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Simplified Insulin Protocol Using Lantus in Elderly

NCT ID: NCT01480843

Last Updated: 2017-11-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2015-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diabetes

Keywords

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simplification glargine elderly

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Glargine

We plan to add long acting insulin glargine with/without oral medications to the regimen in all patients.

Group Type EXPERIMENTAL

Glargine

Intervention Type DRUG

Use of glargine with/without other glucose lowering agent to simplify insulin regimen in older adults

Interventions

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Glargine

Use of glargine with/without other glucose lowering agent to simplify insulin regimen in older adults

Intervention Type DRUG

Other Intervention Names

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Lantus

Eligibility Criteria

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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
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role collaborator

Joslin Diabetes Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medha N Munshi, MD

Role: PRINCIPAL_INVESTIGATOR

Joslin Diabetes Center

Locations

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Joslin Diabetes Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 16306561 (View on PubMed)

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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 16873782 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 19332236 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16386091 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 338408 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 326604 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8805091 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10923061 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12519323 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7555499 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8026281 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15920050 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16936162 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9539999 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15177276 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12757559 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 9250229 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 12716809 (View on PubMed)

Frier BM. Hypoglycaemic valleys: an under-recognised problem in type 2 diabetes? Int J Clin Pract Suppl. 2002 Jul;(129):12-9.

Reference Type BACKGROUND
PMID: 12166599 (View on PubMed)

Other Identifiers

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2011-05

Identifier Type: -

Identifier Source: org_study_id