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Sponsors and Collaborators: |
Thomas Jefferson University LifeScan Diabetech |
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Information provided by: | Thomas Jefferson University |
ClinicalTrials.gov Identifier: | NCT00297635 |
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.
Condition | Intervention | Phase |
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Diabetes Mellitus, Type 1 Diabetes Mellitus, Insulin-Dependent |
Device: GlucoDYNAMIX™ intervention system Device: GlucoMON™ telemetry device |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Estimated Enrollment: | 32 |
Study Start Date: | March 2006 |
Estimated Study Completion Date: | December 2007 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must reside in the Philadelphia area and participate in regular in person visits to the Jefferson Diabetes Research Center. Patients must be at the stage of their treatment where they are going to initiate insulin infusion pump therapy. Patients must be at least 18 years of age before starting the protocol and must have never used an insulin pump before. Ideally, at least a few of the study participants will use English as a second language. Since the technology is capable of delivering messages to the wireless email device in several languages including Spanish and French, there is no English only requirement. Likewise, patients not capable of operating the wireless email device will be included since the GlucoMON device is specially designed to enable patient use without technology aptitude typical for personal computers and interactive wireless devices.
Exclusion Criteria:
Patients living outside the Philadelphia area and those that are not immediately going to initiate insulin pump therapy wil be excluded. Patients unwilling to perform at least 4 blood glucose self-tests will be ineligible for participation in this study. Conventional guidelines for minimum self-care will apply including criteria for discontinuance of insulin pump therapy.
Contact: Leslie Padron-Massara | 215-955-1978 | Leslie.Padron-Massara@jefferson.edu |
Contact: Cheryl Marco, RD, CDE | 215-955-5078 | Cheryl.Marco@jefferson.edu |
United States, Pennsylvania | |
Division of Endocrinology, Diabetes and Metabolic Diseases; Thomas Jefferson University | |
Philadelphia, Pennsylvania, United States, 19107 |
Principal Investigator: | Barry J. Goldstein, MD, PhD | Thomas Jefferson University |
Study ID Numbers: | 06C.07 |
Study First Received: | February 23, 2006 |
Last Updated: | March 28, 2006 |
ClinicalTrials.gov Identifier: | NCT00297635 |
Health Authority: | United States: Food and Drug Administration |
Hyperglycemia Insulin Infusion Systems Blood Glucose Self-Monitoring |
Autoimmune Diseases Metabolic Diseases Hyperglycemia Diabetes Mellitus, Type 1 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Insulin |
Immune System Diseases |