Simplified Insulin Protocol Using Lantus in Elderly

Study Overview
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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.

Official Title
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Simplification of Diabetes Regimen in Elderly Patients Using Glargine

Conditions
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Diabetes

Intervention / Treatment
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* Drug: Glargine


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glargine<br>We plan to add long acting insulin glargine with/without oral medications to the regimen in all patients. | Drug: Glargine<br>* Use of glargine with/without other glucose lowering agent to simplify insulin regimen in older adults<br>* Other names: Lantus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Duration of Hypoglycemia Episodes | duration of hypoglycemia measured by continuous glucose monitoring | baseline, 5 months, 8 months | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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simplification, glargine, elderly