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Trial record 24 of 2645 for:    ( Map: Idaho, United States )

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01341067
Recruitment Status : Completed
First Posted : April 25, 2011
Results First Posted : May 2, 2014
Last Update Posted : May 2, 2014
Sponsor:
Information provided by (Responsible Party):
David Liljenquist, M.D., Rocky Mountain Diabetes and Osteoporosis Center

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Type 2 Diabetes Mellitus
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Basal Insulin, Approved Oral Medications
Hide Arm/Group Description Basal insulin, with or without approved oral agents
Period Title: Overall Study
Started 30
Completed 26
Not Completed 4
Arm/Group Title Basal Insulin, Approved Oral Medications
Hide Arm/Group Description Basal insulin, with or without approved oral agents
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
<=18 years
0
   0.0%
Between 18 and 65 years
21
  70.0%
>=65 years
9
  30.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants
58  (12.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
17
  56.7%
Male
13
  43.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants
30
1.Primary Outcome
Title Change in HgbA1c
Hide Description [Not Specified]
Time Frame Measured at 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Basal Insulin, Approved Oral Medications
Hide Arm/Group Description:
Basal insulin, with or without approved oral agents
Overall Number of Participants Analyzed 26
Mean (Standard Deviation)
Unit of Measure: percentage of glycosylated hemoglobin
-1.9  (1.1)
2.Secondary Outcome
Title Percentage of Time Spent at Glycemic Levels <65 mg/dl
Hide Description [Not Specified]
Time Frame Measured at baseline and at 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Basal Insulin, Approved Oral Medications
Hide Arm/Group Description:
Basal insulin, with or without approved oral agents
Overall Number of Participants Analyzed 26
Mean (Standard Deviation)
Unit of Measure: percentage of time spent < 65 mg/dl
.04  (1.0)
3.Secondary Outcome
Title Change in Percentage of Time Spent at Glycemic Levels >180 mg/dl
Hide Description [Not Specified]
Time Frame Measured at baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Basal Insulin, Approved Oral Medications
Hide Arm/Group Description:
Basal insulin, with or without approved oral agents
Overall Number of Participants Analyzed 26
Mean (Standard Deviation)
Unit of Measure: percentage of time spent >180 mg/dl
-8.5  (16.9)
4.Secondary Outcome
Title Change in Basal Insulin Dose From Baseline Values
Hide Description [Not Specified]
Time Frame Assessed at baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Basal Insulin, Approved Oral Medications
Hide Arm/Group Description:
Basal insulin, with or without approved oral agents
Overall Number of Participants Analyzed 26
Mean (Standard Deviation)
Unit of Measure: units of insulin
0.3  (16.7)
Time Frame [Not Specified]
Adverse Event Reporting Description 0 serious adverse events were recorded. 3 device related adverse events were recorded.
 
Arm/Group Title Basal Insulin, Approved Oral Medications
Hide Arm/Group Description Basal insulin, with or without approved oral agents
All-Cause Mortality
Basal Insulin, Approved Oral Medications
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Basal Insulin, Approved Oral Medications
Affected / at Risk (%) # Events
Total   0/30 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Basal Insulin, Approved Oral Medications
Affected / at Risk (%) # Events
Total   3/30 (10.00%)    
Skin and subcutaneous tissue disorders   
Insertion site irritation [1]  3/30 (10.00%)  3
[1]
Includes mild irritation at the site of insertion that has been deemed to be device related by the Primary Investigator.
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
Layout table for Results Point of Contact information
Name/Title: Mark Sulik, PharmD CCRP
Organization: Rocky Mountain Diabetes and Osteoporosis Center
Phone: 208-528-9642
EMail: mark@idahomed.com
Layout table for additonal information
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
First Submitted: April 21, 2011
First Posted: April 25, 2011
Results First Submitted: March 22, 2013
Results First Posted: May 2, 2014
Last Update Posted: May 2, 2014