Managing Diabetes in Pregnancy Using Cell Phone/Internet Technology

Study Overview
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Brief Summary
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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
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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.

Official Title
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Managing Diabetes in Pregnancy Using Cell Phone/Internet Technology

Conditions
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Diabetes During Pregnancy, Gestational Diabetes

Intervention / Treatment
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* Device: Cell phone-internet home glucose reporting system
* Behavioral: Voicemail home blood glucose reporting


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cell phone-internet first<br>Cell phone-internet home glucose reporting system first | Device: Cell phone-internet home glucose reporting system<br>* Glucose monitoring via cell phone and internet using the Confidant Diabetes Management Application and the Confidant Connector.<br>* Other names: Confidant System;Behavioral: Voicemail home blood glucose reporting<br>* Glucose monitoring via standard telephone and fax reporting.<br>|
| Placebo Comparator: Voicemail first<br>Voicemail home blood glucose reporting first | Device: Cell phone-internet home glucose reporting system<br>* Glucose monitoring via cell phone and internet using the Confidant Diabetes Management Application and the Confidant Connector.<br>* Other names: Confidant System;Behavioral: Voicemail home blood glucose reporting<br>* Glucose monitoring via standard telephone and fax reporting.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject Satisfaction | Satisfaction was measured with a survey after completing using both reporting methods | 6 weeks |