Continuous Glucose Monitoring in Patients With Type 2 Diabetes (CGM)

A Pilot Study to Determine the Impact of Real-Time Continuous Glucose Monitoring (CGM) on Patients With Type 2 Diabetes

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.

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus Type 2
• Intervention / Treatment: Device: Continuous Glucose Monitor; Device: Glucometer

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington DC, District of Columbia, United States, 20307
      • Walter Reed Army Hospital Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: 2 SBGM; The control group (SBGM) will be instructed in the use of the Accuchek Aviva glucometer.	Device: Glucometer; The control group (SBGM) will be instructed in the use of the Accuchek Aviva glucometer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
This study will determine if a real-time continuous glucose monitoring system is a more effective method of improving glycemic control in patients with type 2 diabetes than is episodic self blood glucose monitoring in the both the short- and long-term.	March 1, 2010

Secondary Outcome Measures

Outcome Measure	Time Frame
The results of this study could also provide information on the impact of the two methods of glycemic monitoring on number of hypoglycemic and hyperglycemic events, and quality of life.	March 1, 2010

Collaborators and Investigators

• Sponsor: Walter Reed Army Medical Center
• Investigators: Principal Investigator: Robert A Vigersky, MD, WRAMC

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Anticipated): March 1, 2010
• Study Completion (Anticipated): September 1, 2010

Study Registration Dates

• First Submitted: September 13, 2007
• First Submitted That Met QC Criteria: September 13, 2007
• First Posted (Estimate): September 14, 2007

Study Record Updates

• Last Update Posted (Estimate): February 25, 2010
• Last Update Submitted That Met QC Criteria: February 24, 2010
• Last Verified: June 1, 2009

More Information

Terms related to this study

• Keywords: diabetes; blood; glucose; monitoring; Continuous; type2
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: WU # 07-13023