Glucose Variability in Subclinical Hypertrophy

Sponsor

University of British Columbia (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02748434

Collaborator

Medtronic (Industry)

Enrollment

Locations

Arms

Anticipated Duration (Months)

4.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus Lipohypertrophy	Other: Lipohypertrophy Other: Normal Subcutaneous Tissue	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

9 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Other

Official Title:

Glucose Variability in Subclinical Hypertrophy

Actual Study Start Date :

Oct 1, 2016

Actual Primary Completion Date :

Jan 1, 2021

Anticipated Study Completion Date :

Aug 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Blood glucose levels [Continuously for 12 days]
iPro2 Continuous Blood Glucose Monitor

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gerontology Research Lab	Vancouver	British Columbia	Canada	V5Z 1M9
2	Vancouver General Hospital Diabetes Centre	Vancouver	British Columbia	Canada	V5Z 1M9

Sponsors and Collaborators

University of British Columbia
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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Graydon Meneilly, Professor, UBC Department of Medicine, University of British Columbia

ClinicalTrials.gov Identifier:

NCT02748434

Other Study ID Numbers:

H16-01025

First Posted:

Apr 22, 2016

Last Update Posted:

Sep 28, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Graydon Meneilly, Professor, UBC Department of Medicine, University of British Columbia

iPro2 Continuous Blood Glucose Recorder

Subclinical

Additional relevant MeSH terms:

Hypertrophy

Study Results

No Results Posted as of Sep 28, 2021