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出境医 / 临床实验 / Feasibility Study of New Subcutaneous Glucose Sensor With Recording Devices
Feasibility Study of New Subcutaneous Glucose Sensor With Recording Devices
Study Description
Brief Summary:
The purpose of Phase 3 Group is to evaluate the impact of acetaminophen on the performance of Guardian Sensor (3) during 11 days of wear (approximately 264 hours) in subjects with insulin requiring diabetes,18-75 years of age.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Type 1 Diabetes Type 2 Diabetes | Device: Guardian Sensor (3) | Not Applicable |
Detailed Description:
The study is a multi-center, prospective single-arm design without controls. All subjects will be assigned to treatment for 11 days of sensor wear. Each subject will wear 4 Guardian Sensor (3)s, and each will be connected to a Guardian Link (3) Transmitter and/or Guardian Connect Transmitter. Subjects will not use sensor glucose values for diabetes management.
On days 1, 3, 5, and 6, subjects will be asked to measure blood glucose (BG) using a home glucose meter approximately every 20 minutes for 5 hours. Subjects will be asked to take one gram of acetaminophen orally on days 3, 5, and 6 of sensor wear.
On day 11, devices will be removed, data uploaded from the study meter and transmitter or recorder, skin assessment will be performed, and the subject's participation in the study will be completed.
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 19 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Other |
| Official Title: | Feasibility Study of New Subcutaneous Glucose Sensor With Recording Devices - Phase 3 Group |
| Actual Study Start Date : | July 29, 2019 |
| Actual Primary Completion Date : | August 27, 2019 |
| Actual Study Completion Date : | August 27, 2019 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Subjects Wearing Guardian Sensor (3)s
Each subject will wear 4 Guardian Sensor (3)s connected to a Guardian Link (3) Transmitter and/or Guardian Connect Transmitter for 11 days of sensor wear.
|
Device: Guardian Sensor (3)
Guardian Sensor (3) connected to Guardian Link (3) Transmitter and/or Guardian Connect Transmitter.
|
Outcome Measures
Primary Outcome Measures :
- Accuracy of Sensor Glucose Before and After Acetaminophen Administration [ Time Frame: Assessed up to 11 days, frequent sample testing recordings from the three-hour period leading to and after Acetaminophen ingestion on days 3, 5, and 6 reported ]
Accuracy (mean absolute relative difference) between the primary sensor values and meter BG values during the hour leading to and two hours after ingestion of acetaminophen. Primary sensor will be assigned to sensor number one (inserted in arm).
Mean Absolute Relative Difference = Mean of ((absolute difference of meter and sensor blood glucose values / meter glucose values) * 100).
Note that the results reported below for one hour leading to and two hours after acetaminophen ingestion were pooled together across multiple testing days (days 3, 5, and 6).
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subject is 18-75 years of age at time of screening
- A clinical diagnosis of type 1 or type 2 diabetes as determined by investigator, for at least the last 12 months
- Subject is using insulin to treat their diabetes
- Subject agrees to comply with the study protocol requirements
- Subject is willing to perform self-monitoring of blood glucose approximately every 20 minutes during FST
Exclusion Criteria:
- Subject has history of allergy to acetaminophen or has been told by health care provider they may not ingest acetaminophen
- Subject reports history of liver cirrhosis or problems with liver that a health care provider told them they should not use acetaminophen because of liver disorder.
- Subject is unable to tolerate tape adhesive in the area of sensor placement
- Subject has any unresolved adverse skin condition in the area of sensor or device placement (e.g. psoriasis, rash, Staphylococcus infection)
- Subject is actively participating in or plans to enroll in an investigational study (drug or device), other than this study, wherein they have received treatment from an investigational drug or device
- Subject has a positive urine pregnancy test at time of screening
- Subject is female, sexually active without the use of contraception, able to become pregnant or plans to become pregnant during the course of the study
- Subject is unwilling to participate in study procedures.
