Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826, United States
NCT Number: NCT01907516
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.
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Notify Me18 year and older
Female
Interventional
Not applicable
Honolulu, Hawaii, 96826, United States
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 performed the assigned monitoring system for 3 weeks. After three weeks, they switched to the other monitoring system. A satisfaction survey was completed after three weeks on the second system was completed.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
-Pregnant women >=18 years with gestational diabetes or pregestational Type 2 diabetes referred to the diabetes in pregnancy management program before 30 weeks 1 day gestation.
Exclusion criteria
Glucose monitoring via cell phone and internet using the Confidant Diabetes Management Application and the Confidant Connector.
Other names: Confidant System
Glucose monitoring via standard telephone and fax 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.
Time frame: 6 weeks
Satisfaction was measured with a survey after completing using both reporting methods
Hawaii Pacific Health
Other
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