Simplified Insulin Regimen for the Elderly

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03660553
• Other study ID #: 20180541
• Status: Terminated
• Phase: Phase 4
• Start date: October 10, 2018
• Est. completion date: June 30, 2022

Study information

• Verified date: November 2023
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

-Age >65 years

Exclusion Criteria:

• Unable to provide informed consent

• Enrollment in another research study

• History of hypoglycemia unawareness

• Pregnant women

• Prisoners

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Insulin Glargine
0.40 units/kg body weight
• Insulin Glargine
0.20 units/kg body weight
• Insulin Aspart
0.20 units/kg body weight
• Insulin Lispro
0.20 units/kg body weight

Locations

Country	Name	City	State
United States	University of Miami	South Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1c (HbA1c)	The mean HbA1c in the BI group will be compared to the mean HbA1c in the MSI group	6 months
Secondary	Incidence of Any Hypoglycemia	Defined as any reported blood glucose (BG) <70 mg/dl will be compared between the two groups	6 months
Secondary	Incidence of Severe Hypoglycemia	Any BG <54 mg/dl or patient requiring assistance to recover from hypoglycemia will be compared between 2 groups.	6 months