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NCT03674281 · ClinicalTrials.gov registry record · NA

The VRIF Trial: Hypoglycemia Reduction With Automated-Insulin Delivery System

A NA study of Type 1 Diabetes Mellitus and Cognitive Change, sponsored by University of Virginia.

Completed
Registry status
NA
Development phase
50
Enrollment target
1
Study location

NCT03674281 is a NA study of Type 1 Diabetes Mellitus and Cognitive Change that has completed, run by University of Virginia. The registered enrollment target is 50 participants, below the 140-participant average among 105 other Type 1 Diabetes Mellitus trials with a reported enrollment target (64% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03674281, a NA study of Type 1 Diabetes Mellitus and Cognitive Change, has completed, sponsored by University of Virginia.

COMPLETED
Registry status
NA
Development phase
50 participants
Enrollment target
1
Study location

Study Summary

The objective of this pilot study is (i) to test the use of an Artificial Pancreas (AP) System as a viable therapy treatment for two vulnerable populations: 6 to 10 year-old and adults older ≥65 years old with T1D; (ii) to assess cognitive function in children and older adult patients with T1D and examine whether improved glycemic control defined by stable (more than 70% of the day in glycemic range 70-180 mg/dL) control positively influences cognitive function; and (iii) obtain preliminary data to apply to funds to continue with larger and longer clinical trials.

Interventions

  • DEVICE SAP
  • DEVICE CLC

Study Locations (1)

Virginia

  • University of Virginia - Charlottesville

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2018-09-24
Est. Completion 2019-11-21
Phase NA

Sponsor

University of Virginia

449 total trials

What the Registry Record Tells You About NCT03674281

The ClinicalTrials.gov registry entry for NCT03674281 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 140-participant average among 105 other Type 1 Diabetes Mellitus trials with a reported enrollment target (64% lower). The listed sponsor is University of Virginia, which has 449 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Type 1 Diabetes Mellitus appearing as the primary indexed condition, and to 2 interventions - of which SAP is the first listed.

NCT03674281 reports 1 study location spanning 1 distinct geographic area - top geographies include Virginia.

Frequently Asked Questions

What is clinical trial NCT03674281 about?

NCT03674281 is a clinical study titled "The VRIF Trial: Hypoglycemia Reduction With Automated-Insulin Delivery System". The objective of this pilot study is (i) to test the use of an Artificial Pancreas (AP) System as a viable therapy treatment for two vulnerable populations: 6 to 10 year-old and adults older ≥65 years old with T1D; (ii) to assess cognitive function in children and older adult patients with T1D and e...

What is the current status of trial NCT03674281?

This trial is currently completed. It is a NA study. The enrollment target is 50 participants. The study started on 2018-09-24. Estimated completion is 2019-11-21.

What conditions does trial NCT03674281 study?

This clinical trial studies the following conditions: Type 1 Diabetes Mellitus, Cognitive Change.

What interventions are being tested in trial NCT03674281?

The interventions under investigation include: SAP (DEVICE), CLC (DEVICE).

Who is sponsoring clinical trial NCT03674281?

This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03674281 being conducted?

This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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