Back to resultsSimplified Insulin Regimen for the Elderly
Primary Purpose
Type 2 Diabetes Mellitus
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Insulin Glargine
Insulin Glargine
Insulin Aspart
Insulin Lispro
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Diabetes, Elderly, Insulin treatment, Quality of life
Eligibility Criteria
Inclusion Criteria:
-Age >65 years
Exclusion Criteria:
- Unable to provide informed consent
- Enrollment in another research study
- History of hypoglycemia unawareness
- Pregnant women
- Prisoners
Sites / Locations
- University of Miami
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Multiple Subcutaneous Injection (MSI)
Basal Insulin (BI)
Arm Description
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.
BI group will receive only one injection of insulin glargine in the morning.
Outcomes
Primary Outcome Measures
Hemoglobin A1c (HbA1c)
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
Average of home monitored blood glucose levels will be compared between the two groups
Incidence of any hypoglycemia
Defined as any reported blood glucose (BG) <70 mg/dl will be compared between the two groups
Incidence of severe hypoglycemia
Any BG <54 mg/dl or patient requiring assistance to recover from hypoglycemia will be compared between 2 groups.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03660553
Brief Title
Simplified Insulin Regimen for the Elderly
Official Title
Effect of Simplified Insulin Regimen on Glycemic Control and Quality of Life in an Elderly Population With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
PI left University of Miami
Study Start Date
October 10, 2018 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
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
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Diabetes, Elderly, Insulin treatment, Quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Multiple Subcutaneous Injection (MSI)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Basal Insulin (BI)
Arm Type
Experimental
Arm Description
BI group will receive only one injection of insulin glargine in the morning.
Intervention Type
Drug
Intervention Name(s)
Insulin Glargine
Intervention Description
0.40 units/kg body weight
Intervention Type
Drug
Intervention Name(s)
Insulin Glargine
Intervention Description
0.20 units/kg body weight
Intervention Type
Drug
Intervention Name(s)
Insulin Aspart
Intervention Description
0.20 units/kg body weight
Intervention Type
Drug
Intervention Name(s)
Insulin Lispro
Intervention Description
0.20 units/kg body weight
Primary Outcome Measure Information:
Title
Hemoglobin A1c (HbA1c)
Description
The mean HbA1c in the BI group will be compared to the mean HbA1c in the MSI group
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Average blood glucose levels
Description
Average of home monitored blood glucose levels will be compared between the two groups
Time Frame
6 months
Title
Incidence of any hypoglycemia
Description
Defined as any reported blood glucose (BG) <70 mg/dl will be compared between the two groups
Time Frame
6 months
Title
Incidence of severe hypoglycemia
Description
Any BG <54 mg/dl or patient requiring assistance to recover from hypoglycemia will be compared between 2 groups.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
-Age >65 years
Exclusion Criteria:
Unable to provide informed consent
Enrollment in another research study
History of hypoglycemia unawareness
Pregnant women
Prisoners
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rajesh Garg, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Simplified Insulin Regimen for the Elderly
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