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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Walter Reed Army Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:
NCT00529815
First received: September 13, 2007
Last updated: February 24, 2010
Last verified: June 2009
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus Type 2
Device: Continuous Glucose Monitor
Device: Glucometer
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Pilot Study to Determine the Impact of Real-Time Continuous Glucose Monitoring (CGM) on Patients With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Walter Reed Army Medical Center:

Primary Outcome Measures:
  • 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. [ Time Frame: March 1, 2010 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. [ Time Frame: March 1, 2010 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: September 2007
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00529815

Locations
United States, District of Columbia
Walter Reed Army Hospital Center
Washington DC, District of Columbia, United States, 20307
Sponsors and Collaborators
Walter Reed Army Medical Center
Investigators
Principal Investigator: Robert A Vigersky, MD WRAMC
  More Information

No publications provided

Responsible Party: Col. Robert A. Vigersky MC, MD, WRAMC
ClinicalTrials.gov Identifier: NCT00529815     History of Changes
Other Study ID Numbers: WU # 07-13023
Study First Received: September 13, 2007
Last Updated: February 24, 2010
Health Authority: United States: Food and Drug Administration
United States: Federal Government

Keywords provided by Walter Reed Army Medical Center:
Continuous
blood
glucose
monitoring
diabetes
type2

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 01, 2014