Telemetric Glucose Data Acquisition During Initiation of Insulin Pump Therapy
This study will help determine whether the use of a wireless glucose meter and and an internet-based automated diabetes management system to organize blood glucose values will help improve glucose control during the start of continuous subcutaneous insulin infusion therapy by an insulin pump device in patients with type 1 diabetes. Outcome measures to be determined include an assessment of glucose excursions, overall glucose control, health care team staff and patient time required and a satisfaction survey.
Diabetes Mellitus, Type 1
Diabetes Mellitus, Insulin-Dependent
Device: GlucoDYNAMIX™ intervention system
Device: GlucoMON™ telemetry device
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
- Regulation of blood glucose excursions, measured by hemoglobin A1c at the end of the 3 month study period and again after an additional 3 month follow-up period
- Magnitude of glucose excursions and fluctuations as indicated by the standard deviation between glucose tests to indicate relative glucose control and the mean daily glucose value over the 3 month period following the initiation of pump therapy
- Frequency of severe hypoglycemia and extended hyperglycemia.
- Saving of staff time in support of data collection, analysis and patient feedback including delivery and follow-up to monitor effects on glucose control from patient implementation of prescribed changes.
- Whether use of the technology results in perceived improvement in the quality of care and improved satisfaction for all involved
|Study Start Date:||March 2006|
|Estimated Study Completion Date:||December 2007|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00297635
|Principal Investigator:||Barry J. Goldstein, MD, PhD||Thomas Jefferson University|