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: April 1, 2014
Last verified: April 2014
Results First Received: March 22, 2013  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Type 2 Diabetes Mellitus

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Basal Insulin, Approved Oral Medications Basal insulin, with or without approved oral agents

Participant Flow:   Overall Study
    Basal Insulin, Approved Oral Medications  
STARTED     30  
COMPLETED     26  
NOT COMPLETED     4  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Basal Insulin, Approved Oral Medications Basal insulin, with or without approved oral agents

Baseline Measures
    Basal Insulin, Approved Oral Medications  
Number of Participants  
[units: participants]
  30  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     21  
>=65 years     9  
Age  
[units: years]
Mean ± Standard Deviation
  58  ± 12.4  
Gender  
[units: participants]
 
Female     17  
Male     13  
Region of Enrollment  
[units: participants]
 
United States     30  



  Outcome Measures
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1.  Primary:   Change in HgbA1c   [ Time Frame: Measured at 6 months ]

2.  Secondary:   Percentage of Time Spent at Glycemic Levels <65 mg/dl   [ Time Frame: Measured at baseline and at 6 months ]

3.  Secondary:   Change in Percentage of Time Spent at Glycemic Levels >180 mg/dl   [ Time Frame: Measured at baseline and 6 months ]

4.  Secondary:   Change in Basal Insulin Dose From Baseline Values   [ Time Frame: Assessed at baseline and 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Mark Sulik, PharmD CCRP
Organization: Rocky Mountain Diabetes and Osteoporosis Center
phone: 208-528-9642
e-mail: mark@idahomed.com


No publications provided


Responsible Party: David Liljenquist, M.D., 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
Results First Received: March 22, 2013
Last Updated: April 1, 2014
Health Authority: United States: Food and Drug Administration