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出境医 / 临床实验 / Safety Evaluation of the Advanced Hybrid Closed Loop (AHCL) System

Safety Evaluation of the Advanced Hybrid Closed Loop (AHCL) System

Study Description
Brief Summary:
This study is a Safety Evaluation of the Advanced Hybrid Closed Loop (AHCL) System in Type 1 Adult and Pediatric Subjects.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Device: AHCL insulin pump system Not Applicable

Detailed Description:
The purpose of this study is to evaluate the safety of the Advanced Hybrid Closed Loop system (AHCL) in type 1 diabetes adult and pediatric subjects in a home setting. The main objective in conducting this research is to collect data from patients who use the AHCL system at home, at work, at school and everywhere else.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 288 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety Evaluation of the Advanced Hybrid Closed Loop (AHCL) System in Type 1 Adult and Pediatric Subjects
Actual Study Start Date : June 7, 2019
Estimated Primary Completion Date : January 15, 2022
Estimated Study Completion Date : March 1, 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: Subjects 7-75 years of age
Subjects who have been diagnosed with type 1 diabetes
 Device: AHCL insulin pump system
Advanced Hybrid Closed Loop insulin pump with associated CGM and blood glucose meter
Outcome Measures
Primary Outcome Measures :
  1. Change in HbA1c [ Time Frame: 3 months ]
    The overall mean difference of the change in HbA1c from baseline to end of 3-month study period.

  2. Change in percentage of Euglycemia [ Time Frame: 3 months ]
    The overall mean change in % of time in euglycemia (70-180 mg/dL) from baseline to the end of study will be estimated.


Secondary Outcome Measures :
  1. Number of Severe Hypoglycemic Event [ Time Frame: 3 months ]
    Number of severe hypoglycemic events occurred during 3-month period

  2. Number of Diabetic Ketoacidosis (DKA) Event [ Time Frame: 3 months ]
    Number of Diabetic Ketoacidosis (DKA) event occurred during 3-month period


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   7 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is age 7-75 years at time of Screening
  2. Subjects 14-75 years of age: 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. Subjects 7-13 years of age: 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 Study-specific inclusion criteria
  4. Subject is willing to perform ≥ 4 finger stick blood glucose measurements daily
  5. Subject is willing to perform required sensor calibrations
  6. Subject is willing to wear the system continuously throughout the study
  7. Subject must have a minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units
  8. Subject has a Glycosylated hemoglobin (HbA1c) less than 10% (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. HbA1c testing must follow National Glycohemoglobin Standardization Program (NGSP) standards.
  9. 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.
  10. Pump therapy for greater than 6 months prior to screening (with or without CGM experience)
  11. Subject must have a companion or caregiver available at night for the duration of the study period who resides (or will live) in in the same building (or home). A companion or caregiver should also be available during exercise challenges in the same building, home or location (if not at home). This requirement may be verified by subject report at screening visit.
  12. Subject 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
  13. If subject has celiac disease, it has been adequately treated as determined by the investigator

  14. Subject 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)
  15. Subjects 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

  16. Subjects with the 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

    a. 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
  17. Subjects 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

Exclusion Criteria:

  1. Subject has a history of 1 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 has been hospitalized or has visited the ER in the 6 months prior to Screening resulting in a primary diagnosis of uncontrolled diabetes
  3. Subject has had Diabetic Ketoacidosis (DKA) in the 6 months prior to Screening.
  4. Subject has Hypoglycemia Unawareness, as measured by the Gold questionnaire (Gold, MacLeod et al. 1994) at Screening
  5. Subject is unable to tolerate tape adhesive in the area of sensor placement
  6. Subject has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection)
  7. Women of child-bearing potential who have a positive pregnancy test at Screening or plan to become pregnant during the course of the study
  8. 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.
  9. Subject 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
  10. Subject is being treated for hyperthyroidism at time of Screening
  11. Subject has a diagnosis of adrenal insufficiency
  12. Subject has taken any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks from time of Screening, or plans to take any oral, injectable, or IV glucocorticoids during the course of the study
  13. 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
  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.
  28. Research staff involved with the study.
Contacts and Locations

