- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03047486
Smartguard Use in Real Life : a Longitudinal Study in Patients With Type 1 Diabetes (Smartguard)
The reference treatment of the type 1 diabetes is intensified insulin therapy by insulin pump. The CGM (continuous glucose monitoring) is a technology available for a decade, which allows the continuous measure of interstitial glucose rate. The results are available in real time to the user, who can so use them to optimize the adjustment of its treatment by insulin pump. Since a few years, several research programs aim for finalizing an automated system using the data of real time interstitial glucose to adjust automatically, via an algorithm, the release of insulin by the pump. This type of closed-loop system is for the moment only experimental, not still widely available in routine. On the other hand, rudimentary regulation systems partially automated already exist and can be used in common clinical practice. One of these systems, Smartguard ®, allows this type of regulation to decrease the hypoglycemic risk of the patients treated by insulin pump. It is indeed a hypo minimizer which interrupts the basal output when the algorithm embarked on the pump determines thanks to the CGM data what a hypoglycemia risks to occur in the 30 minutes. The efficiency of this system to reduce hypoglycemias was proved by several studies in pediatric and adult populations of subjects with DT1 (Diabetes Care on 2015; 38:1197-1204. J Diabetes Sci Technol. 2016 May 20. Pii: 1932296816645119). However, to date, there are no published data concerning the method of use of this system (sensor et pump initial configuration; patient education), nor the evolution of the sensor and pump parameters during the use.
The aim of this observationnelle study is to collect the data of efficiency, safety and use of the system Smartguard ® in common clinical practice in an adult population of subjects DT1.
연구 개요
상태
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Caen, 프랑스, 14000
- Endocrinology Unit and Clinical Research Center Basse Normandie, University Hospital of Caen
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Type 1 diabetes ≥ 1 year
- CSII ≥ 6 months
- Previous education to flexible insulin therapy
- Patient willing to use sensors and smartguard option for 1 year
- A1c ≥ 7.5% and/or severe hypoglycemia ≥ 2 episodes during the last 6 month and/or recurrent hypoglycemia and/or hypoglycemia unawareness and/or brittle diabetes
Exclusion Criteria:
- No access to a computer and/or to the web making it impossible to follow patients through telemedicine
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Glucose TIR (time in range) from CGM recording
기간: change between baseline and after 12 month
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TIR will be calculated from the CGM recording, thanks to the medtronic carelink software
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change between baseline and after 12 month
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Glucose Time below range (hypoglycemia < 70 mg/dl) from CGM recording
기간: change between baseline and after 12 month
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Time below range will be calculated from the CGM recording, thanks to the medtronic carelink software
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change between baseline and after 12 month
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2차 결과 측정
결과 측정 |
기간 |
---|---|
HbA1c
기간: month 0, 3, 6, 9, 12
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month 0, 3, 6, 9, 12
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기타 결과 측정
결과 측정 |
기간 |
---|---|
daily insulin total dose
기간: month 0, 3, 6, 9, 12
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month 0, 3, 6, 9, 12
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basal / bolus ratio
기간: month 0, 3, 6, 9, 12
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month 0, 3, 6, 9, 12
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daily bolus number
기간: month 0, 3, 6, 9, 12
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month 0, 3, 6, 9, 12
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Mean daily hypoglycemic predictive-stop time
기간: month 0, 3, 6, 9, 12
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month 0, 3, 6, 9, 12
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Mean daily hypoglycemic-stop time
기간: month 0, 3, 6, 9, 12
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month 0, 3, 6, 9, 12
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Time Percentage with CGM Sensor Use Time
기간: month 0, 3, 6, 9, 12
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month 0, 3, 6, 9, 12
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Medical time at each consultation
기간: month 0, 3, 6, 9, 12
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month 0, 3, 6, 9, 12
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공동 작업자 및 조사자
수사관
- 수석 연구원: Michael JOUBERT, MD, University Hospital, Caen
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .