Threshold Suspend in Pediatrics at Home

August 15, 2018 updated by: Medtronic Diabetes

Multi-Center, Prospective, Observational Study of the TS (Threshold Suspend) Feature With a Sensor-Augmented Pump System in Pediatric Patients With Type 1 Diabetes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

194

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 1 year after screening

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%
Baseline and 1 year after screening
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%
Baseline and 1 year after screening
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%
Baseline and 1 year after screening

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Diabetes

Investigators

  • Study Director: Scott Lee, M.D., Medtronic Diabetes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

June 16, 2017

Study Completion (Actual)

June 16, 2017

Study Registration Dates

First Submitted

April 21, 2014

First Submitted That Met QC Criteria

April 21, 2014

First Posted (Estimate)

April 23, 2014

Study Record Updates

Last Update Posted (Actual)

September 11, 2018

Last Update Submitted That Met QC Criteria

August 15, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEP287

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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