Threshold Suspend in Pediatrics at Home
Multi-Center, Prospective, Observational Study of the TS (Threshold Suspend) Feature With a Sensor-Augmented Pump System in Pediatric Patients With Type 1 Diabetes
1 other identifier
interventional
194
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2014
Typical duration for not_applicable
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 21, 2014
CompletedFirst Posted
Study publicly available on registry
April 23, 2014
CompletedStudy Start
First participant enrolled
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 16, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 16, 2017
CompletedResults Posted
Study results publicly available
August 15, 2018
CompletedSeptember 11, 2018
August 1, 2018
3 years
April 21, 2014
June 16, 2018
August 15, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Mean Change in A1C
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.
Baseline and 1 year after screening
Secondary Outcomes (3)
Mean Change in A1C From Baseline to 1 Year, Stratified by Different A1c Subgroups
Baseline and 1 year after screening
Mean Change in A1C From Baseline to 1 Year, Stratified by Different A1c Subgroups
Baseline and 1 year after screening
Mean Change in A1C From Baseline to 1 Year, Stratified by Different A1c Subgroups
Baseline and 1 year after screening
Study Arms (1)
530G insulin pump
EXPERIMENTALSubjects will use 530G insulin pump with Threshold Suspend (TS) feature for one year.
Interventions
Subjects will use 530G insulin pump with Threshold Suspend (TS) feature for one year.
Eligibility Criteria
You may qualify if:
- Subject is age 2 to 15 at time of screening
- Subject has been diagnosed with type 1 diabetes mellitus and must have been diagnosed for at least one year prior to screening
- Subject is currently transitioning from pump therapy, with or without continued glucose monitoring (CGM), to the 530G insulin pump system.
- Subject is willing to perform greater than or equal to 4 finger stick blood glucose measurements daily
- Subject is willing to perform required sensor calibrations
- Subject is willing to wear the system (Pump, glucose sensors, meter) continuously throughout the study
- Subject is willing to upload data every 21 days from the study pump
- 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.
- Subject is using either Humalog or Novolog at time of Screening and plans to use either of those insulins throughout the study
You may not qualify if:
- 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.
- Women of child-bearing potential who have a positive pregnancy test at screening or plan to become pregnant during the course of the study
- Subject is being treated for hyperthyroidism at time of screening
- Subject has an abnormality (\>1.8mg/dL) in creatinine at time of screening visit
- 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.
- 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
- Subject is currently abusing illicit drugs
- Subject is currently abusing prescription drugs
- Subject is currently abusing alcohol
- Subject is using pramlintide (Symlin) at time of screening
- Subject has a sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening
- Subject plans to receive red blood cell transfusion or erythropoietin over the course of study participation
- Subject diagnosed with current eating disorder such as anorexia or bulimia
- Subject has been diagnosed with chronic kidney disease that results in chronic anemia
- Subject is on dialysis
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
Children's Hospital of Orange County
Orange, California, 92868, United States
Sutter Institute for Medical Research Excellence in Diabetes and Endocrinology
Sacramento, California, 95821, United States
Madison Clinic for Pediatric Diabetes at UCSF
San Francisco, California, 94158, United States
Stanford University
Stanford, California, 94305, United States
SoCal Diabetes
Torrance, California, 90505, United States
University of Colorado Health Science Center, Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, 80045, United States
Yale University School of Medicine
New Haven, Connecticut, 06519, United States
Nemours Children's Health System
Jacksonville, Florida, 32207, United States
Park Nicollet Clinic - International Diabetes Center
Minneapolis, Minnesota, 55416, United States
University of Minnesota Pediatric Endocrinology Clinic
Minneapolis, Minnesota, 55454, United States
Children's Hospital and Clinics of Minnesota
Saint Paul, Minnesota, 55102, United States
The Pediatric and Endocrine Diabetes Specialists
Las Vegas, Nevada, 89148, United States
Stony Brook Children's Hospital
East Setauket, New York, 11733, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Texas Children Hospital/Baylor College of Medicine
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Suiying Huang, Statistician
- Organization
- Medtronic Minimed
Study Officials
- STUDY DIRECTOR
Scott Lee, M.D.
Medtronic Diabetes
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2014
First Posted
April 23, 2014
Study Start
June 1, 2014
Primary Completion
June 16, 2017
Study Completion
June 16, 2017
Last Updated
September 11, 2018
Results First Posted
August 15, 2018
Record last verified: 2018-08