Mobile Insulin Titration Intervention

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.

Inclusion Criteria:

- Initiating long-acting insulin treatment or initiating the titration of long-acting
insulin treatment

- Speaks English or Spanish

- Hemoglobin A1c > or = 8%

- Able and willing to inject insulin

- Able and willing to provide informed consent

Exclusion Criteria:

- Short-acting insulin treatment

- Systemic glucocorticoids

- Sustained elevated serum creatinine > or = 1.5 mg/dL for men and > or = 1.4 mg/dL for
women

- Hypoglycemia unawareness

- Type 1 diabetes