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Threshold Suspend in Pediatrics at Home

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
530G Insulin pump
Sponsored by
Medtronic Diabetes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Type 1 diabetes, Pediatric, Threshold Suspend, Sensor augmented pump

Eligibility Criteria

2 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Children's Hospital Los Angeles
  • Children's Hospital of Orange County
  • Sutter Institute for Medical Research Excellence in Diabetes and Endocrinology
  • Madison Clinic for Pediatric Diabetes at UCSF
  • Stanford University
  • SoCal Diabetes
  • University of Colorado Health Science Center, Barbara Davis Center for Childhood Diabetes
  • Yale University School of Medicine
  • Nemours Children's Health System
  • Park Nicollet Clinic - International Diabetes Center
  • University of Minnesota Pediatric Endocrinology Clinic
  • Children's Hospital and Clinics of Minnesota
  • The Pediatric and Endocrine Diabetes Specialists
  • Stony Brook Children's Hospital
  • Children's Hospital of Philadelphia
  • Texas Children Hospital/Baylor College of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

530G insulin pump

Arm Description

Subjects will use 530G insulin pump with Threshold Suspend (TS) feature for one year.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Mean Change in A1C From Baseline to 1 Year, Stratified by Different A1c Subgroups
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%
Mean Change in A1C From Baseline to 1 Year, Stratified by Different A1c Subgroups
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%
Mean Change in A1C From Baseline to 1 Year, Stratified by Different A1c Subgroups
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%

Full Information

First Posted
April 21, 2014
Last Updated
August 15, 2018
Sponsor
Medtronic Diabetes
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1. Study Identification

Unique Protocol Identification Number
NCT02120794
Brief Title
Threshold Suspend in Pediatrics at Home
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 Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
June 16, 2017 (Actual)
Study Completion Date
June 16, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Diabetes

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Type 1 diabetes, Pediatric, Threshold Suspend, Sensor augmented pump

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
single group
Masking
None (Open Label)
Allocation
N/A
Enrollment
194 (Actual)

8. Arms, Groups, and Interventions

Arm Title
530G insulin pump
Arm Type
Experimental
Arm Description
Subjects will use 530G insulin pump with Threshold Suspend (TS) feature for one year.
Intervention Type
Device
Intervention Name(s)
530G Insulin pump
Intervention Description
Subjects will use 530G insulin pump with Threshold Suspend (TS) feature for one year.
Primary Outcome Measure Information:
Title
Overall Mean Change in A1C
Description
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.
Time Frame
Baseline and 1 year after screening
Secondary Outcome Measure Information:
Title
Mean Change in A1C From Baseline to 1 Year, Stratified by Different A1c Subgroups
Description
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%
Time Frame
Baseline and 1 year after screening
Title
Mean Change in A1C From Baseline to 1 Year, Stratified by Different A1c Subgroups
Description
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%
Time Frame
Baseline and 1 year after screening
Title
Mean Change in A1C From Baseline to 1 Year, Stratified by Different A1c Subgroups
Description
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%
Time Frame
Baseline and 1 year after screening

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 Subject is already on a 530G system with CGM for 8 days or more.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Lee, M.D.
Organizational Affiliation
Medtronic Diabetes
Official's Role
Study Director
Facility Information:
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Children's Hospital of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Sutter Institute for Medical Research Excellence in Diabetes and Endocrinology
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Facility Name
Madison Clinic for Pediatric Diabetes at UCSF
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
SoCal Diabetes
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
University of Colorado Health Science Center, Barbara Davis Center for Childhood Diabetes
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Nemours Children's Health System
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Park Nicollet Clinic - International Diabetes Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
University of Minnesota Pediatric Endocrinology Clinic
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
Facility Name
Children's Hospital and Clinics of Minnesota
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
The Pediatric and Endocrine Diabetes Specialists
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Stony Brook Children's Hospital
City
East Setauket
State/Province
New York
ZIP/Postal Code
11733
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Texas Children Hospital/Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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Threshold Suspend in Pediatrics at Home

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