NCT03660553

Simplified Insulin Regimen for the Elderly

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Insulin Glargine	0.40 units/kg body weight
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

Timeline

• Start date: 2018-10-10
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2018-09-06
• Last updated: 2023-12-12
• Results posted: 2023-12-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study