Managing Diabetes in Pregnancy Using Cell Phone/Internet Technology

Gestational Diabetes Clinical Trial

Official title:

Managing Diabetes in Pregnancy Using Cell Phone/Internet Technology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01907516
• Other study ID #: 2009-118
• Status: Completed
• Phase: N/A
• First received: July 22, 2013
• Last updated: May 29, 2015
• Start date: February 2009
• Est. completion date: June 2011

Study information

• Verified date: May 2015
• Source: Hawaii Pacific Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2011
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes During Pregnancy
• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes
• Pregnancy in Diabetics

Intervention

Device:
• Cell phone-internet home glucose reporting system
Glucose monitoring via cell phone and internet using the Confidant Diabetes Management Application and the Confidant Connector.

Behavioral:
• Voicemail home blood glucose reporting
Glucose monitoring via standard telephone and fax reporting.

Locations

Country	Name	City	State
United States	Kapiolani Medical Center for Women and Children	Honolulu	Hawaii

Sponsors (4)

Lead Sponsor	Collaborator
Hawaii Pacific Health	Hawaii Medical Service Association, Hookele Personal Health Planners, Kapiolani Medical Center For Women & Children

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Epub 2005 Dec 22. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compliance With Home Blood Glucose Reporting	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.	6 weeks	No
Secondary	Subject Satisfaction	Satisfaction was measured with a survey after completing using both reporting methods	6 weeks	No