NCT02508779.
Trial name or title | BGAT (Blood Glucose Awareness Training) for users who might become pregnant (Bump2Be) |
Methods | Randomised controlled trial |
Participants | Inclusion criteria: diagnosed with type 1 diabetes mellitus for ≥ 1 year; either actively trying to get pregnant or planning to become pregnant in the 12 months following enrolment in this study: own and routinely use a blood glucose memory meter; measure blood glucose > 2 times/d; able to download personal blood glucose meter onto a computer; able to read and speak English; able to provide informed consent; have regular access to a computer and the internet, be able to view the website content independently; reside in the USA Exclusion criteria: residents of another country; unable to travel for blood work |
Interventions | Intervention: Bump2Be blood glucose awareness training for pregnancy or preconception Control: routine care provided by woman's medical team |
Outcomes |
Primary outcomes: reduced frequency of extreme blood glucose (as defined by the low and high blood glucose index); reduced consequences of extreme blood glucose (e.g. diabetic ketoacidosis) Seondary outcomes: improved estimation of blood glucose; improved detection of low and high blood glucose; reduced fear of hypoglycaemia; reduced extreme avoidance of hyperglycaemia; improved well‐being; improved internal locus of control |
Starting date | Study start date: July 2015 Estimated study completion date: October 2016 |
Contact information | Lee M Ritterband, University of Virginia Behavioral Health and Technology Laboratory, USA |
Notes | Estimated enrolment: 58 |