Optimizing Insulin Absorption and Insulin Injection Technique in Older Adults

NCT01213901 | Completed

• 1 other identifier: H10-00462
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes

Keywords

Insulin absorption; Insulin injection technique

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Study Arms (1)

1

EXPERIMENTAL

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

Interventions

Lispro insulin PROCEDURE

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

1

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Vitality Research Centre - Vancouver General Hospital

Vancouver, British Columbia, Canada

Location

Related Publications (1)

• Trimble LA, Meneilly GS. Optimizing insulin absorption and insulin injection technique in older adults. Diabetes Care. 2014 Jun;37(6):e127-8. doi: 10.2337/dc14-0086. No abstract available.

  PMID: 24855165 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Insulin Lispro

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 29, 2010
• First Posted: October 4, 2010
• Study Start: September 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: March 1, 2014
• Last Updated: January 18, 2018

Record last verified: 2018-01

Locations

CA (1)