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NCT03040414 · ClinicalTrials.gov registry record · NA
Fuzzy Logic Automated Insulin Regulation
A NA study, sponsored by HealthPartners Institute.
- Completed
- Registry status
- NA
- Development phase
- 126
- Enrollment target
NCT03040414 is a NA study that has completed, run by HealthPartners Institute. The registered enrollment target is 126 participants.
The verdict
NCT03040414, a NA study, has completed, sponsored by HealthPartners Institute.
- COMPLETED
- Registry status
- NA
- Development phase
- 126 participants
- Enrollment target
Study Summary
Adolescents and young adults with type 1 diabetes often have a difficult time achieving good glucose control, which is so important in reducing the risk for diabetes complications. Despite the use of multiple daily injections or insulin pumps and glucose sensors, there is still a need for many individuals to further improve glucose levels without causing low blood glucose levels (hypoglycemia) or adding to the daily burden of living with diabetes. Today an insulin pump can receive glucose readings from a continuous glucose monitor and adjust the insulin delivery in an attempt to keep glucose levels in a more optimal range. These systems are called hybrid closed loop (HCL). This means that much of the insulin delivery is automated, yet the patient still interacts regularly with the system, particularly to help determine the insulin dose to deliver to cover a meal. Results of early studies using HCL systems in adolescents and adults with type 1 diabetes are encouraging. The objective of this study is to compare the efficacy and safety of the automated insulin delivery (AID) system with proportional integral-derivative (PID) algorithm (Minimed 670G 3.0 HCL) to an AID system with combined PID and Fuzzy Logic Algorithm (Minimed 670G 4.0 Advanced Hybrid Closed-Loop (AHCL)). The trial will test the hypothesis that the Minimed AHCL can reduce daytime hyperglycemia, currently the biggest challenge for AID systems, without increasing hypoglycemia. Up to 124 adolescents and young adults (ages 14-\<30) will be recruited to test each system for three months in a randomized crossover trial. Investigators will compare how effective each hybrid closed loop system is at preventing high blood glucose readings during the day. The investigators will also evaluate the safety of each system and how participants adjust to the daily use of the technology.
Interventions
- DEVICE MedtronicMinimed 670G 3.0 hybrid closed loop system
- DEVICE Medtronic Minimed 670G 4.0 AHCL with Guardian Sensor (3) continuous glucose monitoring sensor.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 126 participants |
| Start Date | 2019-06-03 |
| Est. Completion | 2020-04-20 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03040414
The ClinicalTrials.gov registry entry for NCT03040414 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 126 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is HealthPartners Institute, which has 146 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which MedtronicMinimed 670G 3.0 hybrid closed loop system is the first listed.
NCT03040414 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03040414 about?
NCT03040414 is a clinical study titled "Fuzzy Logic Automated Insulin Regulation". Adolescents and young adults with type 1 diabetes often have a difficult time achieving good glucose control, which is so important in reducing the risk for diabetes complications. Despite the use of multiple daily injections or insulin pumps and glucose sensors, there is still a need for many indiv...
What is the current status of trial NCT03040414?
This trial is currently completed. It is a NA study. The enrollment target is 126 participants. The study started on 2019-06-03. Estimated completion is 2020-04-20.
What interventions are being tested in trial NCT03040414?
The interventions under investigation include: MedtronicMinimed 670G 3.0 hybrid closed loop system (DEVICE), Medtronic Minimed 670G 4.0 AHCL with Guardian Sensor (3) continuous glucose monitoring sensor. (DEVICE).
Who is sponsoring clinical trial NCT03040414?
This trial is sponsored by HealthPartners Institute, which has 146 total clinical trials registered on ClinicalTrials.gov.
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