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Trial record 1 of 1 for:    NCT02748434
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Glucose Variability in Subclinical Hypertrophy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02748434
Recruitment Status : Unknown
Verified January 2018 by Graydon Meneilly, University of British Columbia.
Recruitment status was:  Recruiting
First Posted : April 22, 2016
Last Update Posted : January 18, 2018
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Graydon Meneilly, 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Lipohypertrophy Other: Lipohypertrophy Other: Normal Subcutaneous Tissue Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 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 : October 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Arm Intervention/treatment
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
Normal Subcutaneous Tissue
Participants inject their insulin into the abdomen into areas with normal subcutaneous tissue.
Other: Normal Subcutaneous Tissue



Primary Outcome Measures :
  1. Blood glucose levels [ Time Frame: Continuously for 12 days ]
    iPro2 Continuous Blood Glucose Monitor



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02748434


Contacts
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Contact: Boris Feldman 604-875-5115 boris.feldman@vch.ca

Locations
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Canada, British Columbia
Gerontology Research Lab Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Boris Feldman    604-875-5115    boris.feldman@vch.ca   
Principal Investigator: Graydon S Meneilly, MD         
Vancouver General Hospital Diabetes Centre Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Boris Feldman    604-875-5115    boris.feldman@vch.ca   
Principal Investigator: Graydon S Meneilly, MD         
Sponsors and Collaborators
University of British Columbia
Medtronic
Investigators
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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

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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: April 22, 2016    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Graydon Meneilly, University of British Columbia:
iPro2 Continuous Blood Glucose Recorder
Subclinical
Additional relevant MeSH terms:
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Hypertrophy
Pathological Conditions, Anatomical