Telemetric Glucose Data Acquisition During Initiation of Insulin Pump Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00297635
Recruitment Status : Withdrawn (Decided not to participate in study per Leslie Padron-Massaro)
First Posted : February 28, 2006
Last Update Posted : January 12, 2017
Information provided by:
Thomas Jefferson University

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Diabetes Mellitus, Insulin-Dependent Device: GlucoDYNAMIX™ intervention system Device: GlucoMON™ telemetry device Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : March 2006
Estimated Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Primary Outcome Measures :
  1. 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
  2. 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 :
  1. Frequency of severe hypoglycemia and extended hyperglycemia.
  2. 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.
  3. Whether use of the technology results in perceived improvement in the quality of care and improved satisfaction for all involved

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00297635

Sponsors and Collaborators
Thomas Jefferson University
Principal Investigator: Barry J. Goldstein, MD, PhD Thomas Jefferson University Identifier: NCT00297635     History of Changes
Other Study ID Numbers: 06C.07
First Posted: February 28, 2006    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: January 2017

Keywords provided by Thomas Jefferson University:
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