Simplified Insulin Regimen for the Elderly

University of Miami

Status and phase: Terminated; Phase 4

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Insulin Aspart; Drug: Insulin Lispro; Drug: Insulin Glargine

Study type: Interventional

Funder types: Other

Identifiers

NCT03660553

20180541

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

-Age >65 years

Exclusion criteria

• Unable to provide informed consent
• Enrollment in another research study
• History of hypoglycemia unawareness
• Pregnant women
• Prisoners

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7 participants in 2 patient groups

Multiple Subcutaneous Injection (MSI)

Active Comparator group

Description:

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.

Treatment:

Drug: Insulin Lispro

Drug: Insulin Aspart

Drug: Insulin Glargine

Drug: Insulin Glargine

Basal Insulin (BI)

Experimental group

Description:

BI group will receive only one injection of insulin glargine in the morning.

Treatment:

Drug: Insulin Glargine

Drug: Insulin Glargine