Texting for Diabetes
Texting for Diabetes
Diabetes is a common complication of pregnancy that increases risks for both the mother and
 baby. Poorly controlled diabetes has been associated with very large babies, congenital heart
 defects, stillbirth, birth trauma, and maternal infections among other complications.
 Patients with diabetes in pregnancy require more frequent prenatal visits and fetal
 evaluation, and must shoulder the burden of mastering management of a complicated care
 regimen. With the ever-expanding world of technology, more healthcare practices are using
 cell phones, texting, and social media to interact with patients. Use of this technology has
 been successful in management of chronic diseases and as reminder systems. The investigators
 propose a randomized clinical trial to investigate patient adherence to recommended care
 regimen after intervention of a text message reminder and education system.
As a part of routine care, pregnant women without known diabetes undergo screening and
 testing for gestational diabetes either with a two-hour glucose tolerance testing or a
 one-hour glucose challenge test followed by a three-hour glucose tolerance test in the event
 of failure of the one-hour test.

 Women who have been given the diagnosis of gestational diabetes mellitus (GDM) by failing
 this diabetes testing and who meet the inclusion and exclusion criteria shall be approached
 and offered enrollment in the study. Women with known type 2 diabetes mellitus (T2DM)
 (pre-gestational diabetes) and women diagnosed elsewhere with GDM who meet the inclusion and
 exclusion criteria will be offered enrollment when they establish prenatal care. Patients who
 consent to participate in the study shall be randomized to either the intervention or the
 contact control group. For randomization purposes, an equal number of notecards will be made
 for the two groups. These will all be placed in sealed envelopes and shuffled. At the time of
 patient inclusion, an envelope will be selected by the consenting practitioner. If a patient
 declines receiving text messages but consents to have her medical record reviewed for
 adherence to her diabetes care regimen and glycemic control, she will be enrolled in the
 standard of care control group. A baseline hemoglobin A1c (HbA1c) is obtained.

 Patients in all groups shall receive initial diabetes education and started on an
 individualized diabetic diet regimen. Patients with GDM who develop a requirement for either
 oral medication or insulin will remain in the same group to which they were initially
 randomized. An HbA1c level is obtained every one to three months during pregnancy as well as
 near the time of delivery.

 Patients in the intervention group will receive reminders based on their individual disease
 treatment. A text message shall be sent one day (12 to 36 hours) before appointments to
 remind about the appointment and with instructions to bring glucose and food records to the
 appointment. If medication changes are made at the appointment, the patient will receive a
 text message reminder the day after her appointment to reinforce the regimen. Postpartum
 patients who had GDM will receive a text message reminder to complete their glucose tolerance
 test. A reminder will be sent at 2 weeks postpartum followed by a reminder at 6 weeks and 10
 weeks postpartum if the testing is not completed. Women with T2DM will be reminded to bring
 glucose and food records to their postpartum visits. Participants will be contacted through
 Google Voice which is a Google system requiring a secure login and password.

 Patients in the contact control group will be enrolled in the text4baby program with
 assistance from a healthcare provider. As the study will conclude upon the patient's
 postpartum visit, she will be offered the option of discontinuing messages, which otherwise
 would continue through the infant's first year of life.

 Hospitalizations Patient hospitalization for diabetic control shall be recorded for data
 collection. Patients in the intervention group will not be contacted during their
 hospitalization. If medicine adjustments are made during their hospitalization, a reminder
 text message with the new regimen shall be sent the day after discharge. Contact will then
 resume by the above stated schedule. If a patient is hospitalized temporarily for a reason
 other than diabetes, contact will resume upon discharge. If the patient is hospitalized for
 the remainder of the pregnancy, the patient will be removed from the study. Triage visits
 will not be followed.

 Delivery Delivery details will be abstracted from patient charts and shall include
 gestational age at delivery, fetal weight, vaginal versus cesarean delivery, incidence of
 shoulder dystocia, APGAR scores, and umbilical cord blood gases. The newborn chart shall be
 reviewed for the number of days spent in the neonatal intensive care unit, incidence of
 hypoglycemia and whether IV dextrose was required, and need for ventilator support or
 surfactant administration.

 Maternal Complications Incidence of postpartum wound infections or dehiscence shall be
 collected.

 Postpartum The postpartum glucose tolerance tests of women who had GDM will be reviewed to
 determine her glucose tolerance status.

 Questionnaires/Surveys The participating patients will be asked to complete a survey upon
 entry into the study to identify barriers to their healthcare and their baseline knowledge of
 diabetes. A survey at the completion of their study (the postpartum visit or later) will be
 requested to evaluate patient perspectives on the study, their pregnancy and any perceived
 benefit from participation. The postpartum survey will be either completed at a postpartum
 visit, mailed to subjects, completed on line or subjects will be contacted by phone to
 complete the survey. If subjects do not return for a postpartum visit or do not complete the
 survey at that visit, three attempts will be made to contact subject for completion of the
 departure survey.

 For participants who did not sign a version of the consent form that allowed for completion
 of the departure survey over the phone or online:

 If their participation is ongoing, they will be approached at one of their visits and asked
 to review and sign an updated version of the consent form.

 For subjects who have completed the pregnancy portion of their participation in the study but
 who did not complete a departure survey:

 Subjects will be contacted over the phone to obtain permission to allow completion of this
 survey over the phone, by mail or online. A phone script will be used to contact patients. If
 subjects cannot be reached by phone, a letter will be sent to their home address. A maximum
 of three phone attempts will be made to contact subject.
Inclusion Criteria:

 1. The patient is a pregnant female 18 years of age or older

 2. The patient has been diagnosed with gestational diabetes or is a patient with known
 diabetes and a confirmed viable pregnancy

 3. The pregnancy has a singleton pregnancy

 4. The patient has access to a cellular phone with a text messaging plan

 Exclusion Criteria:

 1. The patient does not have a cellular phone

 2. The patient becomes hospitalized for a pregnancy complication for the remainder of
 pregnancy

 3. The fetus has a chromosomal or non-chromosomal malformation