Continuous Glucose Monitoring in Subjects With Type 2 Diabetes

Rocky Mountain Diabetes and Osteoporosis Center1 site in 1 country30 target enrollmentApril 2011

ConditionsType 2 Diabetes Mellitus

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Type 2 Diabetes Mellitus
Sponsor: Rocky Mountain Diabetes and Osteoporosis Center
Enrollment: 30
Locations: 1
Primary Endpoint: Change in HgbA1c
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to examine the effect CGM (continuous glucose monitoring) has on subjects with type 2 diabetes. It is anticipated that patients using the device will obtain tighter control of their blood sugars resulting in measureable health benefits and improved confidence in their ability to manage their diabetes.

Registry

clinicaltrials.gov

Start Date

April 2011

End Date

December 2011

Last Updated

12 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Rocky Mountain Diabetes and Osteoporosis Center

Responsible Party

Principal Investigator

David Liljenquist, M.D.

Primary Investigator

Rocky Mountain Diabetes and Osteoporosis Center

Eligibility Criteria

Inclusion Criteria

•Have been diagnosed with type 2 diabetes mellitus
•Have an HgbA1c value ≥ 7% and ≤17%.
•Are on basal insulin, with or without oral agents
•Are not on basal bolus insulin therapy.
•Have had no severe hypoglycemic episodes in the 6 months prior to enrollment in the study. Severe hypoglycemia will be defined as any hypoglycemia that is both neurologically impairing and absolutely requires assistance from a third party in the form of carbohydrates, glucagon shots, or attention from a paramedic or other healthcare professional.
•Have no known allergy to medical tape or sensors.
•Are capable of and willing to test their blood glucose (BG) on an average of 4 times per day.
•Are willing to not use Acetaminophen while enrolled in the study.
•Are willing not to undergo a MRI procedure while wearing the CGM sensor.
•Are willing and capable of performing self insertions of the device sensor.

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Change in HgbA1c

Time Frame: Measured at 6 months

Secondary Outcomes

Change in Percentage of Time Spent at Glycemic Levels >180 mg/dl(Measured at baseline and 6 months)
Change in Basal Insulin Dose From Baseline Values(Assessed at baseline and 6 months)
Percentage of Time Spent at Glycemic Levels <65 mg/dl(Measured at baseline and at 6 months)