Evaluation of an Karajishi Contour Investigational Blood Glucose Monitoring System (ISO/FDA Study)
2016年1月29日 更新者：Ascensia Diabetes Care
User Performance of the Karajishi Contour Blood Glucose Monitoring System (ISO/FDA Study)
The purpose of this study was to determine if untrained persons with diabetes and without diabetes could operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid blood glucose results.
調査の概要
状態
完了
条件
研究の種類
介入
入学 (実際)
372
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
California
-
Escondido、California、アメリカ、92026
- AMCR Institute
-
-
Washington
-
Renton、Washington、アメリカ、98057
- Rainier Clinical Research Center
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Males and females, 18 years of age and older
- Able to speak, read, and understand English
- Willing to complete all study procedures
Exclusion Criteria:
- Hemophilia or any other bleeding disorder
- Pregnancy
- Physical, visual, or neurological impairments that would make the person unable to perform testing with the BGM
- Previously participated in a BG monitor study using the Karajishi Contour BGMS (or used a Bayer Contour meter)
- Work for a medical laboratory, hospital, or other clinical setting that involves training on and clinical use of blood glucose monitors
- Work for a competitive medical device company, or having an immediate family member who works for such a company
- A condition which, in the opinion of the investigator or designee, would put the person or study conduct at risk
General enrollment guidelines:
- Most subjects will be persons with type 1 or type 2 diabetes
- At least 10% of subjects with diabetes will have type 1 diabetes
- Approximately 10% of subjects will be persons without diabetes
- At least 60% of subjects will be younger than age 65
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：非ランダム化
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Persons With Diabetes
Untrained subjects WITH Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).
|
Untrained subjects WITH diabetes use the Karajishi Contour BGMS (Blood Glucose Monitoring System).
Subjects tested capillary fingerstick blood (and study staff tested subject fingerstick blood) using the Karajishi Contour BGMS.
All BG results were compared to reference method results obtained with subject capillary plasma.
Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma.
|
|
実験的：Persons With and Without Diabetes
Untrained subjects WITH/WITHOUT Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).
|
Untrained subjects WITH and WITHOUT diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).
Subjects tested capillary fingerstick blood (and study staff tested subject fingerstick blood) using the Karajishi Contour BGMS.
All BG results were compared to reference method results obtained with subject capillary plasma.
Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method
時間枠：1 hour
|
Untrained subjects WITH diabetes (329) self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS).
BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer.
YSI Analyzer BG results were used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI capillary plasma) and +/-15% (>=100 mg/dL YSI capillary plasma).
|
1 hour
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Venous Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method
時間枠：1 hour
|
Study staff tested venous blood of subjects WITH diabetes (329) using an investigational Blood Glucose Monitoring System (BGMS).
Venous BGMS results were compared with subject venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer.
YSI Analyzer venous plasma BG results were used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI venous plasma) and +/-15% (>=100 mg/dL YSI venous plasma).
|
1 hour
|
|
Number of Fingerstick Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method When Obtained and Tested by Study Staff
時間枠：1 hour
|
Study staff obtained and tested subject (329 WITH diabetes) fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS).
BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer.
YSI capillary plasma results were used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI capillary plasma) and +/-15% (>=100 mg/dL YSI capillary plasma).
|
1 hour
|
|
Number of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements
時間枠：1 hour
|
Staff obtained responses from persons WITH diabetes (329) using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS.
Subjects could respond 'Strongly Agree' or 'Agree' or 'Neutral' or 'Disagree' or 'Strongly Disagree.'
|
1 hour
|
|
Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method Across the Tested Glucose Range
時間枠：1 hour
|
Untrained subjects WITH diabetes (329) and WITHOUT diabetes (43) self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS).
BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer.
YSI Analyzer BG results were used to calculate the number of BGMS results within +/-15% of the laboratory method across the entire tested YSI glucose range.
|
1 hour
|
|
Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method Across the Tested Glucose Range
時間枠：1 hour
|
Untrained subjects WITH diabetes (329) and WITHOUT diabetes (43) self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS).
BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer.
YSI Analyzer BG results were used to calculate the number of BGMS results within +/-20% of the laboratory method across the entire tested YSI glucose range.
|
1 hour
|
|
Number of Subject Fingerstick Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method When Obtained and Tested by Study Staff
時間枠：1 hour
|
Study staff obtained and tested subject (WITH and WITHOUT diabetes) fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS).
BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer.
YSI capillary plasma results were used to calculate the number of BGMS results within +/-15% across the tested YSI glucose range.
|
1 hour
|
|
Number of Subject Fingerstick Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method When Obtained and Tested by Study Staff
時間枠：1 hour
|
Study staff obtained and tested subject (WITH and WITHOUT diabetes) fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS).
BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer.
YSI capillary plasma results were used to calculate the number of BGMS results within +/-20% across the tested YSI glucose range.
|
1 hour
|
|
Number of Subject Responses That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements
時間枠：1 hour
|
Staff obtained responses from subjects WITH and WITHOUT diabetes using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS.
Subjects could respond 'Strongly Agree' or 'Agree' or 'Neutral' or 'Disagree' or 'Strongly Disagree.'
|
1 hour
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Leslie J Klaff, MD、Rainier Clinical Research Center
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2014年6月1日
一次修了 (実際)
2014年6月1日
研究の完了 (実際)
2014年6月1日
試験登録日
最初に提出
2014年5月27日
QC基準を満たした最初の提出物
2014年5月27日
最初の投稿 (見積もり)
2014年5月29日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年2月29日
QC基準を満たした最後の更新が送信されました
2016年1月29日
最終確認日
2015年6月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- GCA-2014-002-01
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。