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Continuous Glucose Monitoring in Patients With Type 2 Diabetes

NCT00529815 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2010-02-25

No results posted yet for this study

Summary

The purpose of this pilot study is to determine if a Real-Time Continuous Glucose Monitoring System (CGMS) is a more effective method of improving glycemic control in patients with type 2 diabetes than is episodic self blood glucose monitoring(SBGM) in the both the short- and long-term. CGMS, which includes a sensor that can be self- inserted under the skin and a discrete monitor that records and displays blood sugar levels nearly continuously, allows for real time blood glucose monitoring. This will be a prospective, randomized control trial comparing participants with type II diabetes use of CGMS versus SBGM. The primary endpoint will be improvement of glycemic control as measured by glycosylated hemoglobin (A1C). The secondary endpoints will compare mean daily glucose levels, the number of both hypoglycemic and hyperglycemic events, the amount of time spent in target blood glucose, and the perceived level of diabetes-related stress between the two groups. Participants will be randomized to either the control (SBGM) or intervention (CGMS) group. Subjects in the intervention group will alternate the use of the CGMS with episodic self blood glucose monitoring for four cycles of two weeks during the 12 week study. The control group will perform episodic SBGM throughout the study. The intensified monitoring schedules for both groups will end at the end of week 12, but glycemic control measurement by A1C will continue through 52 weeks. A1C levels will be drawn at 0, 12, 24, 38, and 52 weeks. Mean daily blood glucose levels, number of hypo and hyperglycemic events, and duration of time spent in target blood glucose range will be downloaded from patients' meters periodically throughout the study. The SF-8, a general quality of life questionnaire for people with chronic disease, and Problem Areas in Diabetes (PAID), a diabetes-related quality of life questionnaire, will be completed at the beginning and end of the study. The results of this study may help highlight which blood glucose monitoring methods are most likely to improve patients' ability to achieve and maintain target levels of glycemic control.

Conditions

  • Diabetes Mellitus Type 2

Interventions

DEVICE

Continuous Glucose Monitor

The intervention group will alternate the use of the CGM with episodic self blood glucose monitoring for four cycles of two weeks using the CGM and episodic SBGM and one week only using episodic SBGM during the 12 week study.

DEVICE

Glucometer

The control group (SBGM) will be instructed in the use of the Accuchek Aviva glucometer.

Sponsors & Collaborators

  • Walter Reed Army Medical Center

    lead FED

Principal Investigators

  • Robert A Vigersky, MD · WRAMC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2010-03-31
Completion
2010-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00529815 on ClinicalTrials.gov