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

Continuous Glucose Monitoring in Subjects With Type 2 Diabetes

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Rocky Mountain Diabetes and Osteoporosis Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects of all adult ages (18 and older) with type 2 diabetes.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Basal insulin, approved oral medications

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in HgbA1c	Measured at 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of Time Spent at Glycemic Levels <65 mg/dl	Measured at baseline and at 6 months
Change in Percentage of Time Spent at Glycemic Levels >180 mg/dl	Measured at baseline and 6 months
Change in Basal Insulin Dose From Baseline Values	Assessed at baseline and 6 months

Collaborators and Investigators

• Sponsor: Rocky Mountain Diabetes and Osteoporosis Center
• Investigators: Principal Investigator: David R. Liljenquist, MD, Rocky Mountain Diabetes and Osteoporosis Center

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: April 21, 2011
• First Submitted That Met QC Criteria: April 22, 2011
• First Posted (Estimate): April 25, 2011

Study Record Updates

• Last Update Posted (Estimate): May 2, 2014
• Last Update Submitted That Met QC Criteria: April 1, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: RMDC-001