Levy 2015.

Study characteristics
Methods	The Mobile Insulin Titration Intervention (MITI) for insulin adjustment in an urban, low‐income population: randomized controlled trial RCT (NA clusters and NA providers), conducted in 1) We recruited patients for this study from Bellevue’s Adult Primary Care Center (APCC) in New York city. Most clinic visits are for patients who are uninsured (31%) or have Medicaid (45%). The majority of patients are non‐white: Hispanic (41%), Black (24%) and Asian (6%). 2) The intervention was provided by clinic’s diabetes nurse educator helped by a physician if not available. In United States of America. 2 arms: 1. Control (standard care) (control arm) and 2. Intervention (Mobile Insulin Titration Intervention‐MITI) (intervention arm)
Participants	Control arm N: 28 Intervention arm N: 33, NA, NA Diabetes type: 2 Mean age: 46.7 ± NR % Male: 49 Longest follow‐up: 2.77 months
Interventions	Control arm: (standard care) 1) Promotion of self‐management Intervention arm: (Mobile Insulin Titration Intervention‐MITI) 1) Case management 2) Team change 3) Electronic patient registry 4) Facilitated relay of clinical information 5) Promotion of self‐management 6) Patient reminders
Outcomes	Glycated haemoglobin Harms
Funding source	"We would like to thank our funders, the New York University­Health and Hospitals Corporation Clinical and Translational Science Institute (NYU­HHC CTSI) for the 2013 NYU CTSI Pilot Grant and the 2014 HHC H­3 Research Grant award # UL1 TR000038 from the National Center for the Advancement of Translational Science (NCATS), National Institutes of Health. We would also like to thank the HHC Office of Healthcare Improvement for their donation of diabetic testing supplies."
Notes	—
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Patients were randomised on the day of enrollment after the informed consent process. The random allocation sequence was computer‐generated by a co‐investigator and concealed in sequentially numbered envelopes. Patients were stratified by whether they were initiating insulin treatment or having their existing insulin dose adjusted. Within each stratification, the allocation sequence used blocks of 4 to help keep the number of patients balanced in each arm.
Allocation concealment (selection bias)	Low risk	Patients were randomised on the day of enrollment after the informed consent process. The random allocation sequence was computer‐generated by a co‐investigator and concealed in sequentially numbered envelopes. Patients were stratified by whether they were initiating insulin treatment or having their existing insulin dose adjusted. Within each stratification, the allocation sequence used blocks of 4 to help keep the number of patients balanced in each arm.
Patient's baseline characteristics (selection bias)	Low risk	No significant differences in baseline characteristics/demographics were found between the 2 study arms. Demographics of participants are shown in Table 1.
Patient's baseline outcomes (selection bias)	Low risk	Table 1. Means HbA1c are similar between control (12.05 ± 1.91) and intervention (11.43 ± 1.75) at baseline. No significant differences in baseline characteristics/demographics were found between the 2 study arms.
Incomplete outcome data (attrition bias)	High risk	For HbA1c data, 19 patients were lost to follow‐up out of 61 (31%); 14 in the control arm (50%) and 5 in the intervention arm (15%). The large difference between the raw result (of HbA1c) and the multiple imputation result indicates that the missing mechanism was missing‐not‐at‐random and the missing data problem was a limitation of this study for examining HbA1c change. 6 patients (5 in MITI and 1 in usual care) met inclusion criteria when screened at the time of enrollment, but were discovered to be ineligible to participate soon after they consented and were randomised. These 6 patients did not receive the allocated intervention, but were included in the intention‐to‐treat analysis.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias)	Low risk	Our outcome of interest is objective (HbA1c). Patients, clinicians and researchers in this trial were not blinded to arm assignments.
Selective reporting (reporting bias)	Low risk	Prospectively registered protocol (protocol first posted on June 2013, the study started at the same time). All outcomes of interest are reported.
Risk of contamination (other bias)	Low risk	Unlikely control group received treatment as only patients in the intervention arm received SMS and phone call from nurses.
Other bias	Low risk	No evidence of other bias.