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Simplified Insulin Regimen for the Elderly

NCT ID: NCT03660553

Last Updated: 2023-12-12

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-10

Study Completion Date

2022-06-30

Brief Summary

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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

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Conditions

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Type 2 Diabetes Mellitus

Keywords

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Diabetes Elderly Insulin treatment Quality of life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Insulin Glargine

Intervention Type DRUG

0.20 units/kg body weight

Insulin Aspart

Intervention Type DRUG

0.20 units/kg body weight

Insulin Lispro

Intervention Type DRUG

0.20 units/kg body weight

Basal Insulin (BI)

BI group will receive only one injection of insulin glargine in the morning.

Group Type EXPERIMENTAL

Insulin Glargine

Intervention Type DRUG

0.40 units/kg body weight

Interventions

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Insulin Glargine

0.40 units/kg body weight

Intervention Type DRUG

Insulin Glargine

0.20 units/kg body weight

Intervention Type DRUG

Insulin Aspart

0.20 units/kg body weight

Intervention Type DRUG

Insulin Lispro

0.20 units/kg body weight

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

-Age \>65 years

Exclusion Criteria

* Unable to provide informed consent
* Enrollment in another research study
* History of hypoglycemia unawareness
* Pregnant women
* Prisoners
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Rajesh Garg

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rajesh Garg, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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University of Miami

South Miami, Florida, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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20180541

Identifier Type: -

Identifier Source: org_study_id