Glucose Variability in Subclinical Hypertrophy

Diabetes Mellitus Clinical Trial

Official title:

Glucose Variability in Subclinical Hypertrophy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02748434
• Other study ID #: H16-01025
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2016
• Est. completion date: September 1, 2025

Study information

• Verified date: May 2024
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 9
• Est. completion date: September 1, 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Hypertrophy
• Lipohypertrophy

Intervention

Other:
• Lipohypertrophy

• Normal Subcutaneous Tissue

Locations

Country	Name	City	State
Canada	Gerontology Research Lab	Vancouver	British Columbia
Canada	Vancouver General Hospital Diabetes Centre	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Medtronic

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood glucose levels	iPro2 Continuous Blood Glucose Monitor	Continuously for 12 days