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OpenTrials
Completed

NCT Number: NCT01907516

Managing Diabetes in Pregnancy Using Cell Phone/Internet Technology

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.

Completed

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826, United States

About this study

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.

Who can participate

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

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

Treatment and study plan

Cell phone-internet home glucose reporting system

Device

Glucose monitoring via cell phone and internet using the Confidant Diabetes Management Application and the Confidant Connector.

Other names: Confidant System

Voicemail home blood glucose reporting

Behavioral

Glucose monitoring via standard telephone and fax reporting.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Subject Satisfaction

    Time frame: 6 weeks

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

Sponsors and collaborators

Lead sponsor

Hawaii Pacific Health

Other

Collaborators

  • Hawaii Medical Service Association
  • Hookele Personal Health Planners
  • Kapiolani Medical Center For Women & Children

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Jul 25, 2013
Registry last updated
Jun 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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