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

Scientific Background: The number of women with type 1 diabetes is expected to rise, particularly for those in their early reproductive years. Pre-existing diabetes in pregnancy can increase the risk of various maternal (e.g., hypoglycemia and diabetic ketoacidosis) and fetal complications. Uncontrolled BG levels immediately before and during pregnancy have been associated with miscarriage, pre-eclampsia, infant mortality and a twofold to fourfold increased risk of major congenital malformations. Maternal hyperglycemia has been shown to complicate pregnancy more than any other factor and has been associated with a higher rate of spontaneous abortions and congenital malformations. Preconception care emphasizing stringent BG control in the preconception period (at least three to six months prior to pregnancy) and continued throughout can significantly reduce these risks to levels that are similar to those reported for the non-diabetic population. These attempts to achieve tighter BG control have, however, been linked to increased incidence of SH in early pregnancy. These findings point to the critical importance of providing TIDM women with practical self-management skills that they can actively use to better manage their BG levels, and achieve their target glycemic control without undue risk of hypoglycemia in preparation for pregnancy. At present, however, there are no published behavioral interventions specifically tailored to improving detection and management of extreme BG levels in this patient population.

Rationale: The overall aim of this research is to develop (Phase 1) and test (Phase 2) the feasibility of the Bump2be Internet intervention for use with Diabetes mellitus type 1 (T1DM) women who are either TP or PP to help them effectively detect and reduce occurrences of extreme BG levels. Phase 1 of this research was submitted and approved by the Institutional Review Board (HSR# 16668) in 2013 and has been completed. The Bump2be intervention is based on BGATHome (Blood Glucose Awareness Training at Home), which is an automated, tailored, Internet delivered, psycho-educational intervention for T1DM patients. BGATHome is based on theories of self-regulation of health behavior, and the training focuses on patients' learning how to use both internal cues (e.g., physical and mood changes) and external cues (e.g., insulin and food action) to improve their BG awareness. It has proven successful in improving patients' glycemic control as well as their abilities to detect, anticipate, avoid, and treat extremes BG levels. Investigators have historically excluded T1DM women who were either pregnant or planning pregnancy from BGAT-related studies given their unique clinical needs and glycemic targets. The investigators now propose to evaluate the feasibility and effectiveness of Bump2be in women with T1DM who are either TP or PP to help them better regulate their BG levels and to meet the diabetes-related clinical targets for and during pregnancy. This protocol covers Phase 2 of this project.

Relevance: There is an urgent need to effectively support Diabetes mellitus type 1 (T1DM) women who are either TP or PP in their efforts to achieve and maintain strict glycemic control without experiencing SH. The investigators propose to test an Internet-based training program (Bump2be.org) to assist these women better anticipate, detect, manage, and prevent extreme BG occurrences to enable them to meet their glycemic goals for pregnancy. If found efficacious, Bump2be will be the first Internet-based behavioral intervention to train and assist these women achieve the recommended glycemic targets without increasing their risk of SH. The program has the potential to impact its target patients on a major public health level by supplementing their preconception care with a conveniently accessible program tailored to their specific needs. It holds promise to improve not only their BG management but also psychosocial functioning (e.g., reduced fear of hypoglycemia, improved diabetes-related quality of life and knowledge) with no additional burden on the healthcare system.