Managing Diabetes in Pregnancy Using Cell Phone/Internet Technology
Primary Purpose
Diabetes During Pregnancy, Gestational Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cell phone-internet home glucose reporting system
Voicemail home blood glucose reporting
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes During Pregnancy
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
Sites / Locations
- Kapiolani Medical Center for Women and Children
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Cell phone-internet first
Voicemail first
Arm Description
Cell phone-internet home glucose reporting system first
Voicemail home blood glucose reporting first
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Subject Satisfaction
Satisfaction was measured with a survey after completing using both reporting methods
Full Information
NCT ID
NCT01907516
First Posted
July 22, 2013
Last Updated
May 29, 2015
Sponsor
Hawaii Pacific Health
Collaborators
Hawaii Medical Service Association, Hookele Personal Health Planners, Kapiolani Medical Center For Women & Children
1. Study Identification
Unique Protocol Identification Number
NCT01907516
Brief Title
Managing Diabetes in Pregnancy Using Cell Phone/Internet Technology
Official Title
Managing Diabetes in Pregnancy Using Cell Phone/Internet Technology
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hawaii Pacific Health
Collaborators
Hawaii Medical Service Association, Hookele Personal Health Planners, Kapiolani Medical Center For Women & Children
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes During Pregnancy, Gestational Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cell phone-internet first
Arm Type
Active Comparator
Arm Description
Cell phone-internet home glucose reporting system first
Arm Title
Voicemail first
Arm Type
Placebo Comparator
Arm Description
Voicemail home blood glucose reporting first
Intervention Type
Device
Intervention Name(s)
Cell phone-internet home glucose reporting system
Other Intervention Name(s)
Confidant System
Intervention Description
Glucose monitoring via cell phone and internet using the Confidant Diabetes Management Application and the Confidant Connector.
Intervention Type
Behavioral
Intervention Name(s)
Voicemail home blood glucose reporting
Intervention Description
Glucose monitoring via standard telephone and fax reporting.
Primary Outcome Measure Information:
Title
Compliance With Home Blood Glucose Reporting
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Subject Satisfaction
Description
Satisfaction was measured with a survey after completing using both reporting methods
Time Frame
6 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marguerite L Bartholomew, MD
Organizational Affiliation
John A Burns University of Hawaii School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kapiolani Medical Center for Women and Children
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96826
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16390512
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.
Results Reference
background
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