Threshold Suspend in Pediatrics at Home

Type 1 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02120794
• Other study ID #: CEP287
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: June 16, 2017

Study information

• Verified date: August 2018
• Source: Medtronic Diabetes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: June 16, 2017
• Est. primary completion date: June 16, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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

Locations

Country	Name	City	State
United States	University of Colorado Health Science Center, Barbara Davis Center for Childhood Diabetes	Aurora	Colorado
United States	Stony Brook Children's Hospital	East Setauket	New York
United States	Texas Children Hospital/Baylor College of Medicine	Houston	Texas
United States	Nemours Children's Health System	Jacksonville	Florida
United States	The Pediatric and Endocrine Diabetes Specialists	Las Vegas	Nevada
United States	Children's Hospital Los Angeles	Los Angeles	California
United States	Park Nicollet Clinic - International Diabetes Center	Minneapolis	Minnesota
United States	University of Minnesota Pediatric Endocrinology Clinic	Minneapolis	Minnesota
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Children's Hospital of Orange County	Orange	California
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Sutter Institute for Medical Research Excellence in Diabetes and Endocrinology	Sacramento	California
United States	Children's Hospital and Clinics of Minnesota	Saint Paul	Minnesota
United States	Madison Clinic for Pediatric Diabetes at UCSF	San Francisco	California
United States	Stanford University	Stanford	California
United States	SoCal Diabetes	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Diabetes

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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%	Baseline and 1 year after screening
Secondary	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%	Baseline and 1 year after screening
Secondary	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%	Baseline and 1 year after screening