Implementation of Basal–Bolus Therapy in Type 2 Diabetes: A Randomized Controlled Trial Comparing Bolus Insulin Delivery Using an Insulin Patch with an Insulin Pen

Abstract

Background: Barriers to mealtime insulin include complexity, fear of injections, and lifestyle interference. This multicenter, randomized controlled trial evaluated efficacy, safety, and self-reported outcomes in adults with type 2 diabetes, inadequately controlled on basal insulin, initiating and managing mealtime insulin with a wearable patch versus an insulin pen. Methods: Adults with type 2 diabetes ( n = 278, age: 59.2 ± 8.9 years), were randomized to patch ( n = 139) versus pen ( n = 139) for 48 weeks, with crossover at week 44. Baseline insulin was divided 1:1 basal: bolus. Using a pattern-control logbook, subjects adjusted basal and bolus insulin weekly using fasting and premeal glucose targets. Results: Glycated hemoglobin (HbA1c) change (least squares mean ± standard error) from baseline to week 24 (primary endpoint) improved ( P < 0.0001) in both arms, −1.7% ± 0.1% and −1.6% ± 0.1% for patch and pen (−18.6 ± 1.1 and −17.5 ± 1.1 mmol/mol), and was maintained at 44 weeks. The coefficient of variation of 7-point self-monitoring blood glucose decreased more ( P = 0.02) from baseline to week 44 for patch versus pen. There were no differences in adverse events, including hypoglycemia (three severe episodes per arm), and changes in weight and insulin doses. Subject-reported treatment satisfaction, quality of life, experience ratings at week 24, and device preferences at week 48 significantly favored the patch. Most health care providers preferred patch for mealtime insulin. Conclusions: Bolus insulin delivered by patch and pen using an algorithm-based weekly insulin dose titration significantly improved HbA1c in adults with type 2 diabetes, with improved subject and health care provider experience and preference for the patch.

Randomized Double-Blind Clinical Trial Comparing Ultra Rapid Lispro With Lispro in a Basal-Bolus Regimen in Patients With Type 2 Diabetes: PRONTO-T2D

“…Several studies have shown that introducing a prandial insulin as part of a basal-bolus regimen in type 2 diabetes is more effective than a basal-only regimen at improving HbA 1c , as it provides postprandial insulin coverage (6)(7)(8)(9). For optimal postprandial glucose (PPG) control, an ideal prandial insulin should match carbohydrate absorption by demonstrating faster absorption, more rapid onset, and shorter duration of action.…”

Practical application of short-term intensive insulin therapy based on the concept of “treat to target” to reduce hypoglycaemia in routine clinical site

“…Many treatment algorithms and clinical trials of T2DM with beta cell death have been proposed so far [31][32][33][34] . Basal-Bolus, Basal plus, Basal supporting oral therapy (BOT), premixed insulins and premixed insulin and GLP-1R agonist were reported to improve safety and efficacy of the patient treated mainly in out-patient clinic [35][36][37][38][39][40][41][42] .…”

The burden of type 2 diabetes in Europe: Current and future aspects of insulin treatment from patient and healthcare spending perspectives

“…A recent study comparing mealtime insulin patches and insulin pens observed comparable improvement in HbA1c, FPG, total daily insulin dose, basal insulin dose, body weight, and hypoglycaemic episodes. Patient reported outcomes slightly favoured patches with significantly increased overall satisfaction and ease of use [63]. However, currently the size of the insulin reservoirs may be considered a limitation of these insulin delivery patches.…”

“…Even though clinical inertia may be strongly patient driven, it must not be neglected that HCPs also face certain barriers to initiate insulin therapy. These may include lack of time, resources, cost or insufficient experience/expertise with insulin therapy and/or insulin delivery devices [63]. An international survey confirmed that the main barriers for the initiation of insulin therapy include the lack of experience of HCPs with the available insulin preparations and lack of time available for patient education [64].…”

“…Wearable mealtime insulin delivery patches are mechanical patches attached to the abdomen which allows easy on-demand bolus subcutaneous insulin delivery [63]. Current bolus insulin patches can be worn for between 1 and 3 days and reduce the burden of transporting medication [41].…”