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Simplified Insulin Protocol Using Lantus in Elderly

Information source: Joslin Diabetes Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes

Intervention: Glargine (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Joslin Diabetes Center

Official(s) and/or principal investigator(s):
Medha N Munshi, MD, Principal Investigator, Affiliation: Joslin Diabetes Center

Summary

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.

Clinical Details

Official title: Simplification of Diabetes Regimen in Elderly Patients Using Glargine

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change in frequency and duration of hypoglycemia episodes

Detailed description: 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.

Eligibility

Minimum age: 70 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Joslin Diabetes Center, Boston, Massachusetts 02215, United States
Additional Information

Related publications:

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Starting date: June 2011
Last updated: March 30, 2015

Page last updated: August 23, 2015

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