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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David Liljenquist, M.D., Rocky Mountain Diabetes and Osteoporosis Center
ClinicalTrials.gov Identifier:
NCT01341067
First received: April 21, 2011
Last updated: March 12, 2013
Last verified: March 2013
  Purpose

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.


Condition
Type 2 Diabetes Mellitus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Continuous Glucose Monitoring in Subjects With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Rocky Mountain Diabetes and Osteoporosis Center:

Primary Outcome Measures:
  • Change in HgbA1c [ Time Frame: Measured at baseline, 3 months, and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The occurrence of hypoglycemia [ Time Frame: Measured at baseline, 3 months and 6 months. ] [ Designated as safety issue: No ]
  • Occurence of hyperglycemia [ Time Frame: Measured at baseline, 3 months, and 6 months ] [ Designated as safety issue: No ]
  • Glucose variability [ Time Frame: Measured at baseline, 3 months, and 6 months ] [ Designated as safety issue: No ]
  • Percentage of subjects who progressed to basal/bolus treatment due to gathered CGM data [ Time Frame: Assessed at the end of the 6 month trial period ] [ Designated as safety issue: No ]
  • Change in weight from baseline values [ Time Frame: Measured at baseline and 6 months ] [ Designated as safety issue: No ]
  • Change in basal insulin dose from baseline values [ Time Frame: Assessed at baseline and 6 months ] [ Designated as safety issue: No ]
  • Confidence of subjects to use the CGM device measured using a certified visual analog scale [ Time Frame: Measured at baseline, 2 weeks, 3 months and 6 months ] [ Designated as safety issue: No ]
  • Subject satisfaction with their diabetes treatment quantified through the use of the verified ITSQ questionnaire. [ Time Frame: Measured at baseline 3 months, and 6 months ] [ Designated as safety issue: No ]
  • Subject stress measured using the DDS verified questionnaire [ Time Frame: Measured at baseline, 3 months, and 6 months ] [ Designated as safety issue: No ]
  • Diabetes symptoms measured using the DSM verified questionnaire [ Time Frame: Measured at baseline, 3 months, and 6 months ] [ Designated as safety issue: No ]
  • The difference in overall diabetes management between subjects who choose to use the device software versus those who do not. This will be measured using a certified DUVAS and the DDS, DSM, and ITSQ verified questionnaires [ Time Frame: Measured at baseline, 3 months, 6 months ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: April 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Basal insulin, approved oral medications

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01341067

Locations
United States, Idaho
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, United States, 83404
Sponsors and Collaborators
Rocky Mountain Diabetes and Osteoporosis Center
Investigators
Principal Investigator: David R. Liljenquist, MD Rocky Mountain Diabetes and Osteoporosis Center
  More Information

No publications provided

Responsible Party: David Liljenquist, M.D., Primary Investigator, Rocky Mountain Diabetes and Osteoporosis Center
ClinicalTrials.gov Identifier: NCT01341067     History of Changes
Other Study ID Numbers: RMDC-001
Study First Received: April 21, 2011
Last Updated: March 12, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 16, 2014