임상 레이더 AI | ||
|---|---|---|
임상시험 NCT00598663 (SWITCH)은(는) 제1형 당뇨병에 대해 완료 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
SWITCH - Sensing With Insulin Pump Therapy to Control HbA1c 153
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT00598663 (SWITCH)은(는) 제1형 당뇨병에 대해 알아본 중재연구입니다. 현재 상태는 완료입니다. 연구는 2008년 1월 1일에 시작되어 153명의 참여자와 함께 진행되었습니다. Medtronic Diabetes이(가) 진행한 이 연구는 2010년 7월 1일에 마무리되었습니다. ClinicalTrials.gov의 가장 최근 정보는 2019년 9월 16일에 갱신되었습니다.
간단한 개요
The primary objective of this study is to evaluate whether the patients with Type 1 diabetes mellitus in sub-optimal glycemic control can achieve better glycemic control by using the Medtronic MiniMed Paradigm® REAL-Time Pump System with continuous glucose monitoring versus the Medtronic MiniMed Paradigm® REAL-Time Pump alone with Self Monitoring Blood Glucose (SMBG).Our null hypothesis is there is a 0% reduction in ...더 보기
공식 제목
Randomized, Cross Over, Controlled, Multi-centric Study to Assess Whether Type 1 Diabetic Patients in Sub-optimal Glycemic Control Can Improve Using the Continuous Glucose Values of the MiniMed Paradigm REAL-Time Insulin Pump System Versus the MiniMed Paradigm Insulin Pump
질환명
제1형 당뇨병출판물
이 임상시험에 대해 발표된 과학 논문 및 연구 자료.기타 연구 식별자
- SWITCH
- EUR03
- ISRCTN09806152
NCT 번호
실제 연구 시작일
2008-01
최신 업데이트 게시
2019-09-16
예상 연구 완료일
2010-07
계획된 등록 인원
153
연구종류
중재연구
단계/상
해당 없음
상태
완료
키워드
Type 1 diabetes
주요 목적
치료
설계 할당
무작위배정
중재 모델
교차 설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Off/On 6 month-Period Off: Continuous Subcutaneous Insulin Infusion (CSII) and Self Monitoring Blood Glucose \[Device: Paradigm® Real-Time pump with Sensor Off feature\]
4 month wash out period
6 month-Period On: Continuous Subcutaneous Insulin Infusion (CSII) + personal continuous glucose monitoring (personal CGM) \[Device: Paradigm® Real-Time pump with Sensor On feature continuously\] | insulin pump with continuous glucose sensing (Paradigm Real-Time Insulin Pump System) 6 months of pump plus continuous glucose sensing in conjunction to SMBG |
실험적On/Off 6 month-Period On: Continuous Subcutaneous Insulin Infusion (CSII) + personal continuous glucose monitoring (personal CGM) \[Device: Paradigm® Real-Time pump with Sensor On feature continuously\]
4 month wash out period
6 month-Period Off: Continuous Subcutaneous Insulin Infusion (CSII) and Self Monitoring Blood Glucose \[Device: Paradigm® Real-Time pump with Sensor Off feature\] | insulin pump and blinded continuous glucose sensing (Paradigm Real-Time insulin pump) insulin pump with smbg to be worn for 6 months. 15 days in each 6 week period blinded continuous glucose sensing will be conducted. |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
HbA1c at 6 Month | The end of period difference in HbA1c after 6 months of treatment | 6 months |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Glycemic Variability | 24 h SD of glucose values (mg/dl) | 6 months |
Number of Severe Hypoglycemia Events | 6 months | |
Daily Min Spent in Euglycaemia (3.9-10.0 mmol/l) | 6 months | |
Postprandial Glycaemia | Breakfast Postprandial glycaemia | 6 months |
Pediatric Quality of Life Inventory (Vers 4.0; PedsQL) | This questionnaire is a validated assessment of health-related quality of life in children developed by J.W. Varni, (1998).
Scores are transformed on a scale from 0 to 100. higher values represent a better outcome | 6 months |
Diabetic Ketoacidosis Events | A diabetic ketoacidosis event (DKE) is defined as a hyperglycemia (blood glucose \>250 mg/dL) with either low serum bicarbonate (\<15 mEq/L) and/or low pH (\<7.3) and either ketonemia or ketonuria and requiring treatment within a health-care facility. | 6 months |
적격성 기준
연령대
어린이, 성인, 노인
최소 연령
6 Years
참여 가능한 성별
전체
건강한 참가자 허용
네
- Type 1 diabetes mellitus diagnosed for at least 12 months prior to signature of informed consent,
- Sub-optimal glycemic control (7.5%<HbA1c<9.5%).
- Patient treated by continuous subcutaneous insulin infusion (CSII) for at least 6 months prior signature of informed consent.
- Patient treated within the practice of the investigator's center at least 6 months prior signature of informed consent.
- Patient has no preliminary experience with the sensor function of the Paradigm REAL-Time or the Guardian® REAL-Time for the 4 months prior signature of informed consent.
- Existing pregnancy or intention to conceive (as assessed by investigator).
- Hearing or vision impairment so that glucose display and alarms cannot be recognized.
- Three or more incidents in the last 12 months of severe hypoglycaemia with documented Blood Glucose below 50mg/dL (if possible), resulting in unconsciousness, hospitalisation or third party assistance, where recovery follows treatment with glucose or glucagon or similar.
- History of hypoglycemic unawareness as assessed by the investigator.
- Alcohol or drug abuse, other than nicotine.
- Documented cutaneous allergy or disease (allergy to sensor or components of the sensor, psoriasis, staphylococcus, exanthema etc.).
- Any documented concomitant chronic disease known to affect diabetes control (e.g. altered renal function, active cancer undergoing treatment, Crohn's disease, ulcerative colitis, Mb Addison disease) or any concomitant pharmacological treatment that might modify glycemic values (e.g chronic corticosteroid therapy), eating disorders and morbid obesity (defined as adults : Body Mass Index >35 and children Body Mass Index > 2 standard deviations. for age) as assessed by the investigator.
- Any other medical, social or psychological condition that, in the investigator's opinion, makes the patient unable to comply with the study protocol and all study procedures.
- For pediatric subjects: does not have a reliable support person.
- Plans to travel for extended periods (3+ weeks) where the devices cannot be supplied or replaced and/or medical support is limited (eg. exotic countries, remote places).
- Participation in another clinical study, on-going or completed less than 3 months prior to signature of Patient Informed Consent.
Medtronic Diabetes연락처 정보가 없습니다.
8 7개국에 임상시험 장소
Hospital Hietzing, Vienna, Austria
Steno Diabetes Center, Copenhagen, Denmark
Glostrup Hospital, Glostrup Municipality, Denmark
Clinica Pediatrica, Policlinico Umberto I, Rome, Italy
Center Hospitalier de Luxembourg, Luxembourg, Luxembourg
Groene Hart Ziekenhuis, Gouda, Netherlands
University Children's Hospital, Ljubljana, Slovenia
Hospital Clinic i Universitari, Barcelona, Spain