Simplified Insulin Regimen for the Elderly

Phase 4

Terminated

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Insulin Glargine; Drug: Insulin Aspart; Drug: Insulin Lispro

• Registration Number: NCT03660553
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-04
• Study First Submitted QC: 2018-09-04
• Study First Posted: 2018-09-06
• Study Start: 2018-10-10
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Results First Submitted: 2023-07-18
• Status Verified: 2023-11
• Results First Submitted QC: 2023-11-20
• Last Update Submitted: 2023-11-20
• Results First Posted: 2023-12-12
• Last Update Posted: 2023-12-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

-Age >65 years

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multiple Subcutaneous Injection (MSI)	Insulin Lispro	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.
Basal Insulin (BI)	Insulin Glargine	BI group will receive only one injection of insulin glargine in the morning.
Multiple Subcutaneous Injection (MSI)	Insulin Glargine	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.
Multiple Subcutaneous Injection (MSI)	Insulin Aspart	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 South Miami, Florida, United States