NCT00985257

Brief Summary

The purpose of this study is to evaluate the performance of a new blood glucose meter in the hands of children, teens, young adults.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started Sep 2009

Shorter than P25 for not_applicable diabetes

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

September 24, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 28, 2009

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

November 2, 2010

Completed
Last Updated

February 29, 2016

Status Verified

January 1, 2016

Enrollment Period

1 month

First QC Date

September 24, 2009

Results QC Date

April 6, 2010

Last Update Submit

January 29, 2016

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

  • Percent of Blood Glucose (BG) Results Within +/-15mg/dL or +/-20% of Laboratory Glucose Method

    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.

    1-2 hours

Study Arms (1)

Subjects with diabetes

OTHER

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.

Device: DIDGET (Investigational Blood Glucose Monitoring System)

Interventions

DIDGET (Investigational Blood Glucose Monitoring System)DEVICE

Subjects with diabetes (with parent/guardian assistance, if applicable)and health care professionals (HCPs) each performed duplicate Blood Glucose (BG) tests from the subject's capillary blood on the DIDGET. To test the full range of glucose concentrations, a venipuncture was performed on some subjects to obtain enough blood for modifying (spiking or glycolyzing) to the extreme glucose concentrations. Results were compared to a laboratory glucose method - the Yellow Springs Instrument (YSI) Analyzer.

Subjects with diabetes

Eligibility Criteria

Age4 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Type 1 or Type 2 diabetes
  • Age 4 to 24 years
  • Routinely performs blood glucose testing at home
  • If age 18 or older at time informed consent is signed, subject must be able to speak, read, and understand English.
  • If younger than age 18, subject's parent/guardian must be able to speak, read, and understand English, and is able to provide appropriate supervision.
  • Is willing to complete all study procedures, with or without parent / guardian supervision, if appropriate

You may not qualify if:

  • Currently pregnant
  • Hemophilia or any other bleeding disorder
  • Taking prescription anticoagulants (such as Warfarin or heparin) or has clotting problems that may prolong bleeding. Taking Plavix or aspirin daily is not excluded
  • Infection with a blood borne pathogen (e.g., HIV, hepatitis)
  • Subject or parent/guardian is employee of competitive medical device company
  • Cognitive disorder or other condition, which in the opinion of the investigator, would put the person at risk or seriously compromise the integrity of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

AMCR Institute

Escondido, California, 92026, United States

Location

Larry C. Deeb, MD PA

Tallahassee, Florida, 32308, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Carmine Greene, Senior Clinical Research Scientist
Organization
Ascensia Diabetes Care
carmine.greene@ascensia.com
574-257-3040

Study Officials

  • Timothy Bailey, MD

    AMCR Institute

    PRINCIPAL INVESTIGATOR

  • Larry C Deeb, MD PA

    Larry C. Deeb, MD PA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2009

First Posted

September 28, 2009

Study Start

September 1, 2009

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

February 29, 2016

Results First Posted

November 2, 2010

Record last verified: 2016-01

Locations

US(2)