3-Month Trial Observation of A1c Change
Assessment of an Internet Blood Glucose Management Program in a Chronic Care Hospital
연구 개요
상세 설명
Purpose: This project will investigate the benefits (as measured by change in the primary outcome measure hemoglobin A1c) of bi-weekly reporting of blood sugar values for patients with type 2 diabetes in long term care facilities.
Hypothesis: Our hypothesis is bi-weekly reporting will result in a reduction in A1c after 3 months.
Justification: Elevated A1c values increase risk of health complications for people with type 2 diabetes.
Objectives: Improved type 2 diabetes management for patients in long term care facilities.
Research Methods: Patients who meet the inclusion / exclusion criteria and are interested in participating in the study will self-identify to the research coordinator. Consent will be done in person with any questions answered. Strips and blood glucose meters will be provided. Blood glucose values and testing frequency will be recorded using the internet reporting system Heath-e-Connect. HbA1c, serum creatinine and demographic data will be collected at 0 and 3 months to determine effect of bi-weekly remote communication of blood glucose with an endocrinologist.
Statistical Analysis: HbAlc values at 0 and 3 months will be compared using an unpaired t-test to measure the effect of the intervention
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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British Columbia
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Vancouver, British Columbia, 캐나다, V6E 1M7
- Endocrine Research Society
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Type II diabetes mellitus patients at Point Grey Private Hospital
- Trained in self-blood glucose monitoring
- Willingness to test blood glucose levels a minimum of 3 times daily
- Willingness to be trained on IBGMS
Exclusion Criteria:
- Patients with medical conditions that may affect their study participation or results will be excluded.
- Patients currently being treated with steroid medication
- Patients that have impaired liver function
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Internet Intervention
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bi-weekly communication of blood sugars using an internet platform between patients with type 2 diabetes and an endocrinologist
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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HbA1c
기간: 0 and 3 months
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Hemoglobin A1c will be measure at 0 and 3 months to determine the efficacy of the internet blood glucose monitoring system as measured by change in glycemic control.
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0 and 3 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Staff satisfaction
기간: 3 months
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Measure of hospital staff satisfaction of using the Health-e-Connect platform to help patients communicate with an endocrinologist
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3 months
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Frequency of Self-Monitoring
기간: 3 months
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Measure the frequency of blood glucose self-monitoring of the patients by collecting the total number of tests using the provided meter.
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3 months
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unplanned hospitalizations
기간: 3 months
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A secondary endpoint includes adverse events such as unplanned hospitalizations for any cause that last more than 24 hours
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3 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Hugh Tildesley, Providence Health Care, University of British Columbia
간행물 및 유용한 링크
일반 간행물
- Diabetes Control and Complications Trial Research Group, Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.
- Clement M and Leung F. Diabetes and the Frail Elderly in Long-term Care. Can J Diabetes. 2009;33(2):114-121.
- Austin MM, Haas L, Johnson T, Parkin CG, Parkin CL, Spollett G, Volpone MT. Self-monitoring of blood glucose: benefits and utilization. Diabetes Educ. 2006 Nov-Dec;32(6):835-6, 844-7. doi: 10.1177/0145721706295873. No abstract available.
- American Diabetes Association. Standards of medical care in diabetes--2008. Diabetes Care. 2008 Jan;31 Suppl 1:S12-54. doi: 10.2337/dc08-S012. No abstract available.
- Karter AJ, Ackerson LM, Darbinian JA, D'Agostino RB Jr, Ferrara A, Liu J, Selby JV. Self-monitoring of blood glucose levels and glycemic control: the Northern California Kaiser Permanente Diabetes registry. Am J Med. 2001 Jul;111(1):1-9. doi: 10.1016/s0002-9343(01)00742-2.
- Hirsch IB, Bode BW, Childs BP, Close KL, Fisher WA, Gavin JR, Ginsberg BH, Raine CH, Verderese CA. Self-Monitoring of Blood Glucose (SMBG) in insulin- and non-insulin-using adults with diabetes: consensus recommendations for improving SMBG accuracy, utilization, and research. Diabetes Technol Ther. 2008 Dec;10(6):419-39. doi: 10.1089/dia.2008.0104.
- Tildesley HD, Mazanderani, AB, Chan, JHM et al. Efficacy of A1c Reduction Using Internet Intervention in Patients with Type 2 Diabetes Treated with Insulin. Can J Diabetes. 2011; 35(3): 250-253.
연구 기록 날짜
연구 주요 날짜
연구 시작
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 (추정)
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. .
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