Pilot Study of Glycemic Control in Diabetic Hemodialyzed Patients (GlyCEDIA)
2013년 4월 9일 업데이트: Centre Europeen d'Etude du Diabete
Glycemic Control Assessed by Continuous Glucose Monitoring in Hemodialyzed Patients With Diabetes Mellitus Treated Via the Basal-Bolus Detemir-Aspart Insulin Regimen: A Pilot Study
The purpose of the study is to evaluate the effect of the basal-bolus detemir-aspart insulin regimen coupled with continuous glucose monitoring (CGM) on glycemic control in hemodialyzed patients with diabetes
연구 개요
상세 설명
We conducted a pilot prospective multicenter study in five French centers (Strasbourg University Hospital, Strasbourg Sainte Anne Hospital, Colmar, Mulhouse, Valenciennes) designed to evaluate the feasibility and effects of a 3 month treatment regimen with rapid-acting insulin and basal long-acting insulin analogues (i.e., aspart and detemir, respectively) along with CGM on glucose level control in diabetic hemodialyzed patients.
All patients who were admitted to the nephrology departments and matched the inclusion criteria between January 1st, 2010, and June 30th, 2012, were consecutively included in the study. CGM was used to analyze blood glucose excursions at baseline and 1 and 3 months of treatment. It was started during the first dialysis session and then continued for the next two days at home under ambulatory conditions. The CGM was continued during the next dialysis session. Therefore, in total, CGM (Navigator®; Abbott, Rungis, France) was performed for 54 hours, including two consecutive hemodialysis sessions and at 0, 1, and 3 months of treatment. The probe for the system was subcutaneously inserted at the beginning of the first dialysis session to analyze interstitial glucose, and it was removed at the end of the second dialysis session. Due to the time required for CGM calibration, plasma glucose levels were only partially recorded during the first dialysis session.
연구 유형
중재적
등록 (실제)
38
단계
- 4단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Colmar, 프랑스, 68000
- Regional Hospital of Colmar
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Mulhouse, 프랑스, 68100
- Regional Hospital of Mulhouse
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Strasbourg, 프랑스, 67000
- University Hospital of Strasbourg
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Strasbourg, 프랑스, 67000
- Sainte Anne Hospital
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Valenciennes, 프랑스, 59300
- Regional Hospital of Valenciennes
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- age between 18 and 83 years
- diagnosis of type 1 or type 2 diabetes
- treatment with insulin injections or oral hypoglycemic agents
- HbA1c ≥ 7% (i.e., 53 mmol/mol)
- on hemodialysis for more than three months
Exclusion Criteria:
- unstable anemia or blood transfusions within the two months prior to the beginning of the study
- a life expectancy of less than 1 year
- chronic inflammatory disease
- evolutive cancer requiring steroid treatment, chemotherapy, radiotherapy, or programmed surgery
- noncompliant patients
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Basal-bolus specific insulin regimen
Basal-bolus detemir-aspart insulin regimen in hemodialyzed diabetic patients
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After the first CGM was completed during the conventional anti-diabetic treatment, patients received a rapid-acting insulin analogue before each meal (i.e., aspart) and a basal long-acting insulin analogue (i.e., detemir) once or twice daily.
The analogues were titrated for optimal glycemic control.
After one month of the aspart and detemir regimen, a physician adapted the insulin doses according to the glucose values observed from the second CGM.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Mean plasma glucose level measured 3 times just before the first hemodialysis session
기간: Baseline and at 3 months of treatment
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Determination by the glucose dehydrogenase method
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Baseline and at 3 months of treatment
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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HbA1c
기간: Baseline and at 3 months of treatment
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Measured by high-performance liquid chromatography
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Baseline and at 3 months of treatment
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Body weight
기간: Baseline and at 1 month and 3 months of treatment
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Baseline and at 1 month and 3 months of treatment
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Insulin requirements
기간: Baseline and at 1 month and 3 months of treatment
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IU per day
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Baseline and at 1 month and 3 months of treatment
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Symptomatic hypoglycemia
기간: Baseline and at 1 month and 3 months of treatment
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Number of glycemia < 60 mg/dl per patient and per month
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Baseline and at 1 month and 3 months of treatment
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Continuous glucose monitoring parameters
기간: Baseline and at 1 month and 3 months of treatment
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Including: mean continuous glucose monitoring glucose values, within-subjects standard deviation (wSD) and coefficient of variation (wCV = wSD/mean), mean amplitude of glycemic excursion (MAGE), frequency of glucose values under 60 mg/dl, and frequency of glucose values higher than 180 mg/dl
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Baseline and at 1 month and 3 months of treatment
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Deaths and major cardiovascular events
기간: Baseline and at 3 months of treatment
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All-cause mortality Major cardiovascular events including: myocardial infarction, stroke, and peripheral vascular disease
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Baseline and at 3 months of treatment
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 책임자: Laurence Kessler, PhD, University Hospital of Strasbourg
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
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- Sattar A, Argyropoulos C, Weissfeld L, Younas N, Fried L, Kellum JA, Unruh M. All-cause and cause-specific mortality associated with diabetes in prevalent hemodialysis patients. BMC Nephrol. 2012 Oct 1;13:130. doi: 10.1186/1471-2369-13-130.
- Oomichi T, Emoto M, Tabata T, Morioka T, Tsujimoto Y, Tahara H, Shoji T, Nishizawa Y. Impact of glycemic control on survival of diabetic patients on chronic regular hemodialysis: a 7-year observational study. Diabetes Care. 2006 Jul;29(7):1496-500. doi: 10.2337/dc05-1887.
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연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2010년 1월 1일
기본 완료 (실제)
2012년 9월 1일
연구 완료 (실제)
2012년 9월 1일
연구 등록 날짜
최초 제출
2013년 4월 9일
QC 기준을 충족하는 최초 제출
2013년 4월 9일
처음 게시됨 (추정)
2013년 4월 11일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2013년 4월 11일
QC 기준을 충족하는 마지막 업데이트 제출
2013년 4월 9일
마지막으로 확인됨
2013년 4월 1일
추가 정보
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