Simplified Insulin Protocol Using Lantus in Elderly

Diabetes Clinical Trial

— SIMPLE  

Official title:

Simplification of Diabetes Regimen in Elderly Patients Using Glargine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01480843
• Other study ID #: 2011-05
• Status: Completed
• Phase: Phase 4
• First received: November 9, 2011
• Last updated: October 9, 2017
• Start date: June 2011
• Est. completion date: September 2015

Study information

• Verified date: October 2017
• Source: Joslin Diabetes Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes

Intervention

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

Locations

Country	Name	City	State
United States	Joslin Diabetes Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Joslin Diabetes Center	Sanofi

Country where clinical trial is conducted

United States, 

References & Publications (24)

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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. — View Citation

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* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Duration of Hypoglycemia Episodes	duration of hypoglycemia measured by continuous glucose monitoring	baseline, 5 months, 8 months
Primary	Change in Frequency of Hypoglycemia Episodes From 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