Glucose Variability in Subclinical Hypertrophy

Not Applicable

Active, not recruiting

• Conditions: Diabetes Mellitus; Lipohypertrophy

• Registration Number: NCT02748434
• Lead Sponsor: University of British Columbia

Brief Summary

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.

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 Timeline

• Study First Submitted: 2016-04-20
• Study First Submitted QC: 2016-04-21
• Study First Posted: 2016-04-22
• Study Start: 2016-10
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-08
• Primary Completion: 2025-06
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 9

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Blood glucose levels	Continuously for 12 days	iPro2 Continuous Blood Glucose Monitor

Trial Locations

Locations (2)

Gerontology Research Lab; 🇨🇦 Vancouver, British Columbia, Canada

Vancouver General Hospital Diabetes Centre; 🇨🇦 Vancouver, British Columbia, Canada