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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02660827
Recruitment Status : Completed
First Posted : January 21, 2016
Results First Posted : January 11, 2019
Last Update Posted : January 26, 2022
Sponsor:
Information provided by (Responsible Party):
Medtronic Diabetes

Tracking Information
First Submitted Date  ICMJE January 16, 2016
First Posted Date  ICMJE January 21, 2016
Results First Submitted Date  ICMJE October 22, 2018
Results First Posted Date  ICMJE January 11, 2019
Last Update Posted Date January 26, 2022
Actual Study Start Date  ICMJE April 18, 2016
Actual Primary Completion Date November 28, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2021)
Age 2-13 Years Old Subjects Change in A1C [ Time Frame: Baseline and end of 3-month study period ]
Descriptive analysis of change in A1C from baseline to end of 3-month study period
Original Primary Outcome Measures  ICMJE
 (submitted: January 16, 2016)
Reduction in A1C [ Time Frame: 1 year ]
There is no statistically powered primary endpoint in this study. However, there will be a descriptive analysis of reduction in A1C.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2021)
  • Age 2-13 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 study period
  • Age 2-13 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 study period
  • Age 2-13 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 study period
  • Age 2-13 Years Old - Number of Severe Hypoglycemic Event [ Time Frame: 3 months ]
    Number of severe hypoglycemic events occurred during 3-month study period.
  • Age 2-13 Years Old - Number of Diabetic Ketoacidosis (DKA) Event [ Time Frame: 3 months ]
    Number of Diabetic Ketoacidosis (DKA) events occurred during 3-month study period.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 16, 2016)
  • Event rate of Severe Hypoglycemia [ Time Frame: 1 year ]
    There is no statistically powered secondary endpoint in this study. However, there will be a descriptive analysis of the event rate of Severe Hypoglycemia.
  • Event rate of Diabetic Ketoacidosis (DKA) [ Time Frame: 1 year ]
    There is no statistically powered secondary endpoint in this study. However, there will be a descriptive analysis of the event rate of DKA.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Evaluation of the Hybrid Closed Loop (HCL) System in Pediatric Subjects With Type 1 Diabetes
Official Title  ICMJE Safety Evaluation of the Hybrid Closed Loop (HCL) System in Pediatric Subjects With Type 1 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.
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 up to 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 1 Diabetes
Intervention  ICMJE Device: Insulin Pump
Closed Loop Algorithm
Other Name: MMT-670G
Study Arms  ICMJE Experimental: Hybrid closed loop
All subjects will be wearing the MMT-670G insulin pump, using it with the closed loop algorithm
Intervention: Device: Insulin Pump
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 15, 2020)
151
Original Estimated Enrollment  ICMJE
 (submitted: January 16, 2016)
120
Actual Study Completion Date  ICMJE February 1, 2021
Actual Primary Completion Date November 28, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 13 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02660827
Other Study ID Numbers  ICMJE CEP 302
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Medtronic Diabetes
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Medtronic Diabetes
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Medtronic Diabetes
Verification Date January 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP