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NCT04428645 · ClinicalTrials.gov registry record · NA
Assessment of a Decision Support Tool in Participants With Type 1 Diabetes
A NA study of Type 1 Diabetes, sponsored by Oregon Health and Science University.
- Completed
- Registry status
- NA
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT04428645 is a NA study of Type 1 Diabetes that has completed, run by Oregon Health and Science University. The registered enrollment target is 25 participants, below the 824-participant average among 178 other Type 1 Diabetes trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04428645, a NA study of Type 1 Diabetes, has completed, sponsored by Oregon Health and Science University.
- COMPLETED
- Registry status
- NA
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
Type 1 diabetes (T1D) is a complex disease with a high risk of both hyper- and hypoglycemia which can lead to severe acute and chronic complications. The burden and complexity of managing T1D results in the majority of people not reaching adequate glycemic control. Our team has developed a smartphone based application, DailyDose, that combines continuous glucose monitoring data and insulin data to provide decision support for subjects with type 1 diabetes taking multiple daily injections (MDI). DailyDose provides on-demand, real-time dosing recommendations for insulin doses prior to meals and to correct hyperglycemia. DailyDose analyzes glucose patterns and provides weekly recommendations to the patient on insulin settings including carbohydrate ratios and correction factors. As needed, DailyDose will make weekly recommendations to change basal insulin. For subject safety, study investigators will set constraints on settings for short and long acting insulin during the onboarding process. DailyDose will not be able to recommend insulin dose changes above or below the set safety thresholds. DailyDose also provides recommendations on carbohydrate intake for exercise and includes hypoglycemia and hyperglycemia alarms.
Conditions Studied
Interventions
- DEVICE DailyDose Decision Support
Study Locations (1)
Oregon
- Oregon Health and Science University - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2020-07-21 |
| Est. Completion | 2021-11-15 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04428645
The ClinicalTrials.gov registry entry for NCT04428645 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 824-participant average among 178 other Type 1 Diabetes trials with a reported enrollment target (97% lower). The listed sponsor is Oregon Health and Science University, which has 546 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Type 1 Diabetes appearing as the primary indexed condition, and to 1 intervention - of which DailyDose Decision Support is the first listed.
NCT04428645 reports 1 study location spanning 1 distinct geographic area - top geographies include Oregon.
Frequently Asked Questions
What is clinical trial NCT04428645 about?
NCT04428645 is a clinical study titled "Assessment of a Decision Support Tool in Participants With Type 1 Diabetes". Type 1 diabetes (T1D) is a complex disease with a high risk of both hyper- and hypoglycemia which can lead to severe acute and chronic complications. The burden and complexity of managing T1D results in the majority of people not reaching adequate glycemic control. Our team has developed a smartphon...
What is the current status of trial NCT04428645?
This trial is currently completed. It is a NA study. The enrollment target is 25 participants. The study started on 2020-07-21. Estimated completion is 2021-11-15.
What conditions does trial NCT04428645 study?
This clinical trial studies the following conditions: Type 1 Diabetes.
What interventions are being tested in trial NCT04428645?
The interventions under investigation include: DailyDose Decision Support (DEVICE).
Who is sponsoring clinical trial NCT04428645?
This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04428645 being conducted?
This trial has 1 study location across Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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