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Managing Diabetes in Pregnancy Using Cell Phone/Internet Technology

H

Hawaii Pacific Health

Status

Completed

Conditions

Gestational Diabetes
Diabetes During Pregnancy

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT01907516
2009-118

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

100 participants in 2 patient groups, including a placebo group

Cell phone-internet first
Active Comparator group
Description:
Cell phone-internet home glucose reporting system first
Treatment:
Behavioral: Voicemail home blood glucose reporting
Device: Cell phone-internet home glucose reporting system
Voicemail first
Placebo Comparator group
Description:
Voicemail home blood glucose reporting first
Treatment:
Behavioral: Voicemail home blood glucose reporting
Device: Cell phone-internet home glucose reporting system

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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