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

NCT ID: NCT01341067

Last Updated: 2014-05-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2011-12-31

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Basal insulin, approved oral medications

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rocky Mountain Diabetes and Osteoporosis Center

INDUSTRY

Sponsor Role: lead

Responsible Party

David Liljenquist, M.D.

Primary Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David R. Liljenquist, MD

Role: PRINCIPAL_INVESTIGATOR

Rocky Mountain Diabetes and Osteoporosis Center

Locations

Rocky Mountain Diabetes and Osteoporosis Center

Idaho Falls, Idaho, United States

Countries

United States

Other Identifiers

RMDC-001

Identifier Type: -

Identifier Source: org_study_id