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Publications

Journal Article Multicenter Study Observational Study Epublish

PubMed: 42528822 DOI: 10.3389/fendo.2026.1883791

Improvement in insulin injection timing and glucometrics using a connected insulin cap: the prospective study.

Front Endocrinol (Lausanne) 17:1883791

Authors: Fernando Gomez-Peralta, José Miguel Borrachero, Estefanía Santos, Cristina Abreu, Xoán Valledor, Luis Ruiz-Valdepeñas, Rosa Corcoy

Affiliations

  • Endocrinology and Nutrition Unit, Hospital General de Segovia, Segovia, Spain.
  • Centro de Salud del Peral, Cartagena, Spain.
  • Endocrinology and Nutrition Service, Complejo Hospitalario Universitario de Burgos (HUBU), Burgos, Spain.
  • Research and Development Unit, Insulcloud S.L. Madrid, Spain.
  • Institut de Recerca, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
  • Departament de Medicina, Universitat Autònoma de Barcelona, Bellaterra, Barcelona, Spain.
  • Centro de Investigación Biomédica en Red de Bioingeniería, Biomateriales y Nanomedicina (CIBER-BBN), Madrid, Spain.

Abstract

OBJECTIVES

Matching insulin injection timing with meals to optimize postprandial glucose excursions is a daily challenge for individuals with diabetes on a multiple daily injection (MDI) regimen. We aimed to analyze the impact of using a connected insulin pen cap (CIPC) on insulin injection timing and glycemic control.

RESEARCH DESIGN AND METHODS

Pragmatic, real-life, multicenter, prospective, open-label, observational study, including one week of run-in and a 6-week follow-up, split into a two-week masked mode phase and a four-week active phase. Continuous glucose monitoring (CGM) and automatically tracked insulin injection data in individuals with insulin-treated diabetes (ITD) who started using the CIPC Insulclock. The baseline and five hours of paired CGM and rapid-acting insulin data collected from users were analyzed using the ROC detection methodology to identify meal events and the timing of insulin doses.

RESULTS

Of 82 recruited patients, 52 completed the study (54.4 y, 56.6% women, 60.4% with type 1 diabetes [T1D]) across three hospitals and one primary care center in Spain. The CGM glucometrics comparison between the consecutive masked and active phases showed: Glucose Management Indicator (GMI) 8.1 + 1.7 vs 7.8 + 1.4% (-0.3%, p 0.034); Time in Range 70-180 (TIR): 56.9 + 24.5 vs 61.9 + 21.6% (+5.0%, p 0.0054); Time below range <70 (TBR70): 2.5 + 3.3 vs 1.76 + 2.6% (-0.74%, p 0.0015); Time above range >180 (TAR180): 40.9 + 25.3 vs 36.6 + 22.4% (-5.3%, p 0.016). The on-time insulin injections increased: 45.5 + 15.52 to 54.4 + 16.6% (p 0.0017). The timing of insulin injection relative to the post-meal glycemic excursions shifted from +5.6 min (IQR -19.8 to +34.0) in the masked phase (n = 231 events) to -5.9 min (IQR -27.6 to +33.9) in the active phase (n = 467 events) (p = 0.023). An earlier injection was associated with a reduction in TAR180 (p = 0.042). Questionnaires measuring patients' reported outcomes (PROs) indicated a reduction in perceived treatment burden with the use of the CIPC.

CONCLUSIONS

The use of connected insulin pen cap is associated with improved insulin injection timing and glucometrics.

MeSH

Diabetes Mellitus, Injections, Insulin, Meals, Prospective Studies, Endocrine System Diseases