Managing Diabetes in Pregnancy Using Cell Phone/Internet Technology

Not Applicable

Completed

Conditions: Diabetes During Pregnancy
Gestational Diabetes

Interventions: Device: Cell phone-internet home glucose reporting system
Behavioral: Voicemail home blood glucose reporting

Registration Number: NCT01907516

Lead Sponsor: Hawaii Pacific Health

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 Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 100

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

Age less than 18 year
Pregnancy >=30 weeks 1 day
Type I pregestational diabetes
Inability to speak English

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cell phone-internet first	Cell phone-internet home glucose reporting system	Cell phone-internet home glucose reporting system first
Voicemail first	Cell phone-internet home glucose reporting system	Voicemail home blood glucose reporting first
Cell phone-internet first	Voicemail home blood glucose reporting	Cell phone-internet home glucose reporting system first
Voicemail first	Voicemail home blood glucose reporting	Voicemail home blood glucose reporting first

Primary Outcome Measures

Name	Time	Method
Compliance With Home Blood Glucose Reporting	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.

Secondary Outcome Measures