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NCT01653210 · ClinicalTrials.gov registry record
Development of an Advisory System for Glycemic Control During the Menstrual Cycle in Patient With Type 1 Diabetes
A clinical trial of Type 1 Diabetes Mellitus, sponsored by University of Virginia.
- Completed
- Registry status
- 15
- Enrollment target
- 1
- Study location
NCT01653210: Completed study of Type 1 Diabetes Mellitus, sponsored by University of Virginia.
NCT01653210 is a study of Type 1 Diabetes Mellitus that has completed, run by University of Virginia. The registered enrollment target is 15 participants, below the 172-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01653210, a study of Type 1 Diabetes Mellitus, has completed, sponsored by University of Virginia.
- COMPLETED
- Registry status
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
This overall research goal will be to develop a mobile-based module to improve glycemic control during the menstrual cycle in women with Type 1 diabetes mellitus (T1DM). This module will run on an Android Operating System (OS) and will be available as: (i) a stand-alone application and (ii) an important additional component to a larger system, the Diabetes Assistant (DiAs) - a mobile-based medical platform for diabetes applications. This proposal aims to build one such application or module targeting the improvement of diabetes control in younger women who experience glucose variation related to their menstrual cycle.
Primary Outcome
Measure of Hyperglycemic Risk based on frequency and severity of hyperglycemic events. HBGI \< 4.5 is associated with lower risk of hyperglycemia, 4.5 \< HBGI \< 9 is associated with a moderate risk of hyperglycemia and HBGI \> 9 is associated with high risk of hyperglycemia. Our primary outcome measure is hyperglycemia risk during the luteal phase of the menstrual cycle. The primary hypothesis is there is an increased hyperglycemia risk during the luteal phase when compared to the follicular
Conditions Studied
Study Locations (1)
Virginia
- University of Virginia Center for Diabetes Technology - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2012-08 |
| Est. Completion | 2013-09 |
What the finished NCT01653210 record still lists
NCT01653210 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 172-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Type 1 Diabetes Mellitus appearing as the primary indexed condition, and to 0 interventions.
NCT01653210 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT01653210 about?
NCT01653210 is a clinical study titled "Development of an Advisory System for Glycemic Control During the Menstrual Cycle in Patient With Type 1 Diabetes". This overall research goal will be to develop a mobile-based module to improve glycemic control during the menstrual cycle in women with Type 1 diabetes mellitus (T1DM). This module will run on an Android Operating System (OS) and will be available as: (i) a stand-alone application and (ii) an impor...
What is the current status of trial NCT01653210?
This trial is currently completed. The enrollment target is 15 participants. The study started on 2012-08. Estimated completion is 2013-09.
What conditions does trial NCT01653210 study?
This clinical trial studies the following conditions: Type 1 Diabetes Mellitus.
Who is sponsoring clinical trial NCT01653210?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01653210 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Type 1 Diabetes Mellitus
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 NCT01653210's enrollment target sits among peer trials
15 102nd of 112 higher than 10 of 112 other Type 1 Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes Mellitus 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
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