Contacts and Locations
Locations
| United States, Colorado | |
| Barbara Davis Center for Diabetes | |
| Aurora, Colorado, United States, 80045 | |
| United States, Georgia | |
| Atlanta Diabetes Associates | |
| Atlanta, Georgia, United States, 30318 | |
Sponsors and Collaborators
Medtronic Diabetes
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 12, 2019 | ||||||
| First Posted Date ICMJE | July 16, 2019 | ||||||
| Results First Submitted Date ICMJE | August 5, 2020 | ||||||
| Results First Posted Date ICMJE | September 16, 2020 | ||||||
| Last Update Posted Date | September 16, 2020 | ||||||
| Actual Study Start Date ICMJE | July 29, 2019 | ||||||
| Actual Primary Completion Date | August 27, 2019 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
Accuracy of Sensor Glucose Before and After Acetaminophen Administration [ Time Frame: Assessed up to 11 days, frequent sample testing recordings from the three-hour period leading to and after Acetaminophen ingestion on days 3, 5, and 6 reported ] Accuracy (mean absolute relative difference) between the primary sensor values and meter BG values during the hour leading to and two hours after ingestion of acetaminophen. Primary sensor will be assigned to sensor number one (inserted in arm).
Mean Absolute Relative Difference = Mean of ((absolute difference of meter and sensor blood glucose values / meter glucose values) * 100).
Note that the results reported below for one hour leading to and two hours after acetaminophen ingestion were pooled together across multiple testing days (days 3, 5, and 6).
|
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| Original Primary Outcome Measures ICMJE |
Accuracy of Sensor Glucose After Acetaminophen Administration [ Time Frame: 6 days ] Accuracy (mean absolute relative difference) between the primary sensor values and meter BG values during the two hours [approximately 6 paired points per frequent sample testing event (FST)] after ingestion of acetaminophen. Primary sensor will be assigned to sensor number one (inserted in arm).
|
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| Change History | |||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | Feasibility Study of New Subcutaneous Glucose Sensor With Recording Devices | ||||||
| Official Title ICMJE | Feasibility Study of New Subcutaneous Glucose Sensor With Recording Devices - Phase 3 Group | ||||||
| Brief Summary | The purpose of Phase 3 Group is to evaluate the impact of acetaminophen on the performance of Guardian Sensor (3) during 11 days of wear (approximately 264 hours) in subjects with insulin requiring diabetes,18-75 years of age. | ||||||
| Detailed Description |
The study is a multi-center, prospective single-arm design without controls. All subjects will be assigned to treatment for 11 days of sensor wear. Each subject will wear 4 Guardian Sensor (3)s, and each will be connected to a Guardian Link (3) Transmitter and/or Guardian Connect Transmitter. Subjects will not use sensor glucose values for diabetes management. On days 1, 3, 5, and 6, subjects will be asked to measure blood glucose (BG) using a home glucose meter approximately every 20 minutes for 5 hours. Subjects will be asked to take one gram of acetaminophen orally on days 3, 5, and 6 of sensor wear. On day 11, devices will be removed, data uploaded from the study meter and transmitter or recorder, skin assessment will be performed, and the subject's participation in the study will be completed. |
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| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Not Applicable | ||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Other |
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| Condition ICMJE |
|
||||||
| Intervention ICMJE | Device: Guardian Sensor (3)
Guardian Sensor (3) connected to Guardian Link (3) Transmitter and/or Guardian Connect Transmitter.
|
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| Study Arms ICMJE | Experimental: Subjects Wearing Guardian Sensor (3)s
Each subject will wear 4 Guardian Sensor (3)s connected to a Guardian Link (3) Transmitter and/or Guardian Connect Transmitter for 11 days of sensor wear.
Intervention: Device: Guardian Sensor (3)
|
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| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Completed | ||||||
| Actual Enrollment ICMJE |
19 | ||||||
| Original Estimated Enrollment ICMJE |
20 | ||||||
| Actual Study Completion Date ICMJE | August 27, 2019 | ||||||
| Actual Primary Completion Date | August 27, 2019 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT04020822 | ||||||
| Other Study ID Numbers ICMJE | CIP318 | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Medtronic Diabetes | ||||||
| Study Sponsor ICMJE | Medtronic Diabetes | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE | Not Provided | ||||||
| PRS Account | Medtronic Diabetes | ||||||
| Verification Date | August 2020 | ||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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