Clinical trial NCT02748434: Glucose Variability in Subclinical Hypertrophy
Official title: Glucose Variability in Subclinical Hypertrophy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus
Lipohypertrophy
Keywords: iPro2 Continuous Blood Glucose Recorder
Subclinical
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2016-04-22
Enrollment: 9
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Blood glucose levels
timeFrame: Continuously for 12 days
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Gerontology Research Lab
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver General Hospital Diabetes Centre
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Graydon Meneilly, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: Jordanna Kapeluto, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: Breay Paty, MD
role: PRINCIPAL_INVESTIGATOR
References: