Simplifying meal bolusing with Omnipod 5: real-world outcomes to support simplified user-initiated insulin dosing strategies in managing type 1 or type 2 diabetes.
Jul 2026· Diabetes Research and Clinical Practice· Vol 239, pp.
113450
· 0 citations· 33 references
Medicine
TL;DR
Glycemic outcomes with simplified bolusing were non-inferior to carbohydrate counting, suggesting carbohydrate counting ability should not affect AID access.
Abstract
Aims
Automated insulin delivery (AID) systems typically require user‑initiated meal boluses. This study leveraged real-world data from Omnipod® 5 Automated Insulin Delivery System users to evaluate whether glycemic outcomes using simplified meal bolusing were non-inferior to carbohydrate counting.
Methods
A retrospective analysis of Omnipod 5 users in the US, UK, France, and Germany from 01/01/25 - 31/03/25 was conducted. Carbohydrate counting or simplified bolusing categorization was based on the proportion of boluses that used each individual's top five carbohydrate entries. The primary comparison used quantile regression and adjusted for users' characteristics and device settings/usage.
Results
The overall cohort included 195,529 individuals (92 % T1D). In T1D, simplified bolusing was associated with 2.5 % lower time in range (TIR) 70-180 mg/dL, 0.19 % lower time below range (TBR) < 70 mg/dL, and 5 mg/dL higher mean glucose compared with carbohydrate counting. All endpoints met noninferiority, with similar findings across age groups and countries. In T2D, differences were - 1.7 % for TIR, -0.05 % for TBR, and + 4 mg/dL for mean glucose, also meeting noninferiority. Among those using optimized settings and expected use patterns, T1D maintained noninferiority and T2D met noninferiority for TBR only.
Conclusions
Glycemic outcomes with simplified bolusing were non‑inferior to carbohydrate counting, suggesting carbohydrate counting ability should not affect AID access.
BACKGROUND
Carbohydrate counting (CC) is challenging and may be a barrier to automated insulin delivery (AID) use. Given the ability of AID to modulate insulin delivery, a simpler meal bolus strategy may be adequate for glycemic management.
METHODS
Participants aged 14-26 using AID were enrolled in a randomized crossover trial comparing glycemic management using simple boluses versus CC for 4 weeks each. Before the simple period, participants were educated to enter a set carbohydrate amount for a small (30 g), medium (60 g), or large (90 g) meal, and carbohydrate ratios were standardized. Glycemic outcomes were compared between study periods. We hypothesized that time in range (TIR) 70-180 mg/dL would not be inferior by more than 5% during the simple period compared with the CC period. Other measures of glycemia were compared using paired t-tests.
RESULTS
Among 31 participants (17.4 years; 51.6% female; type 1 diabetes duration [T1DDur.] 8.3 years; baseline TIR 64.1%), TIR with simple meal boluses was not inferior to TIR with CC (simple TIR 64.2%, CC TIR 66.0%, difference -1.8%, lower limit of 95% confidence interval: -3.9, P = 0.008 indicating noninferiority at a margin of Δ = 5). There were no differences in % time >250 mg/dL (difference 1.2%, P = 0.3) and % time <70 mg/dL (difference -0.02%, P = 0.9). After the study, 31.3% of participants preferred CC, 40.6% preferred simple boluses, and 28.1% preferred their prestudy method.
CONCLUSION
Precise CC may be an unnecessary burden for T1D adolescents using AID, and requiring it could impact success with or access to these systems. Using a simple meal bolus strategy is one option to reduce burden without significant impact on glycemic outcomes (Clinical Trials Registration number- NCT06575790).
Alexandra Sawyer, Lindsey Towers, Samantha Lange et al.· Diabetes Technology & Therap...· 0 citations
ABSTRACT Aims To evaluate the efficiency of the AID system with Control‐IQ technology and carbohydrate counting (CHC)–based premeal bolus to control postprandial glucose (PPG) after mixed meals with different macronutrient compositions in adolescents with type 1 diabetes (T1D). Material and Methods In this prospective crossover study, 25 adolescents with T1D using an automated insulin delivery (AID—Tandem Tslim X2 with Control‐IQ) consumed three iso‐caloric meals (745 kcal) on separate days: a standard meal (56.5% carbohydrate), a high‐fat (HF) meal (45.9% fat), and a high‐protein (HP) meal (24.4% protein). A CHC‐based bolus was administered 15 min before each meal. Continuous glucose monitoring metrics and AID insulin delivery were assessed over 6 h. The primary outcome was 6‐h time in range (TIR, 70–180 mg/dL). Results Six‐hour TIR was significantly lower after HF (65.2%) and HP meals (49.9%) compared with the standard meal (84.3%) (p < 0.01 and p < 0.001, respectively). Postprandial glucose exposure (AUC above 140 and 180 mg/dL) was significantly higher after HF and HP meals at both 3 and 6 h. The AID system delivered significantly more insulin than the pre‐programmed basal for HF (+26% at 6 h, p < 0.05) and HP meals (+55% at 6 h, p < 0.001), without increasing hypoglycemia. Conclusions Despite a substantial autonomous increase in insulin delivery, AID systems using Control‐IQ technology and a standard CHC‐based pre‐meal bolus have not achieved adequate postprandial glycemic control after HF and HP meals. Proactively timed, meal‐specific insulin strategies are required to improve postprandial outcomes after nutritionally complex meals.
