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

NCT02508779 | Completed

• 2 other identifiers: 171175R21DK095206
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus, Type 1; Pregnancy

Keywords

Diabetes; Blood Glucose Management; Preconception; Hypoglycemia; Women with diabetes

Outcome Measures

Primary Outcomes (2)

• Reduced frequency of extreme BG (as defined by the low and high BG index)

  3 months (during the intervention period)

• Reduced consequences of extreme BG (e.g., diabetic ketoacidosis, SH)

  3 months (during the intervention period)

Secondary Outcomes (6)

• Improved estimation of BG (as confirmed by BG Diary data)

  3 months (during the intervention period)

• Improved detection of low and high BG (as confirmed by BG Diary data)

  3 months (during the intervention period)

• Reduced fear of hypoglycemia (as confirmed by the Low Blood Sugar Survey)

  Assessed pre and post intervention

• Reduced extreme avoidance of hyperglycemia (as confirmed by the High Blood Sugar Survey)

  Assessed pre and post intervention

• Improved well-being (as confirmed by the Diabetes Distress Scale)

  Assessed pre and post intervention

Study Arms (2)

Bump2Be

EXPERIMENTAL

Blood Glucose Awareness Training for pregnancy or preconception

Behavioral: Bump2be

Routine Care

ACTIVE COMPARATOR

Routine care provided by subject's medical team

Other: Routine Care

Interventions

Bump2be BEHAVIORAL

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.

Bump2Be

Routine Care OTHER

Participants will continue to receive care from their clinician.

Routine Care

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• University of Virginia: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Viginia Center for Behavioral Health & Technology

Charlottesville, Virginia, 22903, United States

Location

Related Publications (3)

• Cox D, Ritterband L, Magee J, Clarke W, Gonder-Frederick L. Blood glucose awareness training delivered over the internet. Diabetes Care. 2008 Aug;31(8):1527-8. doi: 10.2337/dc07-1956. Epub 2008 May 13.

  PMID: 18477813 BACKGROUND

• Singh H, Owen S, Crook M, Gonder--Frederick L, Ingersoll & Ritterband L (2014) Women's experiences of pregnancy in type 1 diabetes: Implications for patient care. Annals of Behavioral Medicine, 47(Supplement 1): s17, A---054.

  BACKGROUND

• Singh H, Murphy HR, Hendrieckx C, Ritterband L, Speight J. The challenges and future considerations regarding pregnancy-related outcomes in women with pre-existing diabetes. Curr Diab Rep. 2013 Dec;13(6):869-76. doi: 10.1007/s11892-013-0417-5.

  PMID: 24013963 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus; Hypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Lee M Ritterband, PhD

  University of Virginia Behavioral Health & Technology Laboratory

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 21, 2015
• First Posted: July 27, 2015
• Study Start: July 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 26, 2016

Record last verified: 2016-10

Locations

US (1)