Continuous Glucose Monitoring (CGM) in Subjects With Type 2 Diabetes (DexlonT2)

Rocky Mountain Diabetes and Osteoporosis Center

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Study type: Observational

Funder types: Industry

Identifiers

NCT01341067

RMDC-001

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

30 participants in 1 patient group

Basal insulin, approved oral medications