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NCT02508779 · ClinicalTrials.gov registry record · NA
BGAT (Blood Glucose Awareness Training) for Users Who Might Become Pregnant
A NA study, sponsored by University of Virginia.
- Completed
- Registry status
- NA
- Development phase
- 54
- Enrollment target
NCT02508779 is a NA study that has completed, run by University of Virginia. The registered enrollment target is 54 participants.
The verdict
NCT02508779, a NA study, has completed, sponsored by University of Virginia.
- COMPLETED
- Registry status
- NA
- Development phase
- 54 participants
- Enrollment target
Study Summary
Ineffective management of blood glucose (BG) levels during preconception and pregnancy has been associated with severe maternal and fetal complications in women with type 1 diabetes (T1DM). Preconception care emphasizing stringent glycemic control in the preconception period and continued through early pregnancy can dramatically reduce these risks. However, the use of preconception care in the US has been disappointingly low due to a variety of organizational, provider, and patient centered factors. Furthermore, efforts to achieve tight glycemic control can increase the risk of severe hypoglycemia (SH) in T1DM women, potentially leading to serious health consequences. In this project, the investigators will test an education based Internet intervention (Bump2be or Blood glucose awareness training (BGAT) for users who might become pregnant) for use with T1DM women who are either actively trying to become pregnant (TP) or planning to become pregnant in the 12 months following their enrollment in this study (PP). The main objective is to examine Bump2be's feasibility and preliminary efficacy as an intervention for these women to better regulate their BG levels and to meet their diabetes-related clinical targets for pregnancy. More specifically, Bump2be will be tested in a randomized clinical trial in which 58 T1DM women who are either TP or PP will be recruited. As part of this pre-post study design, participants will be randomly assigned to either the Bump2be intervention (n=29) or the routine care group (n=29). Data collected will include frequency of extreme BG, consequences of extreme BG, average BG levels (HbA1c level), estimation of BG, detection of low and high BG, and psychological functioning (including fear of hypoglycemia, avoidance of hyperglycemia, well-being, and internal locus of control). Interviews with up to 10 trial participants will be conducted at the conclusion of their study participation, to enable further optimization of the intervention in pr
Interventions
- OTHER Routine Care
- BEHAVIORAL Bump2be
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2015-07 |
| Est. Completion | 2016-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02508779
The ClinicalTrials.gov registry entry for NCT02508779 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Virginia, which has 449 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Routine Care is the first listed.
NCT02508779 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02508779 about?
NCT02508779 is a clinical study titled "BGAT (Blood Glucose Awareness Training) for Users Who Might Become Pregnant". Ineffective management of blood glucose (BG) levels during preconception and pregnancy has been associated with severe maternal and fetal complications in women with type 1 diabetes (T1DM). Preconception care emphasizing stringent glycemic control in the preconception period and continued through ea...
What is the current status of trial NCT02508779?
This trial is currently completed. It is a NA study. The enrollment target is 54 participants. The study started on 2015-07. Estimated completion is 2016-10.
What interventions are being tested in trial NCT02508779?
The interventions under investigation include: Routine Care (OTHER), Bump2be (BEHAVIORAL).
Who is sponsoring clinical trial NCT02508779?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
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