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Performance of a New Glucose Meter System in Children and Young Adults

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ClinicalTrials.gov Identifier: NCT00985257
Recruitment Status : Completed
First Posted : September 28, 2009
Results First Posted : November 2, 2010
Last Update Posted : February 29, 2016
Sponsor:
Information provided by (Responsible Party):
Ascensia Diabetes Care

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Diabetes
Intervention Device: DIDGET (Investigational Blood Glucose Monitoring System)
Enrollment 123
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Subjects With Diabetes
Hide Arm/Group Description Subjects with diabetes (or parents/guardians, if applicable)and healthcare professionals (HCPs) use a new blood glucose monitoring system. Subjects were 4 to 24 years of age with type 1 and type 2 diabetes.
Period Title: Overall Study
Started 123
Completed 123
Not Completed 0
Arm/Group Title Subjects With Diabetes
Hide Arm/Group Description Subjects with diabetes (or parents/guardians, if applicable)and healthcare professionals (HCPs) use a new blood glucose monitoring system. Subjects were 4 to 24 years of age with type 1 and type 2 diabetes.
Overall Number of Baseline Participants 123
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 123 participants
Age 4-12 years 41
Age 13 to 17 years 30
Age 18 to 24 years 52
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 123 participants
Female
69
  56.1%
Male
54
  43.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 123 participants
123
1.Primary Outcome
Title Percent of Blood Glucose (BG) Results Within +/-15mg/dL or +/-20% of Laboratory Glucose Method
Hide Description Subjects with diabetes and healthcare professionals (HCPs) used a new blood glucose monitoring system (BGMS) with subject blood. BGM results were compared to a lab glucose method - Yellow Springs Instrument (YSI) Analyzer. Duplicate BG results were used to calculate the number of BG results within +/-15mg/dL (for reference BG results <75mg/dL) or +/- 20% (for reference BG values >/=75mg/dL) of the reference method results.
Time Frame 1-2 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
To achieve glucose concentrations across the meter test range, 47 blood samples were modified. The total glucose distribution (total 121 natural capillary samples plus 47 modified) ranged from 25.7 to 563.5mg/dL. Two sets of subject results were not analyzed because sufficient sample was not obtained for the YSI reference test.
Arm/Group Title Subjects With Diabetes
Hide Arm/Group Description:
Subjects with diabetes (or parents/guardians, if applicable)and healthcare professionals (HCPs) use a new blood glucose monitoring system. Subjects were 4 to 24 years of age with type 1 and type 2 diabetes.
Overall Number of Participants Analyzed 121
Overall Number of Units Analyzed
Type of Units Analyzed: Capillary blood glucose results
242
Measure Type: Number
Unit of Measure: percent of blood glucose results
Subject Tests Natural Capillary n=242=2 x 121 97.1
Combine Natural+Modified n=336=2 x (121+47) 97.9
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Subjects With Diabetes
Hide Arm/Group Description Subjects with diabetes (or parents/guardians, if applicable)and healthcare professionals (HCPs) use a new blood glucose monitoring system. Subjects were 4 to 24 years of age with type 1 and type 2 diabetes.
All-Cause Mortality
Subjects With Diabetes
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Subjects With Diabetes
Affected / at Risk (%)
Total   0/123 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Subjects With Diabetes
Affected / at Risk (%)
Total   0/123 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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: Carmine Greene, Senior Clinical Research Scientist
Organization: Ascensia Diabetes Care
Phone: 574-257-3040
Responsible Party: Ascensia Diabetes Care
ClinicalTrials.gov Identifier: NCT00985257     History of Changes
Other Study ID Numbers: CTD-2009-35
First Submitted: September 24, 2009
First Posted: September 28, 2009
Results First Submitted: April 6, 2010
Results First Posted: November 2, 2010
Last Update Posted: February 29, 2016