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User Evaluation of the Invasive Component of the CNOGA TensorTip COMBO GLUCOMETER (CoG)

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: NCT03870971
Recruitment Status : Completed
First Posted : March 12, 2019
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
Cnoga Medical Ltd.
Information provided by (Responsible Party):
Sciema UG

Tracking Information
First Submitted Date  ICMJE February 12, 2019
First Posted Date  ICMJE March 12, 2019
Last Update Posted Date January 18, 2020
Actual Study Start Date  ICMJE February 4, 2019
Actual Primary Completion Date July 8, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 8, 2019)
measurement performance [ Time Frame: up to 1 day ]
invasive CoG (study device) blood glucose measurement in comparison to blood glucose measurment of a comparator device (YSI 2300 STAT Plus).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE User Evaluation of the Invasive Component of the CNOGA TensorTip COMBO GLUCOMETER (CoG)
Official Title  ICMJE User Evaluation of the Invasive Component of the CNOGA TensorTip COMBO GLUCOMETER (CoG)
Brief Summary Open label, prospective, comparative, multi-center study. All participants will get an introduction to the invasive component of the TENSORTIP COG by means of the instructions for use in English language only (incl. an illustrated short manual) and will be asked to perform a reading without further device training. Thereafter, a healthcare professional will perform an additional reading with the reference method (YSI 2300 STAT plus). In addition, blood will be drawn for determination of hematocrit. In the study, a minimum of 10 test strip vials that cover a minimum of 3 strip lots will be used. In addition multiple devices will be employed. After completion of the study the study participants will be given a questionnaire to fill out.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Diabetes Mellitus
Intervention  ICMJE Other: blood glucose measurement
After the patient has performed the manual reading, the investigator or staff member will obtain another capillary blood sample and a reference reading by means of the YSI 2300 Stat plus analyzer will be performed and recorded. If patients need more than one attempt to get a successful blood glucose reading, the number of attempts will be documented. A questionnaire needs to filled by the participant
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 14, 2020)
543
Original Estimated Enrollment  ICMJE
 (submitted: March 8, 2019)
200
Actual Study Completion Date  ICMJE August 31, 2019
Actual Primary Completion Date July 8, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • patients with type 1 or type 2 diabetes or healthy
  • Subjects who are able to complete informed consent form (by him/herself or by his/her guardian);
  • 18 years old and above;

Exclusion Criteria:

  • Does not meet inclusion criteria;
  • Subjects with any other severe disease in the discretion of the investigator
  • Not capable to read English user instructions at the discretion of the patient
  • Pregnancy or Nursing mothers
  • Any condition that may prevent participants from successful participation in the trial (in discretion of the investigator)
  • Illiteracy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03870971
Other Study ID Numbers  ICMJE CNG-NGM-005
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sciema UG
Study Sponsor  ICMJE Sciema UG
Collaborators  ICMJE Cnoga Medical Ltd.
Investigators  ICMJE Not Provided
PRS Account Sciema UG
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP