N/A
N=194
Threshold Suspend in Pediatrics at Home
Type 1 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT02120794 ↗Enrolled (actual)
194
Serious AEs
2.1%
Results posted
Aug 2018
Primary outcome: Primary: Overall Mean Change in A1C — 0.26 percentage
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 530G Insulin pump (Device)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Medtronic MiniMed, Inc.
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Mean Change in A1C |
0.26 | — |
| SECONDARY Mean Change in A1C From Baseline to 1 Year, Stratified by Different A1c Subgroups |
-0.02 | — |
| SECONDARY Mean Change in A1C From Baseline to 1 Year, Stratified by Different A1c Subgroups |
-0.02 | — |
| SECONDARY Mean Change in A1C From Baseline to 1 Year, Stratified by Different A1c Subgroups |
-0.02 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02120794). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.