- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01907516
Managing Diabetes in Pregnancy Using Cell Phone/Internet Technology
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Hawaii
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Honolulu, Hawaii, United States, 96826
- Kapiolani Medical Center for Women and Children
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Cell phone-internet first
Cell phone-internet home glucose reporting system first
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Glucose monitoring via cell phone and internet using the Confidant Diabetes Management Application and the Confidant Connector.
Other Names:
Glucose monitoring via standard telephone and fax reporting.
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Placebo Comparator: Voicemail first
Voicemail home blood glucose reporting first
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Glucose monitoring via cell phone and internet using the Confidant Diabetes Management Application and the Confidant Connector.
Other Names:
Glucose monitoring via standard telephone and fax reporting.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subject Satisfaction
Time Frame: 6 weeks
|
Satisfaction was measured with a survey after completing using both reporting methods
|
6 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Marguerite L Bartholomew, MD, John A Burns University of Hawaii School of Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2009-118
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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