M. Marigliano, Claudia Piona, Elisa Morotti et al.· Diabetes, obesity and metabo...· 0 citations
To evaluate efficacy and safety of continuous glucose monitoring (CGM) and automated insulin delivery (AID) in infants. A retrospective multicenter study (13 centers) of 76 children diagnosed with antibody-positive type 1 diabetes before age 2. Outcomes at 12 months were compared between AID users (n = 47) and multiple daily injections (MDI)/SAP users (n = 29). AID systems included Medtronic 780 G (38%), Tandem Control-IQ (38%), and CamAPS FX (24%). CGM median wear time was 97.0% (93.3; 98.1). AID users achieved significantly higher TIR (65% vs. 56%, P = 0.041) and time in tight range (TITR) (42% vs 32.5%, P = 0.038). In multivariable regression, AID was the sole independent predictor of lower HbA1c (P = 0.035). Zero severe hypoglycemia (SH) events occurred in the AID group (vs. 7.1% in MDI/SAP). Use of CGM is safe in very young children, with AID systems proving superior to traditional therapy. This real-world evidence supports incorporating AID consideration into future international guidelines from the time of pediatric diagnosis.
M. Marigliano, A. Scaramuzza, C. Arnaldi et al.· Diabetes Technology & Therap...· 0 citations
Introduction Diabetes self-management in older adults with type 1 diabetes (T1D) presents a unique clinical challenge, since maintaining tight glycemic control must be carefully weighed against age-related vulnerabilities. This study aimed to analyze glycemic control through the effects of customized algorithm settings in a cohort of older adults with T1D using an automated insulin delivery (AID) system. Methods This retrospective real-world data analysis included users of the MiniMed™ 780G AID system, aged ≥60 years. Continuous glucose monitoring (CGM) data including time in range (TIR; 70–180 mg/dL; 3.9–10.0 mmol/L), time in tight range (TITR; 70–140 mg/dL; 3.9–7.8 mmol/L), time below range (TBR; <70 mg/dL; <3.9 mmol/L), level 2 TBR (<54 mg/dL; <3.0 mmol/L) and time above range (TAR; >180 mg/dL; >10.0 mmol/L) were analyzed alongside algorithm settings and daily insulin use. Group comparisons utilized standard parametric and non-parametric statistical tests. A multivariable logistic regression model identified independent clinical predictors of high glycemic performance (TITR ≥50%). Results The cohort comprised 97 AID users (70.1% female, mean age 67.9 ± 6.7; range 60–90 years). Overall glycemic control was good, with mean TIR 76.1%, TITR 51.1% and TBR 1.1%. Fourteen participants (14.4%) used the manufacturer’s recommended optimal settings (ROS); i.e., target glucose of 5.5 mmol/L and active insulin time of 2 hours. CGM metrics did not differ between ROS and non-ROS users for TIR, TITR and TBR. When stratifying the cohort by glycemic performance, 55 participants (56.7%) reached TITR ≥50%; however, the adoption of ROS in high (≥50%) TITR and lower (<50%) TITR subgroups was similar (16.4% vs 11.9%; Fisher p=0.58). When compared to the lower TITR subgroup, participants in the high TITR subgroup delivered less auto-correction insulin (14.2% vs 20.6%, p<0.001) and a higher proportion of manual bolus insulin (46.1% vs 35.2%, p<0.001), which remained a significant predictor of high TITR after multivariable adjustment. TBR was significantly higher in the high (≥50%) TITR subgroup, although it remained low in absolute terms (1.5% vs. 0.8%; p=0.017). Conclusion While the MiniMed™ 780G AID system use is associated with low CGM-derived hypoglycemia exposure and highly effective glycemic control, regardless of customized settings, superior glycemic control is associated with a higher proportion of user-initiated manual boluses. The algorithm supports, but cannot replace, user engagement.
Š. Volčanšek, P. Vidmar, A. Janež et al.· Frontiers in Endocrinology· 0 citations
ABSTRACT Background The Omnipod 5 Automated Insulin Delivery (AID) System is safe and effective for individuals managing Type 1 diabetes (T1D). Longer‐term studies may provide additional evidence of sustained effectiveness and safety of AID system use in T1D. Methods This 12‐month extension study was conducted following a multicenter randomized controlled trial (RCT) where participants used either AID (Omnipod 5) or standard therapy (current non‐automated pump therapy) for 13 weeks. Participants in France (n = 76) could transition to or continue with AID for an additional 12 months. Glycemic, safety, and psychosocial outcomes during or at the end of the extension phase were compared with baseline or end of RCT, as appropriate. Results Seventy‐five participants enrolled in the extension phase. From RCT baseline to the end of the extension phase, time in range 70–180 mg/dL increased by 17.9% (p < 0.0001) or 4.3 h/day to 62.3%. Time above range > 180 mg/dL and mean sensor glucose decreased by 17.7% and 27.8 mg/dL (both p < 0.0001), respectively. HbA1c decreased from 8.33% to 7.18% (−1.14%; p < 0.0001). Glycemic improvements were maintained for those continuing with AID from the RCT intervention group and for those transitioning to AID from standard therapy. Diabetes Quality of Life‐brief and Hypoglycemia Confidence Scale scores were maintained or improved at 6 and 12 months compared to RCT baseline. Adverse events were infrequent (12 per 100 person‐years). Conclusions Findings support the RCT results, demonstrating safety and sustained improvements in glycemic and psychosocial outcomes with the Omnipod 5 System in adults in France with T1D over 12 months. Trial Registration: ClinicalTrials.gov NCT05409131
Éric Renard, Ruth S. Weinstock, A. Penfornis et al.· Endocrinology, Diabetes & Me...· 0 citations
Active insulin time is a key modifiable parameter influencing AB delivery and glycemic outcomes, and shorter AIT settings were associated with increased AB administration and improved TIR, whereas glucose target settings had no significant impact on these outcomes.
Giuseppe Papa, R. Cannarella, C. Gusmano et al.· Journal of Diabetes Science...· 0 citations
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