Efficacy and Safety of a Decision Support Intervention for Basal Insulin Self-Titration Assisted by the Nurse in Outpatients with T2DM: A Randomized Controlled Trial

Abstract

Objective The main aim of this study was to evaluate a combined fasting blood glucose based dosage self-titration setting and decision supported telephone coaching intervention on glycemic control and diabetes self-management skills, compared to the conventional care. Methods A 12-week, single-blinded, randomized controlled trial was conducted on adults with type 2 diabetes (T2DM) primarily treated with basal insulin. After randomization, the intervention group (IG, n = 426) received a basal insulin self-titration decision support intervention administered by the Diabetes Specialty Nurses while the control group (CG, n = 423) received conventional care for 12 weeks, both included five telephone interviews. The primary efficacy endpoint was the effect of intervention on glycemic control, measured as the change in glycated hemoglobin (HbA1c) from baseline to Week 12 (after intervention) compared to the control group. Other endpoints included comparisons of the effects of intervention on fasting plasma glucose (FPG), postprandial plasma glucose (PPG), body weight, Michigan diabetes knowledge test (MDKT), diabetes empowerment scale-short Form (DES-DSF), and summary of diabetes self-care activities (SDSCA). Changes in the primary and secondary outcomes were compared using the t -test for continuous variables with a normal distribution and χ 2 -test for categorical variables. Results The IG showed more improvements on mean HbA1c, compared to the CG (−2.8% vs −1.8%), so did the FPG, PPG, MDKT, DES-DSF and SDSCA (all P<0.01) after the 12-week follow up. Though the final mean insulin dose in the IG was higher than the CG at the end of the study (0.32 U/kg vs 0.28 U/kg), the changes of body weight were similar between the two groups (0.46kg vs 0.40kg, P=0.246), and the proportion of patients with hypoglycemia events during the whole trial were similar (20.65% vs 17.73%, P=0.279). Conclusion Decision supporting of basal insulin glargine self-titration assisted by Diabetes Specialty Nurses is effective and safe in patients with T2DM. Decision supported telephone coaching intervention offers ongoing encouragement, guidance, and determination of relevant sources of decisional conflict, facilitating adjusting the insulin dose.

Time for Using Machine Learning for Dose Guidance in Titration of People With Type 2 Diabetes? A Systematic Review of Basal Insulin Dose Guidance

“…Twenty-one of identified dose guidance methods were developed for titration of glargine (30,32,34,(36)(37)(38)(39)41,42,44,45,47,49,51,(53)(54)(55)(56)58,61,62) , three for detemir (40,48,52) , five for degludec (8,10,31,43,46) , one for icodec (50) , and one for glargine and detemir (59) . Four studies did not specify insulin further than it was basal insulin analogs (33,35,57,60) .…”

“…Telehealth solutions covered telemonitoring solutions with titration across a digital platform (30,45,54,57,59,60) and combined with home visits (35) , or self-titration decision support (33,39,44,47,55) . In contrast to studies addressing paper-based algorithms, the organizational setup was altered in these studies.…”

“…In total, 12 studies investigated telehealth solutions (30,33,35,39,44,45,47,54,55,57,59,60) . Mathematical models were investigated by three studies using used compartment modeling and control theory (8,10,31) .…”

“…Decision support system for self-titration using the 4-2-0-2- 2010 (47) Decision support system for self-titration using the 4-2-0-2-4-6 titration algorithm to the target 79-119 mg/dL. (39) Self-titration decision support program.…”

“…The most significant difference was whether participants were insulin naïve at start-of-trial. Study population in 60% of the studies were insulin naïve (8,10,31,34,35,37,(39)(40)(41)45,46,(48)(49)(50)(51)53,(56)(57)(58)61,62) . In 14% of studies, the population continued basal insulin treatment initiated before the study (30,32,33,36,43) , and 26% of studies included a study population of both insulin naïve and continuers (38,42,44,47,52,54,55,59,60) .…”