Continuous Glucose Monitoring (CGM) in Subjects With Type 2 Diabetes (DexlonT2)
This study has been completed.
Information provided by (Responsible Party):
David Liljenquist, M.D., Rocky Mountain Diabetes and Osteoporosis Center
First received: April 21, 2011
Last updated: April 1, 2014
Last verified: April 2014
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.
||Observational Model: Cohort
Time Perspective: Prospective
||Continuous Glucose Monitoring in Subjects With Type 2 Diabetes
Primary Outcome Measures:
- Change in HgbA1c [ Time Frame: Measured at 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Percentage of Time Spent at Glycemic Levels <65 mg/dl [ Time Frame: Measured at baseline and at 6 months ] [ Designated as safety issue: No ]
- Change in Percentage of Time Spent at Glycemic Levels >180 mg/dl [ Time Frame: Measured at baseline and 6 months ] [ Designated as safety issue: No ]
- Change in Basal Insulin Dose From Baseline Values [ Time Frame: Assessed at baseline and 6 months ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||December 2011 (Final data collection date for primary outcome measure)
Basal insulin, approved oral medications
|Ages Eligible for Study:
||18 Years and older
|Genders 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.
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: NCT01341067
|Rocky Mountain Diabetes and Osteoporosis Center
|Idaho Falls, Idaho, United States, 83404 |
Rocky Mountain Diabetes and Osteoporosis Center
||David R. Liljenquist, MD
||Rocky Mountain Diabetes and Osteoporosis Center
No publications provided
||David Liljenquist, M.D., Primary Investigator, Rocky Mountain Diabetes and Osteoporosis Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 21, 2011
|Results First Received:
||March 22, 2013
||April 1, 2014
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 27, 2014
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders