Transition of a Text-Based Insulin Titration Program From a Randomized Controlled Trial Into Real-World Settings: Implementation Study

Abstract

BackgroundThe Mobile Insulin Titration Intervention (MITI) program helps patients with type 2 diabetes find their correct basal insulin dose without in-person care. Requiring only basic cell phone technology (text messages and phone calls), MITI is highly accessible to patients receiving care in safety-net settings. MITI was shown in a randomized controlled trial (RCT) to be efficacious at a New York City (NYC) safety-net clinic where patients often have challenges coming for in-person care. In 2016, MITI was implemented as usual care at Bellevue Hospital (the site of the original RCT) and at Gouverneur Health (a second NYC safety-net clinic) under 2 different staffing models.ObjectiveThis implementation study examined MITI’s transition into real-world settings. To understand MITI’s flexibility, generalizability, and acceptability among patients and providers, we evaluated whether MITI continued to produce positive outcomes in expanded underserved populations, outside of an RCT setting.MethodsPatients enrolled in MITI received weekday text messages asking for their fasting blood glucose (FBG) values and a weekly titration call. The goal was for patients to reach their optimal insulin dose (OID), defined either as the dose of once-daily basal insulin required to achieve either an FBG of 80-130 mg/dL (4.4-7.2 mmol/L) or as the reaching of the maximum dose of 50 units. After 12 weeks, if OID was not reached, the patients were asked to return to the clinic for in-person care and titration. MITI program outcomes, clinical outcomes, process outcomes, and patient satisfaction were assessed.ResultsMITI was successful at both sites, each with a different staffing model. Providers referred 170 patients to the program—129 of whom (75.9%, 129/170) were eligible. Of these, 113 (87.6%, 113/129) enrolled. Moreover, 84.1% (95/113) of patients reached their OID, and they did so in an average of 24 days. Clinical outcomes show that mean FBG levels fell from 209 mg/dL (11.6 mmol/L) to 141 mg/dL (7.8 mmol/L), P<.001. HbA1c levels fell from 11.4% (101 mmol/mol) to 10.0% (86 mmol/mol), P<.001. Process outcomes show that 90.1% of MITI’s text message prompts received a response, nurses connected with patients 81.9% of weeks to provide titration instructions, and 85% of attending physicians made at least one referral to the MITI program. Satisfaction surveys showed that most patients felt comfortable sharing information over text and felt the texts reminded them to take their insulin, check their sugar, and make healthy food choices.ConclusionsThis implementation study showed MITI to have continued success after transitioning from an RCT program into real-world settings. MITI showed itself to be flexible and generalizable as it easily fits into a second site staffed by general medical clinic–registered nurses and remained acceptable to patients and staff who had high levels of engagement with the program.

Barriers and Facilitators to the Implementation of a Mobile Insulin Titration Intervention for Patients With Uncontrolled Diabetes: A Qualitative Analysis

“…The sociodemographics and program outcomes of the patient interview sample are shown in Table 1. The characteristics of the interview sample were similar to those in the broader MITI sample [10]. Participants at both sites were predominantly male, on average aged 49 to 51 years, and most reported Hispanic ethnicity.…”

“…Physicians could refer patients with uncontrolled diabetes who needed adjustment of their basal insulin to MITI during a routine clinical visit (full patient eligibility criteria are described elsewhere [10]). At Bellevue, physicians referred the patients to MITI by paging an onsite program coordinator who met the patient to complete enrollment.…”

“…Every Thursday afternoon a nurse would call each MITI patient to provide dosing instructions using an algorithm [8,10] developed by the MITI clinical director (NL). At Bellevue, the daily FBG monitoring and Thursday titration calls were completed by the clinic’s two diabetes nurse educators (DNEs) who had protected time to deliver the MITI intervention.…”

“…On the basis of the success of the RCT, Bellevue Hospital and a second NYC Health + Hospitals facility (Gouverneur Health) implemented the MITI program into routine care. To accelerate the future translation of MITI in other settings, we conducted a mixed-methods hybrid effectiveness implementation study evaluating the implementation of MITI as it moved from the RCT into usual care [9,10]. The study’s quantitative analysis showed that MITI was effective as routine care, with 84% of MITI patients reaching their OID in an average of 24 days [9].…”

Outcomes of a feasibility trial using an innovative mobile health programme to assist in insulin dose adjustment

“…As with the mobile insulin titration intervention study, we are now transitioning the mIDA programme to an implementation trial for understanding generalisability and acceptability among patients and providers 16. As technology advances, innovative solutions like patient facing-apps/devices that guide self-titration of insulin through automated prompts with support from healthcare providers will become increasingly available and might be even more cost-effective 6…”