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| Name | Class |
|---|---|
| Hawaii Medical Service Association | OTHER |
| Hookele Personal Health Planners | UNKNOWN |
| Kapiolani Medical Center For Women & Children | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cell phone-internet first | Active Comparator | Cell phone-internet home glucose reporting system first |
|
| Voicemail first | Placebo Comparator | Voicemail home blood glucose reporting first |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cell phone-internet home glucose reporting system | Device | Glucose monitoring via cell phone and internet using the Confidant Diabetes Management Application and the Confidant Connector. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Subject Satisfaction | Satisfaction was measured with a survey after completing using both reporting methods | 6 weeks |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Marguerite L Bartholomew, MD | John A Burns University of Hawaii School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kapiolani Medical Center for Women and Children | Honolulu | Hawaii | 96826 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16390512 | Background | 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. |
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Subjects were participants in the Kapiolani Medical Center for Women and Children's (KMCWC) diabetes in pregnancy program known as "A Sweeter Choice". Subjects were enrolled between February 4, 2009 and 3/11/2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cell Phone-internet First, Then Voicemail | Cell phone-internet home glucose reporting system first, then voicemail |
| FG001 | Voicemail First, Then Cell Phone-internet | Voicemail home blood glucose reporting first, then cell phone-internet |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (3 Weeks) |
|
| |||||||||||||||||||||
| Second Intervention (3 Weeks) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cell Phone-internet First, the Voicemail | Cell phone-internet home glucose reporting system first |
| BG001 | Voicemail First, Then Cell Phone-internet | Voicemail home blood glucose reporting first |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | percentage of expected glucose tests | 6 weeks |
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cell Phone-internet First, Then Voicemail | Cell phone-internet home glucose reporting system first |
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Selection bias towards English speaking, educated, and technology savvy women, a 25% drop out rate, a high rate of glucose reporting compliance in the control system, and technical problems when Confidant first started which were quickly resolved.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marguerite Lisa Bartholomew MD | John A Burns School of Medicine / University of Hawaii Dept of Obstetrics and Gynecology | 808-983-6761 | mbarthol@hawaii.edu |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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|
| Voicemail home blood glucose reporting | Behavioral | Glucose monitoring via standard telephone and fax reporting. |
|
| Delivered before second arm |
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| Developed DKA during study |
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| NOT COMPLETED |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Subject Satisfaction | Satisfaction was measured with a survey after completing using both reporting methods | Posted | Number | percentage of participants | 6 weeks |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Voicemail First, Then Cell Phone-internet | Voicemail home blood glucose reporting first | 0 | 50 | 0 | 50 |
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| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |