BGAT (Blood Glucose Awareness Training) for Users Who Might Become Pregnant
| Status: | Recruiting |
|---|---|
| Conditions: | Women's Studies, Diabetes |
| Therapuetic Areas: | Endocrinology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 64 |
| Updated: | 5/12/2016 |
| Start Date: | July 2015 |
| End Date: | October 2016 |
| Contact: | Harsimran Singh, PhD |
| Email: | HS9DC@hscmail.mcc.virginia.edu |
| Phone: | (434) 982-1022 |
Blood Glucose Training for Women With Type 1 Diabetes Contemplating Pregnancy
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.
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.
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- Residents of another country
- Unable to travel to Lab Corp for blood work
We found this trial at
1
site
Charlottesville, Virginia 22903
Principal Investigator: Lee M Ritterband, PhD
Phone: 434-924-5988
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