BGAT (Blood Glucose Awareness Training) for Users Who Might Become Pregnant
Condition: Diabetes Mellitus, Type 1; Pregnancy
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

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 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.
    

Detailed description: 
      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.
    

Intervention name(s): Bump2be; Routine Care
Intervention type(s): Behavioral; Other
Intervention description(s): Bump2be is an internet intervention focusing on six topics (called cores) psycho-educational in nature with the goals of improving individuals' ability to: a) anticipate extreme BG levels, b) detect the presence of extreme BG levels, c) address current extreme BG levels, and d) prevent future extreme BG levels. The program includes didactic information, self-assessment tools, and active learning exercises.; Participants will continue to receive care from their clinician.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Diabetes; Blood Glucose Management; Preconception; Hypoglycemia; Women with diabetes