Diabetes During Pregnancy, Gestational Diabetes
Conditions
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.
Interventions
DEVICECell phone-internet home glucose reporting system
Glucose monitoring via cell phone and internet using the Confidant Diabetes Management Application and the Confidant Connector.
BEHAVIORALVoicemail home blood glucose reporting
Glucose monitoring via standard telephone and fax reporting.
Sponsors
Hawaii Medical Service Association
Hookele Personal Health Planners
Kapiolani Medical Center For Women & Children
Hawaii Pacific Health
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compliance With Home Blood Glucose Reporting | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject Satisfaction | 6 weeks | Satisfaction was measured with a survey after completing using both reporting methods |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Cell Phone-internet First, the Voicemail Cell phone-internet home glucose reporting system first | 50 |
| Voicemail First, Then Cell Phone-internet Voicemail home blood glucose reporting first | 50 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention (3 Weeks) | Delivered before second arm | 3 | 4 |
| First Intervention (3 Weeks) | Developed DKA during study | 1 | 0 |
| First Intervention (3 Weeks) | Lost to Follow-up | 1 | 3 |
| First Intervention (3 Weeks) | Withdrawal by Subject | 5 | 9 |
Baseline characteristics
| Characteristic | Voicemail First, Then Cell Phone-internet | Cell Phone-internet First, the Voicemail | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 50 Participants | 50 Participants | 100 Participants |
| Age, Continuous | 32.5 years STANDARD_DEVIATION 5.76 | 33.79 years STANDARD_DEVIATION 4.94 | 33.12 years STANDARD_DEVIATION 5.37 |
| Region of Enrollment United States | 50 participants | 50 participants | 100 participants |
| Sex: Female, Male Female | 50 Participants | 50 Participants | 100 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
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.
Time frame: 6 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Used Confidant Method | Compliance With Home Blood Glucose Reporting | 89.3 percentage of expected glucose tests |
| Used Voicemail Method | Compliance With Home Blood Glucose Reporting | 87.6 percentage of expected glucose tests |
Secondary
Subject Satisfaction
Satisfaction was measured with a survey after completing using both reporting methods
Time frame: 6 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Used Confidant Method | Subject Satisfaction | 67 percentage of participants |