Clinical Trial: Managing Diabetes in Pregnancy Using Cell Phone/Internet Technology

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Managing Diabetes in Pregnancy Using Cell Phone/Internet Technology

Brief Summary: To compare compliance and satisfaction between a traditional method of blood glucose reporting using voicemail (control) and a novel method using cell phone /internet (Confidant) technology in the management of diabetic pregnant women.

Detailed Summary:

Control of blood glucose levels is beneficial during pregnancy, however, the ability to effectively monitor patient's blood glucose levels is challenging and time consuming for patients and care providers. Patients must keep track of their own glucose levels and take the initiative to check blood glucose multiple times per day. Traditionally, patients record their glucose levels in a logbook, which they bring with them during an office visit or use to report their glucose levels over the phone. Non compliance and factitious reporting are not uncommon. Obstetricians and or diabetes program staff spend hours communicating with patients to obtain and record glucose values therefore alternatives to phone calls are needed.

Investigators performed a prospective randomized cross over study comparing a conventional voicemail (control) system for home glucose reporting with a cell phone/internet reporting system (Confidant). The primary outcome measure was compliance with home blood glucose fingerstick reporting. Compliance was determined by the number of home glucose fingersticks reported / expected (%). The secondary outcome was patient satisfaction. Subjects were participants in the Kapiolani Medical Center for Women and Children's diabetes in pregnancy program known as "A Sweeter Choice". IRB approval was obtained before starting the study and all subjects received informed consent. The study was funded by Hawai'i Medical Service Association, a medical insurance company in Hawaii. The Confidant equipment was supplied by Hookele Personal Health Planners, LLC. None of the Ho'okele or Hawaii Medical Service Association staff were involved in data collection or analysis. Study subjects were randomized to Confidant or the control system at the entry into the diabetes program during consultation with the Maternal Fetal Medicine physician. After randomization, subjects perf
Sponsor: Hawaii Pacific Health

Current Primary Outcome: Compliance With Home Blood Glucose Reporting [ Time Frame: 6 weeks ]

Compliance was calculated as a percentage for each method (Confidant or Voicemail) by dividing the total number of reported glucose readings among all participants by the total number of expected readings (4 daily) over the 6 week study time period. Women with gestational diabetes are instructed to monitor their glucose 4 times per day.


Original Primary Outcome: Compliance With Home Blood Glucose Reporting [ Time Frame: 6 weeks ]

Compliance was determined by the number of home blood glucose determinations reported / expected (%).


Current Secondary Outcome: Subject Satisfaction [ Time Frame: 6 weeks ]

Satisfaction was measured with a survey after completing using both reporting methods


Original Secondary Outcome: Same as current

Information By: Hawaii Pacific Health

Dates:
Date Received: July 22, 2013
Date Started: February 2009
Date Completion:
Last Updated: May 29, 2015
Last Verified: May 2015