Locations
Show Show 17 study locations
Sponsors and Collaborators
Medtronic Diabetes
Tracking Information
First Submitted Date  ICMJE May 20, 2019
First Posted Date  ICMJE May 22, 2019
Last Update Posted Date April 28, 2021
Actual Study Start Date  ICMJE June 7, 2019
Estimated Primary Completion Date January 15, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
  • Change in HbA1c [ Time Frame: 3 months ]
    The overall mean difference of the change in HbA1c from baseline to end of 3-month study period.
  • Change in percentage of Euglycemia [ Time Frame: 3 months ]
    The overall mean change in % of time in euglycemia (70-180 mg/dL) from baseline to the end of study will be estimated.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
  • Number of Severe Hypoglycemic Event [ Time Frame: 3 months ]
    Number of severe hypoglycemic events occurred during 3-month period
  • Number of Diabetic Ketoacidosis (DKA) Event [ Time Frame: 3 months ]
    Number of Diabetic Ketoacidosis (DKA) event occurred during 3-month period
Original Secondary Outcome Measures  ICMJE Same as current
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 Advanced Hybrid Closed Loop (AHCL) System
Official Title  ICMJE Safety Evaluation of the Advanced Hybrid Closed Loop (AHCL) System in Type 1 Adult and Pediatric Subjects
Brief Summary This study is a Safety Evaluation of the Advanced Hybrid Closed Loop (AHCL) System in Type 1 Adult and Pediatric Subjects.
Detailed Description The purpose of this study is to evaluate the safety of the Advanced Hybrid Closed Loop system (AHCL) in type 1 diabetes adult and pediatric subjects in a home setting. The main objective in conducting this research is to collect data from patients who use the AHCL system at home, at work, at school and everywhere else.
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 Mellitus
Intervention  ICMJE Device: AHCL insulin pump system
Advanced Hybrid Closed Loop insulin pump with associated CGM and blood glucose meter
Study Arms  ICMJE Experimental: Subjects 7-75 years of age
Subjects who have been diagnosed with type 1 diabetes
Intervention: Device: AHCL insulin pump system
Publications * Not Provided

*   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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 10, 2020) 		288
Original Estimated Enrollment  ICMJE
 (submitted: May 20, 2019) 		250
Estimated Study Completion Date  ICMJE March 1, 2022
Estimated Primary Completion Date January 15, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subject is age 7-75 years at time of Screening
  2. Subjects 14-75 years of age: 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. Subjects 7-13 years of age: 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 Study-specific inclusion criteria
  4. Subject is willing to perform ≥ 4 finger stick blood glucose measurements daily
  5. Subject is willing to perform required sensor calibrations
  6. Subject is willing to wear the system continuously throughout the study
  7. Subject must have a minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units
  8. Subject has a Glycosylated hemoglobin (HbA1c) less than 10% (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. HbA1c testing must follow National Glycohemoglobin Standardization Program (NGSP) standards.
  9. 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.
  10. Pump therapy for greater than 6 months prior to screening (with or without CGM experience)
  11. Subject must have a companion or caregiver available at night for the duration of the study period who resides (or will live) in in the same building (or home). A companion or caregiver should also be available during exercise challenges in the same building, home or location (if not at home). This requirement may be verified by subject report at screening visit.
  12. Subject 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
  13. If subject has celiac disease, it has been adequately treated as determined by the investigator

  14. Subject 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)
  15. Subjects 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

  16. Subjects with the 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

    a. 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
  17. Subjects 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

Exclusion Criteria:

  1. Subject has a history of 1 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 has been hospitalized or has visited the ER in the 6 months prior to Screening resulting in a primary diagnosis of uncontrolled diabetes
  3. Subject has had Diabetic Ketoacidosis (DKA) in the 6 months prior to Screening.
  4. Subject has Hypoglycemia Unawareness, as measured by the Gold questionnaire (Gold, MacLeod et al. 1994) at Screening
  5. Subject is unable to tolerate tape adhesive in the area of sensor placement
  6. Subject has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection)
  7. Women of child-bearing potential who have a positive pregnancy test at Screening or plan to become pregnant during the course of the study
  8. 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.
  9. Subject 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
  10. Subject is being treated for hyperthyroidism at time of Screening
  11. Subject has a diagnosis of adrenal insufficiency
  12. Subject has taken any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks from time of Screening, or plans to take any oral, injectable, or IV glucocorticoids during the course of the study
  13. 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
  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.
  28. Research staff involved with the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03959423
Other Study ID Numbers  ICMJE CIP321
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Medtronic Diabetes
Study Sponsor  ICMJE Medtronic Diabetes
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Medtronic Diabetes
Verification Date April 2021

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

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