Simplified Insulin Protocol Using Lantus in Elderly (SIMPLE)
2017年10月9日 更新者：Joslin Diabetes Center
Simplification of Diabetes Regimen in Elderly Patients Using Glargine
The purpose of this study is to find out if simplifying your diabetes treatment by decreasing number of insulin injections, with the help of a long acting insulin called glargine, can decrease the episodes of low blood glucose.
研究概览
详细说明
As patients with diabetes age, adverse social and medical problems may arise.
Because of these problems patients, even those managing their diabetes for many years, find it difficult to continue with complicated insulin schedules.
This may lead to errors in treatment and poor glucose control.
Simplification of treatment has been found to the decrease risk of low blood glucose, a very dangerous condition at this age.
In a previous study, the investigators found that simplifying treatment did not cause the blood sugars to rise out of control.
In this study, the investigators plan to simplify insulin treatment and monitor for low glucose episodes with help of a continuous glucose monitor and A1C (measure of average glucose control over 3 months).
The investigators will simplify the treatment by adding glucose lowering medications that you can take by mouth, in addition to the injection of long acting insulin called glargine.
研究类型
介入性
注册 (实际的)
65
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Massachusetts
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Boston、Massachusetts、美国、02215
- Joslin Diabetes Center
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
70年 及以上 (年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Age 70 years or older
- Diagnosis of diabetes mellitus Type II
- At least 2 (short-acting or mixed) insulin injections per day
- At least 1 episode of hypoglycemia (glucose value <70) on screening CGM
Exclusion Criteria:
- Patients with the following illnesses in the past 12 months Myocardial infarction Angina Coronary artery bypass grafting Percutaneous transluminal coronary angiography Cerebrovascular event (stroke, TIA)
- Active liver disease (history of cirrhosis or LFT > 3 times normal)
- On dialysis or with severe renal dysfunction (creatinine clearance <20 ml/min)
- Malignancy that limits life span to less than 18 months
- Patients seen in the geriatric clinic who already have simplified regimen as proposed in the study
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Glargine
We plan to add long acting insulin glargine with/without oral medications to the regimen in all patients.
|
Use of glargine with/without other glucose lowering agent to simplify insulin regimen in older adults
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Duration of Hypoglycemia Episodes
大体时间：baseline, 5 months, 8 months
|
duration of hypoglycemia measured by continuous glucose monitoring
|
baseline, 5 months, 8 months
|
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Change in Frequency of Hypoglycemia Episodes From Baseline, 5 Months, 8 Months
大体时间：baseline, 5 months, 8 months
|
frequency of hypoglycemia episodes measured by continuous glucose monitoring per 5 days of continuous glucose monitoring data
|
baseline, 5 months, 8 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Polonsky WH, Anderson BJ, Lohrer PA, Welch G, Jacobson AM, Aponte JE, Schwartz CE. Assessment of diabetes-related distress. Diabetes Care. 1995 Jun;18(6):754-60. doi: 10.2337/diacare.18.6.754.
- Kovatchev BP, Clarke WL, Breton M, Brayman K, McCall A. Quantifying temporal glucose variability in diabetes via continuous glucose monitoring: mathematical methods and clinical application. Diabetes Technol Ther. 2005 Dec;7(6):849-62. doi: 10.1089/dia.2005.7.849.
- Munshi M, Grande L, Hayes M, Ayres D, Suhl E, Capelson R, Lin S, Milberg W, Weinger K. Cognitive dysfunction is associated with poor diabetes control in older adults. Diabetes Care. 2006 Aug;29(8):1794-9. doi: 10.2337/dc06-0506.
- Blaum CS, Ofstedal MB, Langa KM, Wray LA. Functional status and health outcomes in older americans with diabetes mellitus. J Am Geriatr Soc. 2003 Jun;51(6):745-53. doi: 10.1046/j.1365-2389.2003.51256.x.
- Bertoni AG, Kirk JK, Goff DC Jr, Wagenknecht LE. Excess mortality related to diabetes mellitus in elderly Medicare beneficiaries. Ann Epidemiol. 2004 May;14(5):362-7. doi: 10.1016/j.annepidem.2003.09.004.
- Economic consequences of diabetes mellitus in the U.S. in 1997. American Diabetes Association. Diabetes Care. 1998 Feb;21(2):296-309. doi: 10.2337/diacare.21.2.296.
- Montorio I, Izal M. The Geriatric Depression Scale: a review of its development and utility. Int Psychogeriatr. 1996 Spring;8(1):103-12. doi: 10.1017/s1041610296002505.
- Welch G, Weinger K, Anderson B, Polonsky WH. Responsiveness of the Problem Areas In Diabetes (PAID) questionnaire. Diabet Med. 2003 Jan;20(1):69-72. doi: 10.1046/j.1464-5491.2003.00832.x.
