Simplified Insulin Regimen for the Elderly

Study Overview
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Brief Summary
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Basal-bolus insulin therapy, which includes one injection of long acting insulin and three injections of short acting insulin is the most commonly used insulin treatment. However, many older patients find the basal-bolus insulin regimen hard to manage because it involves 4 injections and 4 blood glucose tests each day. It is possible that a simplified treatment that involves one injection of long acting insulin daily and two blood glucose tests daily might be equally effective. This simplified regimen, if effective, would be easier to use and might result in less errors. Therefore, the investigators want to conduct this study to compare using a single daily injection of basal insulin with the usual basal-bolus insulin regimen in elderly patients (age >65 years) with type 2 diabetes.

Official Title
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Effect of Simplified Insulin Regimen on Glycemic Control and Quality of Life in an Elderly Population With Type 2 Diabetes

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Insulin Glargine
* Drug: Insulin Glargine
* Drug: Insulin Aspart
* Drug: Insulin Lispro


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -Age >65 years Exclusion Criteria: Unable to provide informed consent Enrollment in another research study History of hypoglycemia unawareness Pregnant women Prisoners

Ages Eligible for Study
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Minimum Age: 65 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Multiple Subcutaneous Injection (MSI)<br>MSI group will receive four insulin injections per day that will include a long acting and a short acting insulin. Short acting insulin will be either insulin aspart or insulin lispro. | Drug: Insulin Glargine<br>* 0.20 units/kg body weight<br>Drug: Insulin Aspart<br>* 0.20 units/kg body weight<br>Drug: Insulin Lispro<br>* 0.20 units/kg body weight<br>|
| Experimental: Basal Insulin (BI)<br>BI group will receive only one injection of insulin glargine in the morning. | Drug: Insulin Glargine<br>* 0.40 units/kg body weight<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c (HbA1c) | The mean HbA1c in the BI group will be compared to the mean HbA1c in the MSI group | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Any Hypoglycemia | Defined as any reported blood glucose (BG) <70 mg/dl will be compared between the two groups | 6 months | 
| Incidence of Severe Hypoglycemia | Any BG <54 mg/dl or patient requiring assistance to recover from hypoglycemia will be compared between 2 groups. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Elderly, Insulin treatment, Quality of life