Continuous Glucose Monitoring in Patients With Type 2 Diabetes

NCT ID: NCT00529815

Last Updated: 2010-02-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2010-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1CGM and SBGM

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.

Group Type: EXPERIMENTAL

Continuous Glucose Monitor

Intervention Type: DEVICE

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.

2 SBGM

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

Group Type: ACTIVE_COMPARATOR

Glucometer

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Glucometer

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age 18 or older.

2. Known Type 2 diabetes for at least 3 months

3. Diet controlled, on oral therapy, on basal insulin (e.g. glargine), or on oral therapy and a basal insulin

4. A1C levels between 7% and 12%.

5. Able to independently measure and read finger stick blood glucose levels with the Accu-chek Aviva glucometer and the DexCom Continuous Glucose Monitoring device (DexCom DTS-7).

6. Subjects will have attended a American Diabetes Association recognized Diabetes Self-Management Education (DSME) program at one of the WRHCS military treatment facilities (MTFs) within the past five years.

7. Willing to avoid or minimize use of acetaminophen (Tylenol) and all acetaminophen- containing products such as most over-the-counter (OTC) medications during the study period (Appendix 5)..

Exclusion Criteria

1. Female subjects who are pregnant, lactating, planning to become pregnant, or without a safe contraceptive method.

2. A1C levels are less than 7 or greater than 12.

3. Subjects who are taking glucocorticoids, amphetamines, anabolic, or weight-reducing agents during the course of the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Walter Reed Army Medical Center

FED

Sponsor Role: lead

Responsible Party

WRAMC

Principal Investigators

Robert A Vigersky, MD

Role: PRINCIPAL_INVESTIGATOR

WRAMC

Locations

Walter Reed Army Hospital Center

Washington D.C., District of Columbia, United States

Countries

United States

Other Identifiers

WU # 07-13023

Identifier Type: -

Identifier Source: org_study_id