Managing Diabetes in Pregnancy Using Cell Phone/Internet Technology

NCT ID: NCT01907516

Last Updated: 2015-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2011-06-30

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.

Conditions

Diabetes During Pregnancy; Gestational Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cell phone-internet first

Cell phone-internet home glucose reporting system first

Group Type: ACTIVE_COMPARATOR

Cell phone-internet home glucose reporting system

Intervention Type: DEVICE

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

Voicemail home blood glucose reporting

Intervention Type: BEHAVIORAL

Glucose monitoring via standard telephone and fax reporting.

Voicemail first

Voicemail home blood glucose reporting first

Group Type: PLACEBO_COMPARATOR

Cell phone-internet home glucose reporting system

Intervention Type: DEVICE

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

Voicemail home blood glucose reporting

Intervention Type: BEHAVIORAL

Glucose monitoring via standard telephone and fax reporting.

Interventions

Cell phone-internet home glucose reporting system

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

Intervention Type: DEVICE

Voicemail home blood glucose reporting

Glucose monitoring via standard telephone and fax reporting.

Intervention Type: BEHAVIORAL

Other Intervention Names

Confidant System

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hawaii Medical Service Association

OTHER

Sponsor Role: collaborator

Hookele Personal Health Planners

UNKNOWN

Sponsor Role: collaborator

Kapiolani Medical Center For Women & Children

OTHER

Sponsor Role: collaborator

Hawaii Pacific Health

OTHER

Sponsor Role: lead

Responsible Party

Marguerite Lisa Bartholomew, MD

Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marguerite L Bartholomew, MD

Role: PRINCIPAL_INVESTIGATOR

John A Burns University of Hawaii School of Medicine

Locations

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 16390512 (View on PubMed)

Other Identifiers

2009-118

Identifier Type: -

Identifier Source: org_study_id