Clinical trial NCT01341067: Continuous Glucose Monitoring (CGM) in Subjects With Type 2 Diabetes
Official title: Continuous Glucose Monitoring in Subjects With Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Rocky Mountain Diabetes and Osteoporosis Center
Sponsor class: INDUSTRY
First posted: 2011-04-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects of all adult ages (18 and older) with type 2 diabetes.

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.


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.
* 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.

Exclusion Criteria

* 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.

Primary outcomes:
measure: Change in HgbA1c
timeFrame: Measured at 6 months
Secondary outcomes:
measure: Percentage of Time Spent at Glycemic Levels <65 mg/dl
timeFrame: Measured at baseline and at 6 months
measure: Change in Percentage of Time Spent at Glycemic Levels >180 mg/dl
timeFrame: Measured at baseline and 6 months
measure: Change in Basal Insulin Dose From Baseline Values
timeFrame: Assessed at baseline and 6 months
Other outcomes:
Locations:
city: Idaho Falls
country: United States
facility: Rocky Mountain Diabetes and Osteoporosis Center
state: Idaho
Study officials:
affiliation: Rocky Mountain Diabetes and Osteoporosis Center
name: David R. Liljenquist, MD
role: PRINCIPAL_INVESTIGATOR
References: