Mobile Insulin Titration Intervention
Condition: Diabetes Mellitus
Study type: Interventional

Summary: 
      The purpose of this pilot study is to determine whether text message (and phone)
      communication can be effectively utilized to adjust long-acting insulin, compared to standard
      practice.
    

Detailed description: 
      The current practice of insulin titration for diabetics requires multiple in-person clinic
      visits, during which a patient's long-acting insulin dose is adjusted until the optimal dose
      to control glycemia is reached. Finding this optimal dose can take weeks in an ideal setting,
      but often takes much longer in a busy urban clinic such as Bellevue Hospital Center. Relaying
      titration instructions to patients via phone and text message has the potential to decrease
      the titration timeline, thus reducing the number of clinic visits and the time it takes
      patients to reach their target blood glucose levels.

      For this pilot project, study staff will recruit patients who are initiating long-acting
      insulin treatment or initiating the titration of their existing long acting insulin treatment
      at Bellevue Hospital Center's Adult Primary Care Center. Patients who volunteer to enroll and
      provide informed consent will be randomized to one of two arms (MITI or current best practice
      arm) at the time of enrollment and stratified by whether the patient is initiating insulin
      treatment or initiating the titration of his/her existing insulin dose. The study staff will
      provide a cell phone (for temporary use) to any patients who are randomized to the MITI arm
      and don't own a personal cell phone (or whose personal cell phone is not able to receive the
      Sense Health text messages). Patients will use the cell phone free of cost to participate in
      the intervention (receive Sense Health text messages, send their fasting blood glucose
      levels, and speak with the diabetes nurse and study staff.)

      Patients in the MITI arm will receive automated text messages 5 weekdays per week, for up to
      12 weeks, from Sense Health. These text messages will request the patient's fasting blood
      glucose level. The patient will reply with his/her fasting blood glucose value, which will be
      logged in password-protected accounts on www.sensehealth.com. The clinic's diabetes nurses
      will check each patient's fasting blood glucose level on www.sensehealth.com each weekday and
      call any patient with fasting blood glucose values < 80 mg/dL and > 400 mg/dL. Each Thursday,
      patients will receive a phone call from a nurse, who will adjust the patient's insulin dose
      according to the study titration protocol. Each patient will continue to receive daily text
      messages and weekly phone calls until the first of three events occur: the patient reaches
      his/her optimal insulin dose for achieving glycemic control, 12 weeks elapse, or the patient
      withdraws from the study.

      Patients in the current best practice arm (CBP) will attend scheduled clinic appointments
      during which a provider will review the patient's fasting blood glucose log and titrate the
      insulin dose according to current best practice.

      Patients in both arms will continue receiving routine care, including HbA1c values every 3
      months and other routine labs and measures as per standard of care.
    

Intervention name(s): Mobile Insulin Titration Intervention
Intervention type(s): Other
Intervention description(s): Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration.
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Insulin; Telemedicine