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Continuous Glucose Monitoring (CGM) in Subjects With Type 2 Diabetes (DexlonT2)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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ClinicalTrials.gov Identifier: NCT01341067
: April 25, 2011
Results First Posted
: May 2, 2014
Last Update Posted
: May 2, 2014
Rocky Mountain Diabetes and Osteoporosis Center
Information provided by (Responsible Party):
David Liljenquist, M.D., Rocky Mountain Diabetes and Osteoporosis Center
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.
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, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Subjects of all adult ages (18 and older) with type 2 diabetes.
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.
Women of child bearing potential must be willing to use an approved form of birth control while enrolled in the study.
Women of child bearing potential must be willing to perform pregnancy tests monthly while enrolled in the study.
Can understand and speak English fluently.
Have been on pump therapy in the 6 months prior to enrollment in the study.
Are receiving basal- bolus insulin therapy
Are taking any medication that is not approved to be taken with insulin.
Are pregnant or have intentions of becoming pregnant during the duration of the study.
Have any skin condition that would inhibit the proper wearing of the CGM sensor including severe psoriasis, burns, eczema, scarring, excessive tattoos, etc.
Have a hematocrit ≤30% or ≥55%
Are currently enrolled in another clinical study (subjects must have ended participation in other studies at least 30 days prior to enrolling in this study.
Are employed by any company that manufactures or is developing a CGM device.
Are deemed incapable of participating in the study by the Primary Investigator for any reason.