Event [ Time Frame: 3 months ]
    Number of severe hypoglycemic events occurred during 3-month treatment period.

  5. Age 7-13 Years Old - Number of Diabetic Ketoacidosis (DKA) Event [ Time Frame: 3 months ]
    Number of Diabetic Ketoacidosis (DKA) events occurred during 3-month treatment period.

  6. Age 7-13 Years Old Subjects PLGM Performance - Event Rate Without Hypoglycemia at YSI-FST <=65 mg/dL [ Time Frame: Up to 12 hours after the start of PLGM period ]
    Event rate without Hypoglycemia at YSI-FST <=65 mg/dL among 105 subjects who underwent the PLGM experiments. The event rate without hypoglycemia is the number of experiments without hypoglycemia/total number of experiments and hypoglycemic events are defined based on the occurrence of 2 or more continuous YSI-FST <= 65mg/dL during in-clinic procedures.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

General Inclusion Criteria

  1. Subject is age 2-13 years at time of screening
  2. Subject has a clinical diagnosis of type 1 diabetes for 1 year or more as determined via medical record or source documentation by an individual qualified to make a medical diagnosis
  3. Subject age 2-6 years has a clinical diagnosis of type 1 diabetes for 3 months or more as determined via medical record or source documentation by an individual qualified to make a medical diagnosis

    Study-specific inclusion criteria

  4. Subject must have a minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units
  5. Subjects 7-13: Subjects and their parent(s)/guardian(s) are willing to participate in an overnight visit at the end of the run-in period.
  6. Subject 7-13 years of age and their parent(s)/guardian(s) are willing to participate in a hotel study for the specified duration of hotel stay.
  7. Subject 2-6 years of age and their parent(s)/guardian(s) are willing to participate in an extended visit during the study period to perform Frequent Sample Testing.
  8. Subject must have companion 18 years or older who will sleep in the same dwelling place every night during the study period. This requirement may be verified by subject report at screening visit.
  9. Subject is willing to perform ≥ 4 finger stick blood glucose measurements daily
  10. Subject is willing to perform required sensor calibrations
  11. Subject is willing to wear the system continuously throughout the study
  12. Subject has a Glycosylated hemoglobin (A1C) value less than 10.0% (as processed by Central Lab) at time of screening visit Note: All HbA1C blood specimens will be sent to and tested by a NGSP certified Central Laboratory. A1C testing must follow National Glycohemoglobin Standardization Program (NGSP) standards.
  13. Subject 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.
  14. Subject 7 -13 years of age has had pump therapy for greater than 6 months prior to screening (with or without CGM experience)
  15. Subject 2-6 years of age has had pump therapy for greater than 90 days prior to screening (with or without CGM experience)
  16. Subjects and their parent(s)/guardian(s) are 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
  17. If subject has celiac disease, it has been adequately treated as determined by the investigator
  18. Subjects and their parent(s)/guardian(s) are 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)
  19. Subjects and their parent(s)/guardian(s)/companions must be able to speak and be literate in English as verified by the investigator

Exclusion Criteria:

  1. Subject has a history of 2 or more episodes of severe hypoglycemia, which resulted in any the following during the 6 months prior to screening:

    1. Medical assistance (i.e. Paramedics, Emergency Room ( ER) or Hospitalization)
    2. Coma
    3. Seizures
  2. Subject is unable to tolerate tape adhesive in the area of sensor placement
  3. Subject 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. Subject has a cardiovascular condition which the investigator determines should exclude the subject, i.e. ventricular rhythm disturbance, hypertrophic cardiomyopathy
  6. Subject is being treated for hyperthyroidism at time of screening
  7. Subject has diagnosis of adrenal insufficiency
  8. Subject 7-13 years of age has had DKA in the 6 months prior to screening visit.
  9. Subject 2-6 years of age has had DKA in the 3 months prior to screening visit
  10. Subject has taken any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV glucocorticoids during the course of the study
  11. Subject is 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
  12. Subject 7-13 years of age has been hospitalized or has visited the ER in the 6 months prior to screening resulting in a primary diagnosis of uncontrolled diabetes
  13. Subject 2-6 years of age has been hospitalized or has visited the ER in the 3 months prior to screening resulting in a primary diagnosis of uncontrolled diabetes
  14. Subject is currently abusing illicit drugs
  15. Subject is currently abusing marijuana.
  16. Subject is currently abusing prescription drugs
  17. Subject is currently abusing alcohol
  18. Subject is using pramlintide (Symlin), DPP-4 inhibitor, liraglutide (Victoza or other GLP-1 agonists), metformin, canagliflozin (Invokana or other SGLT2 inhibitors) at time of screening
  19. Subject 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
  20. Subject has elective surgery planned that requires general anesthesia during the course of the study
  21. Subject has a sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening
  22. Subject plans to receive red blood cell transfusion or erythropoietin over the course of study participation
  23. Subject diagnosed with current eating disorder such as anorexia or bulimia
  24. Subject has been diagnosed with chronic kidney disease that results in chronic anemia
  25. Subject has a hematocrit that is below the normal reference range of lab used.
  26. Subject is on dialysis
  27. Subject has serum creatinine of >2 mg/dL.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02660827


Locations
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United States, California
AMCR Institute
Escondido, California, United States, 92025
Stanford Hospital and Clinics
Palo Alto, California, United States, 94305
SoCal Diabetes
Torrance, California, United States, 90505
United States, Colorado
Barbara Davis Center
Aurora, Colorado, United States, 80045
United States, Florida
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
University of South Florida - USF Health
Tampa, Florida, United States, 33620
United States, Georgia
Atlanta Diabetes Associates
Atlanta, Georgia, United States, 30318
United States, Idaho
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, United States, 83404
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Israel
Sheba Medical Center
Tel Aviv, Israel
Sponsors and Collaborators
Medtronic Diabetes
  Study Documents (Full-Text)

Documents provided by Medtronic Diabetes:
Study Protocol  [PDF] September 14, 2018
Statistical Analysis Plan  [PDF] October 18, 2017


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Medtronic Diabetes
ClinicalTrials.gov Identifier: NCT02660827     History of Changes
Other Study ID Numbers: CEP 302
First Posted: January 21, 2016    Key Record Dates
Results First Posted: January 11, 2019
Last Update Posted: January 11, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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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