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Threshold Suspend in Pediatrics at Home

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: NCT02120794
Recruitment Status : Completed
First Posted : April 23, 2014
Results First Posted : August 15, 2018
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic Diabetes

Brief Summary:
The study objective is to demonstrate that home use of Threshold Suspend (TS) is not associated with glycemic deterioration in pediatric patients with type 1 diabetes, as measured by change in A1C.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Device: 530G Insulin pump Not Applicable

Detailed Description:
This study is a longitudinal, multi-center trial that aims to observe the Threshold Suspend (TS) feature with a sensor-augmented insulin pump in patients 7-15 years with Type 1 diabetes. The study will measure the change in A1C from baseline over a period of one year while subjects are wearing the study pump.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 194 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: single group
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multi-Center, Prospective, Observational Study of the TS (Threshold Suspend) Feature With a Sensor-Augmented Pump System in Pediatric Patients With Type 1 Diabetes
Study Start Date : June 2014
Actual Primary Completion Date : June 16, 2017
Actual Study Completion Date : June 16, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: 530G insulin pump
Subjects will use 530G insulin pump with Threshold Suspend (TS) feature for one year.
Device: 530G Insulin pump
Subjects will use 530G insulin pump with Threshold Suspend (TS) feature for one year.




Primary Outcome Measures :
  1. Overall Mean Change in A1C [ Time Frame: Baseline and 1 year after screening ]
    The overall mean change in A1C from baseline to 1 year will be estimated and compared by a non-inferiority test with an A1C margin of 0.4% and a significance level of 0.025 (one-sided). Among the 136 subjects who completed the study, 132 had both baseline and end of study A1c. Therefore, primary endpoint was based on 132 subjects.


Secondary Outcome Measures :
  1. Mean Change in A1C From Baseline to 1 Year, Stratified by Different A1c Subgroups [ Time Frame: Baseline and 1 year after screening ]
    Mean change in A1C from baseline to 1 year, stratified by different A1c subgroups: A1c below 7%. Among the 132 subjects with both baseline and end of study A1c, 3 had A1c below 7%

  2. Mean Change in A1C From Baseline to 1 Year, Stratified by Different A1c Subgroups [ Time Frame: Baseline and 1 year after screening ]
    Mean change in A1C from baseline to 1 year, stratified by different A1c subgroups: A1c 7% to 9%. Among the 132 subjects with both baseline and end of study A1c, 97 had A1c 7% to 9%

  3. Mean Change in A1C From Baseline to 1 Year, Stratified by Different A1c Subgroups [ Time Frame: Baseline and 1 year after screening ]
    Mean change in A1C from baseline to 1 year, stratified by different A1c subgroups: A1c > 9%. Among the 132 subjects with both baseline and end of study A1c, 32 had A1c > 9%



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Ages Eligible for Study:   2 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is age 2 to 15 at time of screening
  2. Subject has been diagnosed with type 1 diabetes mellitus and must have been diagnosed for at least one year prior to screening
  3. Subject is currently transitioning from pump therapy, with or without continued glucose monitoring (CGM), to the 530G insulin pump system.
  4. Subject is willing to perform greater than or equal to 4 finger stick blood glucose measurements daily
  5. Subject is willing to perform required sensor calibrations
  6. Subject is willing to wear the system (Pump, glucose sensors, meter) continuously throughout the study
  7. Subject is willing to upload data every 21 days from the study pump
  8. Subject must have Internet access and access to a computer system that meets the requirements for uploading the pumps. This may include use of family or friend's computer system with Internet access.
  9. Subject is using either Humalog or Novolog at time of Screening and plans to use either of those insulins throughout the study

Exclusion Criteria:

  1. Subject is actively participating in an investigational study (drug or device) wherein he/she is receiving treatment from an investigational study drug or investigational study device.
  2. Women of child-bearing potential who have a positive pregnancy test at screening or plan to become pregnant during the course of the study
  3. Subject is being treated for hyperthyroidism at time of screening
  4. Subject has an abnormality (>1.8mg/dL) in creatinine at time of screening visit
  5. Subject has an abnormality (out of reference range) in thyroid-stimulating hormone (TSH) at time of screening visit; If TSH is out of range, Free T3 and Free T4 will be tested; subject may be included with TSH out of range as long as Free T3 and Free T4 are in normal reference range.
  6. Subject has taken any oral, injectable, or 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
  7. Subject is currently abusing illicit drugs
  8. Subject is currently abusing prescription drugs
  9. Subject is currently abusing alcohol
  10. Subject is using pramlintide (Symlin) at time of screening
  11. Subject has a sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening
  12. Subject plans to receive red blood cell transfusion or erythropoietin over the course of study participation
  13. Subject diagnosed with current eating disorder such as anorexia or bulimia
  14. Subject has been diagnosed with chronic kidney disease that results in chronic anemia
  15. Subject is on dialysis
  16. Subject is already on a 530G system with CGM for 8 days or more.

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): NCT02120794


Locations
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United States, California
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Children's Hospital of Orange County
Orange, California, United States, 92868
Sutter Institute for Medical Research Excellence in Diabetes and Endocrinology
Sacramento, California, United States, 95821
Madison Clinic for Pediatric Diabetes at UCSF
San Francisco, California, United States, 94158
Stanford University
Stanford, California, United States, 94305
SoCal Diabetes
Torrance, California, United States, 90505
United States, Colorado
University of Colorado Health Science Center, Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States, 80045
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06519
United States, Florida
Nemours Children's Health System
Jacksonville, Florida, United States, 32207
United States, Minnesota
Park Nicollet Clinic - International Diabetes Center
Minneapolis, Minnesota, United States, 55416
University of Minnesota Pediatric Endocrinology Clinic
Minneapolis, Minnesota, United States, 55454
Children's Hospital and Clinics of Minnesota
Saint Paul, Minnesota, United States, 55102
United States, Nevada
The Pediatric and Endocrine Diabetes Specialists
Las Vegas, Nevada, United States, 89148
United States, New York
Stony Brook Children's Hospital
East Setauket, New York, United States, 11733
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Texas Children Hospital/Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Medtronic Diabetes
Investigators
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Study Director: Scott Lee, M.D. Medtronic Diabetes
  Study Documents (Full-Text)

Documents provided by Medtronic Diabetes:
Study Protocol  [PDF] August 17, 2015
Statistical Analysis Plan  [PDF] February 6, 2015

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Responsible Party: Medtronic Diabetes
ClinicalTrials.gov Identifier: NCT02120794    
Other Study ID Numbers: CEP287
First Posted: April 23, 2014    Key Record Dates
Results First Posted: August 15, 2018
Last Update Posted: September 11, 2018
Last Verified: August 2018
Keywords provided by Medtronic Diabetes:
Type 1 diabetes
Pediatric
Threshold Suspend
Sensor augmented pump
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs