Clinical trial NCT01907516: Managing Diabetes in Pregnancy Using Cell Phone/Internet Technology
Official title: Managing Diabetes in Pregnancy Using Cell Phone/Internet Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes During Pregnancy
Gestational Diabetes
Lead sponsor: Hawaii Pacific Health
Sponsor class: OTHER
Collaborators: name: Hawaii Medical Service Association
name: Hookele Personal Health Planners
name: Kapiolani Medical Center For Women & Children
First posted: 2013-07-25
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Compliance With Home Blood Glucose Reporting
timeFrame: 6 weeks
Secondary outcomes:
measure: Subject Satisfaction
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: Kapiolani Medical Center for Women and Children
state: Hawaii
Study officials:
affiliation: John A Burns University of Hawaii School of Medicine
name: Marguerite L Bartholomew, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jackson CL, Bolen S, Brancati FL, Batts-Turner ML, Gary TL. A systematic review of interactive computer-assisted technology in diabetes care. Interactive information technology in diabetes care. J Gen Intern Med. 2006 Feb;21(2):105-10. doi: 10.1111/j.1525-1497.2005.00310.x. Epub 2005 Dec 22.