Insulin Therapy in the Hospital Comparing Two Protocols
2009년 9월 8일 업데이트: John H. Stroger Hospital
Basal/Bolus Insulin Therapy in the Hospital Ward Comparison of Two Protocols: Feasibility Study
The purpose of this study is to determine if by using insulin analog (Glargine and lispro insulin) with an insulin pen the investigators are able to obtain a higher rate of correct timing of insulin and food administration as when compared to the usual therapy (insulin NPH and regular) with syringes.
연구 개요
상태
완전한
정황
연구 유형
중재적
등록 (예상)
60
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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Illinois
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Chicago, Illinois, 미국, 60612
- John H Stroger Jr. Hospital
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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:
Uncontrolled blood sugar:
- Random blood sugar ≥ 200mg/dl
- Pre-prandial blood sugar greater than 180 mg/dl on two occasions within 24 hours.
- Patient may be off insulin or on subcutaneous inpatient insulin regimen less than 36 hours.
- Transition from an Insulin Drip in the intensive care units to subcutaneous insulin upon transfer to general ward.
- Patient is able to eat and oral feeding is expected.
Exclusion Criteria:
- Patients receiving inpatient oral hypoglycemic agents
- Patients with chronic kidney disease stages 4 & 5 (estimated GFR of <30ml/min) and on dialysis
- Patient with chronic liver disease
- Patient with hypoglycemia unawareness
- Pregnancy
- Patients who are on "NPO" for medical reasons.
- Patient is expected to stay in the hospital for less than 3 days.
- Patient on a new inpatient insulin regimen for > 36 hours.
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: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 2
The active control group will receive twice daily NPH insulin as basal insulin and bolus (prandial) insulin as regular insulin to be administered 30 minutes before meals.
The administration of basal (prandial) regular insulin and food will be done as the current usual care on the hospital ward.
The protocol for initial insulin dose and subsequent dose adjustment has been developed by the "Inpatient Diabetes Advisory Group" and is detailed in appendix B. The patient will receive information regarding diabetes treatments, appropriate diet and diabetic self management which will be provided by the nursing and nutritional staff.
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The active control group will receive twice daily NPH insulin as basal insulin and bolus (prandial) insulin as regular insulin to be administered 30 minutes before meals.
The administration of basal (prandial) regular insulin and food will be done as the current usual care on the hospital ward.
The protocol for initial insulin dose and subsequent dose adjustment has been developed by the "Inpatient Diabetes Advisory Group" and is detailed in appendix B. The patient will receive information regarding diabetes treatments, appropriate diet and diabetic self management which will be provided by the nursing and nutritional staff.
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실험적: 1
The study group will receive Insulin Glargine as basal insulin and bolus (prandial) insulin as lispro insulin (choice between pens or vials will be made).
The administration of bolus (prandial) insulin pen or syringe will be delivered concurrently with the food tray (the concept of "insulin pen/syringe on the food tray") by the nursing staff that together with hospital food services identifies the food tray for the patients in the study group.
The protocol for initial insulin dose and subsequent dose adjustment has been developed by the "Inpatient Diabetes Advisory Group" and is detailed in appendix A. The patient will receive information regarding diabetes treatments, appropriate diet and diabetic self management which will be provided by the nursing and nutritional staff
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The study group will receive Insulin Glargine as basal insulin.
The protocol for initial insulin dose and subsequent dose adjustment has been developed by the "Inpatient Diabetes Advisory Group" and is detailed in appendix A. The patient will receive information regarding diabetes treatments, appropriate diet and diabetic self management which will be provided by the nursing and nutritional staff.
다른 이름들:
Bolus (prandial) insulin as lispro insulin (choice between pens or vials will be made).
The administration of bolus (prandial) insulin pen or syringe will be delivered concurrently with the food tray (the concept of "insulin pen/syringe on the food tray") by the nursing staff that together with hospital food services identifies the food tray for the patients in the study group.
The protocol for initial insulin dose and subsequent dose adjustment has been developed by the "Inpatient Diabetes Advisory Group" and is detailed in appendix A. The patient will receive information regarding diabetes treatments, appropriate diet and diabetic self management which will be provided by the nursing and nutritional staff.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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The rate of correct timing of insulin and food administration
기간: Correct time was 30 min before to 30 minutes after meal was given for control group, and 15 minutes before to 15 minutes after in case group
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Correct time was 30 min before to 30 minutes after meal was given for control group, and 15 minutes before to 15 minutes after in case group
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Pre and post- prandial glucose levels
기간: Pre prandial glucose levels were obtained from 0 to 15 minutes before meal , post prandial glucose levels were obtained 2 hours after mealtime
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Pre prandial glucose levels were obtained from 0 to 15 minutes before meal , post prandial glucose levels were obtained 2 hours after mealtime
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Length of hospital stay
기간: Measured 24 hours after patient is dischargerd, from day 1 of admission until day of discharge
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Measured 24 hours after patient is dischargerd, from day 1 of admission until day of discharge
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Nursing staff satisfaction scores for evaluation of the two methods
기간: 24 hours after last patient is discharged
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24 hours after last patient is discharged
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Hypoglycemia rates.
기간: From day 1 of admission until day of discharge, obtained from capillary blood checks done QAC and 2 hours postprandial
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From day 1 of admission until day of discharge, obtained from capillary blood checks done QAC and 2 hours postprandial
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High excursions of blood sugars (>300 mg/dl).
기간: From day 1 of admission until day of discharge, obtained from capillary blood checks done QAC and 2 hours postprandial
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From day 1 of admission until day of discharge, obtained from capillary blood checks done QAC and 2 hours postprandial
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Leon Fogelfeld, MD, John H Stroger Jr. Hospital
- 연구 의자: Evelyn Lacuesta, MD, John H Stroger Jr. Hospital
- 연구 의자: Yannis Guerra, MD, Rush University Hospital
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
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
2006년 12월 1일
기본 완료 (실제)
2009년 3월 1일
연구 완료 (실제)
2009년 6월 1일
연구 등록 날짜
최초 제출
2009년 2월 9일
QC 기준을 충족하는 최초 제출
2009년 2월 11일
처음 게시됨 (추정)
2009년 2월 12일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2009년 9월 9일
QC 기준을 충족하는 마지막 업데이트 제출
2009년 9월 8일
마지막으로 확인됨
2009년 9월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- BBJHS200901
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. .
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