Glucose Variability in Subclinical Hypertrophy

Evaluation of insulin absorption at sites affected by clinically apparent lipohypertrophy through short-term continuous glucose monitoring has shown inconsistent results and it is yet unknown how or if subclinical lipohypertrophy affects absorption. In this study investigators propose to enroll at least 20 people who participated in phase 1 and who were determined to have subclinical lipohypertrophy to examine the correlation between glycemic control and amount of insulin injected in subclinical hypertrophic areas using capillary blood glucose and continuous glucose monitoring.

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetes Mellitus; Lipohypertrophy
• Intervention / Treatment: Other: Lipohypertrophy; Other: Normal Subcutaneous Tissue

Detailed Description

Patients will be randomized and data interpreters will be blinded to two alternating six-day protocols where the patients will be advised verbally and by written instruction to inject insulin in sites of subclinical lipohypertrophy or normal subcutaneous tissue. Patients will be asked to monitor and record their capillary blood glucose with meals and prior to bedtime using their own capillary blood glucose monitor. A trained research nurse at the Diabetes Centre will instrument each patient with an iPro 2 glucose sensor (Medtronic Canada). These sensors continuously measure blood glucose for periods of up to 7 days. A trained nurse will clean the skin with a superficial disinfectant and a small catheter will be inserted in the subcutaneous tissue at a non-lipohypertrophic site. The catheter will then be attached to a glucose sensor. Patients will wear this sensor for two periods of 6 days each at different sites. At the end of each of the two six day periods, the sensor will be removed.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Gerontology Research Lab
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Vancouver General Hospital Diabetes Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participation in phase 1
• Type 1 or Type 2 diabetes for at least 2 years
• Using insulin to manage diabetes
• At least 19 years of age

Exclusion Criteria:

• Taking insulin secretagogues (gliclazide, glyburide, glipizide
• Taking other injectable diabetes medications (i.e. liraglutide, Victoza)
• Taking systemic steroids (e.g. prednisone)
• Not fluent in speaking and writing English (unless accompanied by a translator)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Lipohypertrophy; Participants inject their insulin into the abdomen into areas of lipohypertrophy that were identified by ultrasound in Phase 1 of the study.	Other: Lipohypertrophy
Other: Normal Subcutaneous Tissue; Participants inject their insulin into the abdomen into areas with normal subcutaneous tissue.	Other: Normal Subcutaneous Tissue

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood glucose levels	iPro2 Continuous Blood Glucose Monitor	Continuously for 12 days

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Medtronic
• Investigators: Principal Investigator: Graydon Meneilly, MD, University of British Columbia; Principal Investigator: Jordanna Kapeluto, MD, University of British Columbia; Principal Investigator: Breay Paty, MD, University of British Columbia

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): May 1, 2024

Study Registration Dates

• First Submitted: April 20, 2016
• First Submitted That Met QC Criteria: April 21, 2016
• First Posted (Estimate): April 22, 2016

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Subclinical; iPro2 Continuous Blood Glucose Recorder
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hypertrophy
• Other Study ID Numbers: H16-01025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No