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

Type 2 Diabetes Mellitus Clinical Trial

— DexlonT2  

Official title:

Continuous Glucose Monitoring in Subjects With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01341067
• Other study ID #: RMDC-001
• Status: Completed
• Phase: N/A
• First received: April 21, 2011
• Last updated: April 1, 2014
• Start date: April 2011
• Est. completion date: December 2011

Study information

• Verified date: April 2014
• Source: Rocky Mountain Diabetes and Osteoporosis Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Locations

Country	Name	City	State
United States	Rocky Mountain Diabetes and Osteoporosis Center	Idaho Falls	Idaho

Sponsors (1)

Lead Sponsor	Collaborator
Rocky Mountain Diabetes and Osteoporosis Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HgbA1c		Measured at 6 months	No
Secondary	Percentage of Time Spent at Glycemic Levels <65 mg/dl		Measured at baseline and at 6 months	No
Secondary	Change in Percentage of Time Spent at Glycemic Levels >180 mg/dl		Measured at baseline and 6 months	No
Secondary	Change in Basal Insulin Dose From Baseline Values		Assessed at baseline and 6 months	No