Assessment of Mealtime Bolus Insulin Behavior
Status: | Completed |
---|---|
Conditions: | Diabetes, Diabetes, Diabetes |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 21 - 65 |
Updated: | 8/1/2018 |
Start Date: | December 11, 2017 |
End Date: | July 23, 2018 |
An Objective Assessment of Mealtime Bolus Insulin Behavior and Associated Factors
The main purpose of this study is to estimate missed bolus insulin doses in diabetics. This
is a 12-week, single-arm, outpatient, exploratory study with two study periods in Type 1 or
Type 2 diabetics, with an investigational reusable injection pen, insulin, and a Continuous
Glucose Monitoring (CGM) device.
is a 12-week, single-arm, outpatient, exploratory study with two study periods in Type 1 or
Type 2 diabetics, with an investigational reusable injection pen, insulin, and a Continuous
Glucose Monitoring (CGM) device.
Inclusion Criteria:
- Have a Type 1 Diabetes Mellitus (T1D) or a Type 2 Diabetes Mellitus (T2D) diagnosis
- Must be taking a mealtime bolus dose insulin, greater than or equal to (≥) 3 doses
- Each individual bolus insulin dose must be less than (<) 40 units
- Must be taking a stable insulin dose regimen for the last 3 months
- Must be taking a bolus insulin analog (for example insulin lispro [U-100]/[U-200],
insulin aspart, or insulin glulisine). In addition, must be able to switch to insulin
lispro U-100 for the duration of the trial
- Must have a hemoglobin A1c (HbA1c) ≥8.0% in the last 6 months
- Participants with T1D must be ≥21 to less than or equal to (≤) 65 years of age.
Participants with T2D must be ≥35 to ≤65 years of age
- Women of childbearing potential must meet the following: (Note: females of
childbearing potential are defined as those who have experienced menarche and who are
NOT permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive
months with no menses without an alternative medical cause)
- Must agree to use 1 highly effective method of contraception, or a combination of
2 effective methods of contraception for the entirety of the study
- Must test negative for pregnancy as indicated by a negative serum or urine
pregnancy test
- Participants with prior CGM/flash glucose monitoring experience must have stopped
CGM/flash glucose monitoring ≥3 months prior to enrollment
Exclusion Criteria:
- Have known tape/adhesive allergies with CGM sensors
- Medical conditions, visual, physical, psychiatric, or cognitive impairment(s) that may
preclude the ability to participate in the trial
- Have history of liver disease, acute or chronic hepatitis, or alanine aminotransferase
or aspartate aminotransferase levels ≥3 times the upper limit of the reference range
within the last 6 months
- Have history of chronic kidney disease stage 4 and higher within the last 6 months, or
history of renal transplantation
- Have active malignancy
- Are pregnant or planning to become pregnant
- Are on or are intending to begin a weight loss program
- Participants with T1D who have taken off-label antihyperglycemic agents within last 3
months
- Have received insulin by continuous subcutaneous insulin infusion in the last 3 months
- Participants taking opioid medications for medically invalid reasons or at doses
considered excessive
- Participants on routine use of acetaminophen
- Currently undergoing systemic treatment with:
- Immunosuppressive medication
- Chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding
topical and inhaled preparations) or have received such therapy within the prior
2 weeks
- Are currently enrolled in any other clinical study involving an investigational
product or any other type of medical research judged not to be scientifically or
medically compatible with this study
- Have participated, within the last 30 days, in a clinical study involving an
investigational product
- Are unwilling or unable to comply with the use of a data collection device to directly
record data
We found this trial at
6
sites
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Idaho Falls, Idaho 83404
Principal Investigator: David Liljenquist
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12121 Bluff Creek Drive
Los Angeles, California 90045
Los Angeles, California 90045
Principal Investigator: Henry Anhalt
Phone: 201-370-3690
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Ventura, California 93003
Principal Investigator: R H Chochinov
Phone: 805-658-8460
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1031 Office Park Road
West Des Moines, Iowa 50265
West Des Moines, Iowa 50265
Principal Investigator: Anuj Bhargava
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