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The study run its course
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This is a pilot study to enroll 100 people to assess the incidence of lipohypertrophy as detected with ultrasound and its impact on glycemic variability.
Lipohypertrophy is a well documented phenomenon in patients with diabetes in which hypertrophy and differentiation of adipocytes occurs in the dermal reticular layer at the sites of subcutaneous insulin injection. Currently, lipohypertrophy is assessed by palpating insulin injection sites. The detection on early, non palpable (subclinical) lipohypertrophy remains difficult in the clinical setting. Recent studies have identified distinct ultrasonographic features of hyperechogenicity in areas of adipose tissue consistent with clinical evidence of lipohypertrophy at insulin injection sites, and have detected changes int he thickness of subcutaneous tissue where not clinically evident in population of patients with type 1 diabetes. Lipohypertrophy can adversely affect glycemic control. Injecting into lipohypertrophic areas leads to poor absorption and the need for increasing doses of insulin.
In this study study participants will undergo an assessment for lipohypertrophy during a scheduled visit at the VGH Diabetes Centre. A Diabetes Nurse will assess lipohypertrophy by palpation according to the FIT Protocol. A second diabetes nurse who was not present at the palpation will assess insulin injection sites for lipohypertrophy by ultrasound using a linear probe.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound | Other | Abdomen scanned with portable ultrasound to determine presence of subclinical lipohypertrophy. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Presence of Subclinical Lipohypertrophy | Lipohypertrophy seen on ultrasound but not felt by palpation | Assessed one time only at the time of clinic visit |
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Inclusion Criteria:
Exclusion Criteria:
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People age 19 and over with type 1 or type 2 diabetes who take insulin to manage their diabetes.
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| Name | Affiliation | Role |
|---|---|---|
| Graydon Meneilly, MD | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vancouver General Hospital | Vancouver | British Columbia | V5Z 1M9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29908078 | Derived | Kapeluto JE, Paty BW, Chang SD, Meneilly GS. Ultrasound detection of insulin-induced lipohypertrophy in Type 1 and Type 2 diabetes. Diabet Med. 2018 Oct;35(10):1383-1390. doi: 10.1111/dme.13764. Epub 2018 Jul 16. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Diabetes Patients Treated With Insulin | We propose a pilot study in a minimum of 100 patients with diabetes who have been using insulin therapy for at least two years and being treated with insulin at the time of the study. Patients using insulin pumps, insulin secretagogues (e.g. sulfonylureas), GLP-1 agonists and immunosuppreressant agents will be excluded. Women who are pregnant will be excluded. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
This is a pilot study in a minimum of 100 patients with diabetes who have been using insulin therapy for at least two years and being treated with insulin at the time of the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Diabetes Patients Treated With Insulin | We propose a pilot study in a minimum of 100 patients with diabetes who have been using insulin therapy for at least two years and being treated with insulin at the time of the study. Patients using insulin pumps, insulin secretagogues (e.g. sulfonylureas), GLP-1 agonists and immunosuppreressant agents will be excluded. Women who are pregnant will be excluded. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Presence of Subclinical Lipohypertrophy | Lipohypertrophy seen on ultrasound but not felt by palpation | 100 participants were analyzed for having subclinical lipohypertophy. | Posted | Count of Participants | Participants | No | Assessed one time only at the time of clinic visit |
|
During study procedure within study visit up to 1 hour
All adverse events will be collected from the enrolled participants by the study staff
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Diabetes Patients Treated With Insulin | We propose a pilot study in a minimum of 100 patients with diabetes who have been using insulin therapy for at least two years and being treated with insulin at the time of the study. Patients using insulin pumps, insulin secretagogues (e.g. sulfonylureas), GLP-1 agonists and immunosuppreressant agents will be excluded. Women who are pregnant will be excluded. There may be some discomfort associated with the insertion of the glucose sensor. There is a small risk of skin infection from the insertion of the glucose sensor and catheter and the possibility of an allergic reaction from the tape used to apply it. This risk occurs less than 1 in 1000 times the sensor is used. If patients have concerns regarding insulin dose adjustments they will have access to a diabetes education and research nurse who can assist with insulin dose titration. Any additional adverse events will be monitored by a trained research nurse at the Diabetes Centre. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin infection | Skin and subcutaneous tissue disorders | Systematic Assessment | Skin infection from the insertion of the glucose sensor and catheter |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mr Boris Feldman, Research Associate | Gerontology Research Lab | 16048755115 | boris.feldman@vch.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 26, 2016 | Sep 19, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D019220 | High-Energy Shock Waves |
| ID | Term |
|---|---|
| D000069453 | Ultrasonic Waves |
| D013016 | Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
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| Participants |
| No |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Presence of Lipohypertrophy | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| 0 |
| 100 |
| 0 |
| 100 |
| 1 |
| 100 |
|
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| D055585 |
| Physical Phenomena |