Optimizing Insulin Absorption and Insulin Injection Technique in Older Adults

January 16, 2018 updated by: Graydon Meneilly, University of British Columbia

To determine which anatomic site offers the most consistent (superior) absorption of insulin.

To determine the injection technique which allows the most consistent subcutaneous injection of insulin (to pinch or to spread).

Hypothesis:

Based on age-related changes in the amount of subcutaneous fat we anticipate that the absorption of insulin from various anatomical sites will differ.

Justification:

To date health care professionals have extrapolated data obtained from younger adults and applied the results to the elderly.

Objectives:

To determine the rate of insulin absorption from different anatomic sites in diabetic patients over the age of 70.

To determine the best practice for subcutaneous injection in older adults.

Research Method:

Measurement of serial glucose and insulin levels using 360 minute euglycemic clamp studies.

Statistical Analysis:

Paired t test, repeated measures ANOVA

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will consist of 5 visits to the UBC VITALiTY Research Centre. At the screening visit subjects will have the following information collected: height, weight, blood pressure, heart rate, BMI, medical history and concommitant medications. Approximately 15cc of blood will be drawn and analyzed for A1C, CBC with platelets, AST, ALT, alk phos, BUN, creatinine, fasting blood sugar.

The subjects will undergo 4 euglycemic clamp studies at least 30 days apart in random order. During one study subjects will receive the insulin injection in the abdomen using the pinch technique. In another study the subjects will receive the insulin injection using the spread technique. During a third study the subjects will receive the insulin injection in the deltiod area using the pinch technique. During a fourth study the subjects will receive the insulin injection in the deltoid using the spread technique. Subjects will be randomly assigned to the studies. After each injection the subject will complete a questionnaire to rate comfort of the injection.

Subjects will report to the Research Centre at 0700 having fasted since midnight the night before. An intravenous line with normal saline will be placed in one hand to facilitate blood drawing. This hand will be placed in a heated box. A second intravenous will be inserted in the arm for the infusion of glucose.

Prior to subcutaneous insulin injection, blood samples will be collected at -30, -15, and 0 minutes. At time 0 the subcutaneous injection of lispro insulin (0.1 u/kg)will be administered and the glucose infusion will be started. Glucose levels will be measured at the bedside every 5 min and insulin levels every 15 min from 0-360 min. Glucose infusion will be adjusted to maintain glucose levels at a constant level for the duration of the study, using the glucose clamp protocol.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

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

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Vitality Research Centre - Vancouver General Hospital

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

70 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female over the age of 70
  • Type 2 diabetes
  • Insulin naive - never have taken insulin with the exception of a short course during a hospitalization or illness
  • A1C between .065-.085
  • BMI between 25 and 35

Exclusion Criteria:

  • hemoglobin below 130g/L (males) and below 120g/L (females)
  • taking medications that are known to interfere with glucose metabolism: systemic corticosteroids, non selective beta blockers
  • Impaired liver function as shown by but not limited to AST and/or ALT > 2 times the upper limit of normal
  • impaired renal function as shown by but not limited to serum creatinine > 133micromoles/L (males) and 124 micromoles/L (female)
  • participation in another clinical trial within the past 30 days

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: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1

Each patient will receive 2 insulin injections in the abdomen: Once using a pinch method and once using a spread method.

Injections will be given in a random order and the technician will be blinded to the injection.

Each patient will evaluate the comfort of the injection by completing a visual analog scale.
Procedure: Lispro insulin
Each patient will receive 2 insulin injections in the abdomen: Once using a pinch method and once using a spread method.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Anatomic site, abdomen versus deltoid, that offers the most consistent(superior) absorption of insulin

Secondary Outcome Measures

Outcome Measure
Injection technique which allows the most comfortable method of inserting the needle subcutaneously

Collaborators and Investigators

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

Sponsor

University of British Columbia

Investigators

  • Study Director: Gale Tedder, Vancouver Coastal Health Research Institute
  • Study Director: Chris Lockhart, Vancouver Coastal Health Research Institute
  • Study Director: Lee Ann Trimble, Vancouver Coastal Health Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2010

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

September 29, 2010

First Submitted That Met QC Criteria

September 30, 2010

First Posted (Estimate)

October 4, 2010

Study Record Updates

Last Update Posted (Actual)

January 18, 2018

Last Update Submitted That Met QC Criteria

January 16, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H10-00462

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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