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Telemetric Glucose Data Acquisition During Initiation of Insulin Pump Therapy

This study has been withdrawn prior to enrollment.
(Decided not to participate in study per Leslie Padron-Massaro)
Sponsor:
Collaborators:
LifeScan
Diabetech
Information provided by:
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00297635
First received: February 23, 2006
Last updated: March 18, 2011
Last verified: March 2011
History of Changes
  Purpose

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
Diabetes Mellitus, Type 1
Diabetes Mellitus, Insulin-Dependent
 Device: GlucoDYNAMIX™ intervention system
Device: GlucoMON™ telemetry device
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 32
Study Start Date: March 2006
Estimated Study Completion Date: December 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00297635

Sponsors and Collaborators
Thomas Jefferson University
LifeScan
Diabetech
Investigators
Principal Investigator: Barry J. Goldstein, MD, PhD Thomas Jefferson University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00297635     History of Changes
Other Study ID Numbers: 06C.07
Study First Received: February 23, 2006
Last Updated: March 18, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Thomas Jefferson University:
Hyperglycemia
Insulin Infusion Systems
Blood Glucose Self-Monitoring

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013