Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed NA study of Type 1 Diabetes, sponsored by Oregon Health and Science University.
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 767-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Mean change in the percent of time with sensed glucose between 70 - 180 mg/dl based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.
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 |
What the finished NCT04428645 record still lists
NCT04428645 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 767-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (97% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Type 1 Diabetes
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04428645's enrollment target sits among peer trials
25 136th of 198 higher than 59 of 198 other Type 1 Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
REAL-Fam Feasibility Study for Youth Diabetes Management
RECRUITING · NA
-
AIDANET Pediatrics
RECRUITING · NA
-
A Study Comparing Dexcom Continuous Glucose Monitoring to Point of Care Glucose Testing for the Management of Hospital and Post-Discharge Subjects With Type 1 Diabetes
RECRUITING · NA
-
Safety and Feasibility of a Self-Learning Bolus Calculator With Simplified Meal Announcement in Adolescents With Type 1 Diabetes Using Automated Insulin Delivery
RECRUITING · NA
-
EMPoWER Study - Strengths-based Behavioral Intervention for Youth With Type 1 Diabetes
RECRUITING · NA
-
Safety and Feasibility of a Machine-Learning Bolus Priming Added to Existing Control Algorithm
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01166854 · 25 participants
Characterization of Familial Myopathy and Paget Disease of Bone
- NCT01913106 · 25 participants · Phase 1
HSV-tk + Valacyclovir Therapy in Combination With Brachytherapy for Recurrent Prostate Cancer
- NCT02138669 · 25 participants · NA
Intacs Prescription Inserts for Keratoconus Patients
- NCT02174549 · 25 participants · Phase 1
Dose-defining Study of Tirapazamine Combined With Embolization in Liver Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI