Telemetric Glucose Data Acquisition During Initiation of Insulin Pump Therapy

NCT00297635 | Withdrawn Phase 2

• 1 other identifier: 06C.07
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Insulin-Dependent

Keywords

Hyperglycemia; Insulin Infusion Systems; Blood Glucose Self-Monitoring

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Interventions

GlucoDYNAMIX™ intervention system DEVICE

GlucoMON™ telemetry device DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Thomas Jefferson University: lead
• LifeScan: collaborator
• Diabetech: collaborator

Related Links

• TJU Division of Endocrinology, Diabetes and Metabolic Diseases
• TJU Diabetes Research Center

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hyperglycemia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Barry J. Goldstein, MD, PhD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 23, 2006
• First Posted: February 28, 2006
• Study Start: March 1, 2006
• Study Completion: December 1, 2007
• Last Updated: January 12, 2017

Record last verified: 2017-01