- Desouza C, Salazar H, Cheong B, Murgo J, Fonseca V. Association of hypoglycemia and cardiac ischemia: a study based on continuous monitoring. Diabetes Care. 2003 May;26(5):1485-9. doi: 10.2337/diacare.26.5.1485.
- Jacobson AM, de Groot M, Samson JA. The evaluation of two measures of quality of life in patients with type I and type II diabetes. Diabetes Care. 1994 Apr;17(4):267-74. doi: 10.2337/diacare.17.4.267.
- Arbuthnott K, Frank J. Trail making test, part B as a measure of executive control: validation using a set-switching paradigm. J Clin Exp Neuropsychol. 2000 Aug;22(4):518-28. doi: 10.1076/1380-3395(200008)22:4;1-0;FT518.
- Weinger K, Butler HA, Welch GW, La Greca AM. Measuring diabetes self-care: a psychometric analysis of the Self-Care Inventory-Revised with adults. Diabetes Care. 2005 Jun;28(6):1346-52. doi: 10.2337/diacare.28.6.1346.
- Zammitt NN, Frier BM. Hypoglycemia in type 2 diabetes: pathophysiology, frequency, and effects of different treatment modalities. Diabetes Care. 2005 Dec;28(12):2948-61. doi: 10.2337/diacare.28.12.2948. No abstract available.
- Narayan KM, Boyle JP, Geiss LS, Saaddine JB, Thompson TJ. Impact of recent increase in incidence on future diabetes burden: U.S., 2005-2050. Diabetes Care. 2006 Sep;29(9):2114-6. doi: 10.2337/dc06-1136. No abstract available.
- Bonsignore P DL, Suhl E, Sternthal A, Giusti J, Munshi MN. Unrecognized Errors in Insulin Injection Techniques Are Frequent in Older Adults Even with Longer Duration of Insulin Use. In: American Diabetes Association annual meeting 2009; 2009; New Orleans LA; 2009. p. 913-P.
- Medha N. Munshi EB, Ramachandiran Cooppan. Diabetes in the Older Adult. In: Richard S. Beaser MatSoJDC, ed. Joslin's Diabetes Deskbook : A guide for primary care providers. 2nd ed. Boston: Joslin Diabetes Center; 2007:623-38.
- Shorr RI, Ray WA, Daugherty JR, Griffin MR. Incidence and risk factors for serious hypoglycemia in older persons using insulin or sulfonylureas. Arch Intern Med. 1997 Aug 11-25;157(15):1681-6.
- McAulay V FB. Hypoglycemia in diabetes in old age. In: Sinclair A, Finucane P, ed. 2nd ed. Chichester, UK: John wiley and sons; 2001:133-52.
- Frier BM. Hypoglycaemic valleys: an under-recognised problem in type 2 diabetes? Int J Clin Pract Suppl. 2002 Jul;(129):12-9.
- Ayres D SE, Capelson R, Weinger K, Munshi M. Identifying Barriers to Diabetes Education and Self-Care in Older Adults. In: American diabetes Association 65th scientific sessions 2005; San Diego CA; 2005. p. 941-P
- Munshi MN DL, Iwata I, Suhl E, Giusti J, Bonsignore P, Sternthal A The Risk of Hypoglycemia Is a Treatment-Limiting Factor in Older Adults Even with Poor Glycemic Control. In: American Diabetes Association annual meeting 2009; 2009; New Orleans LA; 2009. p. 2123-PO.
- Munshi MN, Hayes M, Sternthal A, Ayres D. Use of serum c-peptide level to simplify diabetes treatment regimens in older adults. Am J Med. 2009 Apr;122(4):395-7. doi: 10.1016/j.amjmed.2008.12.008.
- Hendriksen C, Faber OK, Drejer J, Binder C. Prevalence of residual B-cell function in insulin-treated diabetics evaluated by the plasma C-etide response to intravenous glucagon. Diabetologia. 1977 Dec;13(6):615-9. doi: 10.1007/BF01236316.
- Faber OK, Binder C. C-peptide response to glucagon. A test for the residual beta-cell function in diabetes mellitus. Diabetes. 1977 Jul;26(7):605-10. doi: 10.2337/diab.26.7.605.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年6月1日
初级完成 (实际的)
2015年9月1日
研究完成 (实际的)
2015年9月1日
研究注册日期
首次提交
2011年11月9日
首先提交符合 QC 标准的
2011年11月23日
首次发布 (估计)
2011年11月29日
研究记录更新
最后更新发布 (实际的)
2017年11月8日
上次提交的符合 QC 标准的更新
2017年10月9日
最后验证
2017年10月1日
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.