Simplified Insulin Regimen for the Elderly

Sponsor

University of Miami (Other)

Overall Status

Terminated

CT.gov ID

NCT03660553

Collaborator

(none)

Enrollment

Location

Arms

44.6

Actual Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus	Drug: Insulin Glargine Drug: Insulin Glargine Drug: Insulin Aspart Drug: Insulin Lispro	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

7 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 10, 2018

Actual Primary Completion Date :

Jun 30, 2022

Actual Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Multiple Subcutaneous Injection (MSI) 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 0.20 units/kg body weight Drug: Insulin Aspart 0.20 units/kg body weight Drug: Insulin Lispro 0.20 units/kg body weight
Experimental: Basal Insulin (BI) BI group will receive only one injection of insulin glargine in the morning.	Drug: Insulin Glargine 0.40 units/kg body weight

Arm

Intervention/Treatment

Active Comparator: Multiple Subcutaneous Injection (MSI)

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

0.20 units/kg body weight

Drug: Insulin Aspart

0.20 units/kg body weight

Drug: Insulin Lispro

0.20 units/kg body weight

Experimental: Basal Insulin (BI)

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

Drug: Insulin Glargine

0.40 units/kg body weight

Outcome Measures

Primary Outcome Measures

Hemoglobin A1c (HbA1c) [6 months]
The mean HbA1c in the BI group will be compared to the mean HbA1c in the MSI group

Secondary Outcome Measures

Average blood glucose levels [6 months]
Average of home monitored blood glucose levels will be compared between the two groups
Incidence of any hypoglycemia [6 months]
Defined as any reported blood glucose (BG) <70 mg/dl will be compared between the two groups
Incidence of severe hypoglycemia [6 months]
Any BG <54 mg/dl or patient requiring assistance to recover from hypoglycemia will be compared between 2 groups.