Simplified Insulin Regimen for the Elderly

November 20, 2023 updated by: Rajesh Garg, University of Miami

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • South Miami, Florida, United States, 33143
        • University of Miami

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
0.40 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
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
Drug: Insulin Glargine
0.20 units/kg body weight

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin A1c (HbA1c)
Time Frame: 6 months
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
Time Frame: 6 months
Defined as any reported blood glucose (BG) <70 mg/dl will be compared between the two groups
6 months
Incidence of Severe Hypoglycemia
Time Frame: 6 months
Any BG <54 mg/dl or patient requiring assistance to recover from hypoglycemia will be compared between 2 groups.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Investigators

  • Principal Investigator: Rajesh Garg, MD, University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2018

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

September 4, 2018

First Submitted That Met QC Criteria

September 4, 2018

First Posted (Actual)

September 6, 2018

Study Record Updates

Last Update Posted (Actual)

December 12, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20180541

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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