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NCT04436822 · ClinicalTrials.gov registry record · NA
Evaluation of Updated Continuous Glucose Monitoring (CGM) Form Factor in Adults, Adolescents and Pediatrics
A NA study of Type 2 Diabetes Mellitus and Type 1 Diabetes Mellitus, sponsored by Medtronic Diabetes.
- Completed
- Registry status
- NA
- Development phase
- 317
- Enrollment target
- 18
- Study locations
NCT04436822: Completed NA study of Type 2 Diabetes Mellitus and Type 1 Diabetes Mellitus, sponsored by Medtronic Diabetes.
NCT04436822 is a NA study of Type 2 Diabetes Mellitus and Type 1 Diabetes Mellitus that has completed, run by Medtronic Diabetes. The registered enrollment target is 317 participants, below the 2,957-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (89% lower). The trial reports 18 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04436822, a NA study of Type 2 Diabetes Mellitus and Type 1 Diabetes Mellitus, has completed, sponsored by Medtronic Diabetes.
- COMPLETED
- Registry status
- NA
- Development phase
- 317 participants
- Enrollment target
- 18
- Study locations
Study Summary
The purpose of this study is to demonstrate the performance of the Disposable Sensor (DS5) in subjects age 2 - 80 years, for the span of 170 hours (7 days).
Primary Outcome
Mean of daily percentage of sensor values within 20% of Yellow Springs Instrument (YSI™\*) reference value (within 20 mg/dL \[1.1 mmol/L\] when sensor values \< 80 mg/dL) \[4.4 mmol/L\]) by age groups and DS5 insertion locations. Note Self-Monitoring Blood Glucose (SMBG) was used for age 2-6, instead of YSI. Zero calibration sensor algorithm applied to raw sensor data.
Conditions Studied
Interventions
- DEVICE Continuous Glucose Monitoring
Study Locations (18)
California
- AMCR Institute - Escondido
- Sansum Diabetes Research Institute - Santa Barbara
- SoCal Diabetes - Torrance
- Diablo Clinical Research, Inc. - Walnut Creek
Colorado
- Barbara Davis Center for Childhood Diabetes - Aurora
- Barbara Davis Center for Diabetes - Aurora
Shanghai Municipality
- Shanghai Sixth People's Hospital - Shanghai
- Children's Hospital of Fudan University - Shanghai
Florida
- University of South Florida - Tampa
Georgia
- Atlanta Diabetes Associates - Atlanta
Idaho
- Rocky Mountain Diabetes and Osteoporosis Center - Idaho Falls
Tennessee
- AM Diabetes and Endocrinology Center - Bartlett
Texas
- Texas Diabetes & Endocrinology - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 317 participants |
| Start Date | 2020-07-15 |
| Est. Completion | 2022-04-12 |
| Phase | NA |
What the finished NCT04436822 record still lists
NCT04436822 is an interventional study that assigns participants to a tested intervention. The registered 317 participants enrollment target is mid-sized for trials with a published cap, below the 2,957-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (89% lower).
The record links to 2 conditions, with Type 2 Diabetes Mellitus appearing as the primary indexed condition, and to 1 intervention - of which Continuous Glucose Monitoring is the first listed.
NCT04436822 lists 18 locations in 13 states (California, Colorado, Shanghai Municipality).
Frequently Asked Questions
What is clinical trial NCT04436822 about?
NCT04436822 is a clinical study titled "Evaluation of Updated Continuous Glucose Monitoring (CGM) Form Factor in Adults, Adolescents and Pediatrics". The purpose of this study is to demonstrate the performance of the Disposable Sensor (DS5) in subjects age 2 - 80 years, for the span of 170 hours (7 days).
What is the current status of trial NCT04436822?
This trial is currently completed. It is a NA study. The enrollment target is 317 participants. The study started on 2020-07-15. Estimated completion is 2022-04-12.
What conditions does trial NCT04436822 study?
This clinical trial studies the following conditions: Type 2 Diabetes Mellitus, Type 1 Diabetes Mellitus.
What interventions are being tested in trial NCT04436822?
The interventions under investigation include: Continuous Glucose Monitoring (DEVICE).
Who is sponsoring clinical trial NCT04436822?
This trial is sponsored by Medtronic Diabetes, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04436822 being conducted?
This trial has 18 study locations across California, Colorado, Florida, Georgia, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04436822's enrollment target sits among peer trials
317 26th of 130 higher than 105 of 130 other Type 2 Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 2 Diabetes Mellitus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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