N/A
Completed N=6
Evaluating Use of Continuous Glucose Monitors in a Short-term 2x2-Crossover Study
Diabetes Type 2 · Diabetes
Source: ClinicalTrials.gov NCT04424888 ↗
Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcomePrimary: Temperature as a Source of Unwanted Variation When Using Freestyle Libre Glucose Sensors
Summary
This 5-week, double-blind, placebo-controlled, 2x2 crossover pilot study investigate the potential of collecting robust, real-time clinical study measures of glucose levels using Abbott Freestyle Libre Continuous Glucose Monitoring devices associated with a smartphone application
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Temperature as a Source of Unwanted Variation When Using Freestyle Libre Glucose Sensors |
— | — |
| PRIMARY 2-hour Interstitial Glucose Area Under the Curve (AUC) |
118.2167; 613.3667 | 0.21875 |
| SECONDARY Change in Body Mass |
-0.2; -1.72 | 0.90625 |
| SECONDARY Change in Fecal Quantitative PCR Measures of Probiotic Strain Concentration |
0.0000143; -0.00000194; 0.0000220; -0.00000286; 0; 0 | 0.020 sig |
| SECONDARY Expected Lifespan of Continuous Glucose Monitoring (CGM) Sensors |
3 | — |
| SECONDARY Number of Pictures Per Day |
5.85; 5.46 | 0.41 |
| SECONDARY Time Between CGM-sensor Scans |
2.91; 4.53 | 0.13 |
| SECONDARY CGM-Smartphone Usability Feedback |
8.25 | — |
Eligibility Criteria
Inclusion Criteria
- Age: 18 to 75 years of age
- If female, must meet all the following criteria:
- Not pregnant or breastfeeding
- If of childbearing potential (including peri-menopausal women who have had a menstrual period within one year) must practice and be willing to continue to practice appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year, when used consistently and correctly, such as double barrier methods [male condom with spermicide, with or without cervical cap or diaphragm], implants, injectable or oral contraceptives [must have been using for at least the last 3 months], some intrauterine contraceptive devices, tubal ligation, or in an established relationship with a vasectomized partner) during the entire duration of the study
- Must be able to read, understand, and sign the informed consent forms (ICF) and, when applicable, an authorization to use and disclose protected health information form (consistent with Health Insurance Portability and Accountability Act of 1996 [HIPAA] legislation as modified in 2013)
- Must be able to communicate with the investigator, and understand and comply with protocol requirements
- Must be able to wear a CG patch and perform a scan no less than once every 8 hours for the duration of the sensor periods.
Exclusion Criteria
- Subjects who plan to use antibiotic, antifungal, antiparasitic, or antiviral treatment during the study
- Subjects using a proton pump inhibitor must be on a stable dose that will be maintained throughout the study period
- Subjects who plan to travel outside the United States during the projected study period
- Subjects who have received an experimental drug within 30 days prior to study entry
- Subjects with known milk, peanut, or tree nut allergies
- Subjects who have been diagnosed with a sexually transmitted disease including, but not limited to, HIV, syphilis, herpes, gonorrhea, hepatitis A, hepatitis B, and hepatitis C
- History of any surgery on the gastrointestinal tract except appendectomy and cholecystectomy
- Subjects with any condition that the investigator deems as a sound reason for disqualification from enrollment into the study
Data sourced from ClinicalTrials.gov (NCT04424888). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.