Glucose Variability in Subclinical Hypertrophy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Glucose Variability in Subclinical Hypertrophy

Conditions
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Diabetes Mellitus, Lipohypertrophy

Intervention / Treatment
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* Other: Lipohypertrophy
* Other: Normal Subcutaneous Tissue


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Lipohypertrophy<br>Participants inject their insulin into the abdomen into areas of lipohypertrophy that were identified by ultrasound in Phase 1 of the study. | Other: Lipohypertrophy<br> <br> |
| Other: Normal Subcutaneous Tissue<br>Participants inject their insulin into the abdomen into areas with normal subcutaneous tissue. | Other: Normal Subcutaneous Tissue<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose levels | iPro2 Continuous Blood Glucose Monitor | Continuously for 12 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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iPro2 Continuous Blood Glucose Recorder, Subclinical