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The purpose of this study is to examine the effect CGM (continuous glucose monitoring) has on subjects with type 2 diabetes. It is anticipated that patients using the device will obtain tighter control of their blood sugars resulting in measureable health benefits and improved confidence in their ability to manage their diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Basal insulin, approved oral medications |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in HgbA1c | Measured at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Time Spent at Glycemic Levels <65 mg/dl | Measured at baseline and at 6 months | |
| Change in Percentage of Time Spent at Glycemic Levels >180 mg/dl | Measured at baseline and 6 months | |
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Inclusion Criteria:
Exclusion Criteria
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Subjects of all adult ages (18 and older) with type 2 diabetes.
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| Name | Affiliation | Role |
|---|---|---|
| David R. Liljenquist, MD | Rocky Mountain Diabetes and Osteoporosis Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rocky Mountain Diabetes and Osteoporosis Center | Idaho Falls | Idaho | 83404 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Basal Insulin, Approved Oral Medications | Basal insulin, with or without approved oral agents |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Basal Insulin, Approved Oral Medications | Basal insulin, with or without approved oral agents |
| 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 | Change in HgbA1c | Posted | Mean | Standard Deviation | percentage of glycosylated hemoglobin | Measured at 6 months |
|
|
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0 serious adverse events were recorded. 3 device related adverse events were recorded.
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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 | Basal Insulin, Approved Oral Medications | Basal insulin, with or without approved oral agents |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Insertion site irritation | Skin and subcutaneous tissue disorders | Includes mild irritation at the site of insertion that has been deemed to be device related by the Primary Investigator. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Sulik, PharmD CCRP | Rocky Mountain Diabetes and Osteoporosis Center | 208-528-9642 | mark@idahomed.com |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Change in Basal Insulin Dose From Baseline Values |
| Assessed at baseline and 6 months |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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| Secondary | Percentage of Time Spent at Glycemic Levels <65 mg/dl | Posted | Mean | Standard Deviation | percentage of time spent < 65 mg/dl | Measured at baseline and at 6 months |
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| Secondary | Change in Percentage of Time Spent at Glycemic Levels >180 mg/dl | Posted | Mean | Standard Deviation | percentage of time spent >180 mg/dl | Measured at baseline and 6 months |
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| Secondary | Change in Basal Insulin Dose From Baseline Values | Posted | Mean | Standard Deviation | units of insulin | Assessed at baseline and 6 months |
|
|
|
| 0 |
| 30 |
| 3 |
| 30 |
|
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| D004700 | Endocrine System Diseases |