Effect of Internet Therapeutic Intervention on A1C Levels in Type 2 Diabetes Mellitus (DM) on Monotherapy
Effect of Internet Therapeutic Intervention on A1C Levels in Type 2 Diabetes Mellitus on Monotherapy
研究概览
详细说明
Purpose: To determine whether use of an Internet-based glucose monitoring system (ALR Technologies Inc.) improves Hemoglobin A1c (HbA1c) levels in patients with type 2 diabetes mellitus treated with only 1 oral anti-diabetic medication.
Hypothesis: The investigators propose that the standardized encounters using the Internet will improve the outcome of treatment for patients with type 2 DM.
Justification: An important aspect of diabetes care is the self-monitoring of blood glucose (SMBG) levels in order to assess the effectiveness of treatment and to modify the treatment to achieve the desirable glucose levels. All patients with type 2 DM are recommended to perform SMBG. However, it often requires intervention by health professionals in order to prevent the immediate and serious complications of hyper or hypoglycemia. The frequent SMBG and effective interventions by the health professionals may eventually allow tighter control of blood glucose levels and delay or prevent the complications associated with diabetes.
Objectives: The investigators propose to measure HbA1c levels at the beginning of the study and compare this with HbA1c levels at three and six months after initiating Internet-based blood glucose monitoring system (IBMS).
Research Method: Fifty patients will be randomized equally (a 50/50 chance) to either conventional therapy or the use of the Internet blood glucose monitoring system.
Conventional therapy (Control group) will consist of general care comprising of SMBG 3 or more times per day and visits to the endocrinologist at 3-month intervals with HbA1c, cholesterols, and serum creatinine determinations at 3-month intervals for 6 months.
Those patients randomized to the Internet system (Intervention group) will be required to perform SMBG 3 or more times per day and to upload their metered glucose values online every 2 weeks to be reviewed by the doctor. As well, there will be visits to the endocrinologist every 3 months with HbA1c, cholesterols, and serum creatinine measurements at 3-month intervals for 6 months.
Statistical Analysis: The primary endpoint is the HbA1c level or the change in A1c level. The secondary endpoints include severe hypoglycemia defined as requiring external aid, hospital admissions for any CVD related intervention, and adverse events such as unplanned hospitalizations for any cause that last more than 24 hours. For each group, A1C levels before the start of study will be compared to A1C levels 3 and 6 months after the start of the study. Paired t-tests and random effects models (longitudinal analyses) will examine differences in A1C values before and after the study duration. Unpaired, independent t-tests will be done to examine the difference in A1C values between the two groups before and after the interventions. Planned sample size is 50.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
-
-
British Columbia
-
Vancouver、British Columbia、加拿大
- St. Paul's Hospital
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Type 2 diabetes patients treated with only 1 oral anti-diabetic medication
- A1C 7-11%
- >25 years of age
- Willingness to test blood glucose levels a minimum of 3 times daily
- Willingness to be randomized
- Trained in self blood glucose monitoring
- Internet Access
Exclusion Criteria:
- Patients who do not meet the inclusion criteria or are not willing to participate will not be included in the study.
- In addition patients with the potential to become pregnant or patients using medications known to influence control of diabetes (eg steroids systemic or inhaled) are excluded from the study.
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:互联网干预
参加互联网治疗干预组的受试者接受标准护理,每天至少检测 3 次血糖,并每 3 个月拜访内分泌学家;但是,他们还被要求每两周将他们的血糖读数在线上传一次,以供健康从业者查看和评论。
|
参加互联网治疗干预组的受试者接受标准护理,每天至少检测 3 次血糖,并每 3 个月拜访内分泌学家;但是,他们还被要求每 2 周将他们的血糖读数在线上传一次,以供健康从业者查看和评论。
其他名称:
|
无干预:标准护理
这只手臂将接受标准护理,包括每天至少 3 次自我血糖监测和至少每 3 个月访问一次内分泌专家。
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
主要终点是 A1c 水平或 A1c 水平的变化
大体时间:6个月
|
6个月
|
次要结果测量
结果测量 |
大体时间 |
---|---|
次要终点包括定义为需要外部帮助的严重低血糖、因任何 CVD 相关干预而入院以及不良事件,例如持续超过 24 小时的任何原因的计划外住院
大体时间:6个月
|
6个月
|
合作者和调查者
调查人员
- 首席研究员:Hugh D Tildesley, MD、Providence Health Care, University of British Columbia
出版物和有用的链接
一般刊物
- 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.
- Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12;352(9131):837-53. Erratum In: Lancet 1999 Aug 14;354(9178):602.
- Nathan DM, Cleary PA, Backlund JY, Genuth SM, Lachin JM, Orchard TJ, Raskin P, Zinman B; Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study Research Group. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med. 2005 Dec 22;353(25):2643-53. doi: 10.1056/NEJMoa052187.
- Klonoff DC, Bergenstal R, Blonde L, Boren SA, Church TS, Gaffaney J, Jovanovic L, Kendall DM, Kollman C, Kovatchev BP, Leippert C, Owens DR, Polonsky WH, Reach G, Renard E, Riddell MC, Rubin RR, Schnell O, Siminiero LM, Vigersky RA, Wilson DM, Wollitzer AO. Consensus report of the coalition for clinical research-self-monitoring of blood glucose. J Diabetes Sci Technol. 2008 Nov;2(6):1030-53. doi: 10.1177/193229680800200612.
研究记录日期
研究主要日期
学习开始
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
互联网干预的临床试验
-
University of Wisconsin, MadisonNational Cancer Institute (NCI); Northwestern University主动,不招人
-
University of Illinois at ChicagoShirley Ryan AbilityLab; Oakland University; Access Living主动,不招人
-
University of Alabama at BirminghamNational Institute on Aging (NIA)终止