BGAT (Blood Glucose Awareness Training) for Users Who Might Become Pregnant

Completed · Not applicable

Conditions studied: Diabetes Mellitus, Type 1, Pregnancy

In brief

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 preparation for a subsequent R01 submission. This will be the first study investigating the use of the Internet to improve detection and management of extreme BG levels in Diabetes mellitus type 1 (T1DM) women who are either TP or PP.

Key facts

Study ID

NCT02508779

Run by

University of Virginia

People needed

54

Starts

2015-07-01

Expected to finish

2016-10-01

Last updated by the study team

2016-10-26

Who can join

Age: 18 and older, up to 64. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Must be diagnosed with T1DM for at least a year
• Either actively trying to get pregnant or planning to become pregnant in the 12 months following enrollment in this study
• Own and routinely use a BG memory meter
• Measure BG more than twice per day
• Should be able to download personal BG meter onto a computer
• Be able to read and speak English
• Be able to provide informed consent
• Have regular access to a computer and the Internet, and be able to view the website content independently
• Reside in the United States

You may not qualify if…

• Residents of another country
• Unable to travel to Lab Corp for blood work

Where it is running

• University of Viginia Center for Behavioral Health & Technology — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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