We would like to express our gratitude to Lebbar et al. (1) for their interest in our work (2) and for their valuable comments. We value this opportunity to provide a comprehensive response and to clarify the results of our multicenter prospective evaluation of the benefits of two advanced hybrid closed-loop (AHCL) systems in a real-world scenario.
In our discussion, we referred to the authors’ work, published in 2022, which evaluated the outcomes in 75 subjects. We were unable to comment on their follow-up analysis of a larger cohort (3), because this was published on 31 October 2023, after our study had been accepted for publication on 22 October 2023. We thank the authors for bringing their more recent analysis to our attention, and we had read this with interest.
As mentioned by Lebbar et al. (1), both analyses yielded similar improvement in HbA1c with the two evaluated AHCL systems, Medtronic 780G and Control-IQ. Our analysis (2) found no differences in the time in range (TIR) 70–180 mg/dL achieved with the two systems, whereas their study (3) found a greater improvement in 780G users. Besides the limitations inherent to comparing different sensors, there may be several reasons that explain the difference in results between the evaluations.
First, a likely reason is the difference in the study designs, specifically the prospective versus retrospective and multicenter versus single-center designs. Second, there were differences in the baseline treatment between the subjects included in both studies. In our study, 62% of the participants used multiple daily injections, while in the Henry et al. (3) study only pump users were included. Third, our 780G users had age, diabetes duration, HbA1c, and BMI similar to those of the Control-IQ users. In contrast, the Control-IQ users in the Henry et al. study were younger and had shorter diabetes duration, lower HbA1c, and lower BMI. Finally, Henry et al. did not evaluate hypoglycemia awareness, fear of hypoglycemia, diabetes distress, quality of life, or expectancies related to AHCL. This information could have identified specific subpopulations that might have benefited differently from AHCL systems.
We do not believe that the sample size in our study affected our results in the way Lebbar et al. (1) suggest. A sample size calculation was performed to detect a between-group difference in the TIR of 10%, with a prerequisite assignment of 75 subjects to each group of users. In contrast, Henry et al. had 64 participants in the Control-IQ group and 167 in the Medtronic group, a heterogeneity that is inherent to the retrospective design of their study and that could have influenced the results.
Lebbar et al. (1) note an interesting aspect regarding age subgroups in both studies. Our study participants were mostly adults, with 13% <25 years old compared with 33% of participants <25 years old in the Henry et al. study. Further targeted studies are needed to fully explore the benefits of different AHCL systems in patients with diabetes <25 years old.
Our study did not allow for the evaluation of long-term outcomes regarding glucose control. However, previous studies from our group (4), among others, have demonstrated the sustainability of glucose control in the long-term. We did not compare our patient-reported outcomes with those reported in other studies, as this had already been comprehensively evaluated with both systems separately in different populations (5). Additionally, different baseline scores in satisfaction questionnaires in different populations make comparisons between studies unsuitable.
Despite the differences, it is worth noting that both studies support the same conclusion that AHCL systems improve glycemic control in people with type 1 diabetes in a real-world scenario.
Article Information
Duality of Interest. P.I.B.-V. has received speaking/consulting honoraria from Abbott, Novo Nordisk, Medtronic, Roche, Novalab, and Lilly. A.C. reports speaking/consulting honoraria/research support from Abbott, Medtronic, Tandem, Dexcom, Roche, Eli Lilly, Novo Nordisk, Sanofi, Boehringer Ingelheim, and Air Liquide. J.M.-F. reports consultant fees and speaker honoraria from Medtronic, Tandem, Dexcom, Abbott, Roche, and Ypsomed. V.B.-C. has served as a consultant for or received research support, lecture fees, or travel reimbursement from Abbott, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Esteve, Janssen, Merck, Novartis, Novo Nordisk, Roche, and Sanofi. L.N.-C. has received speaking/consulting honoraria from Abbott, Novo Nordisk, Medtronic, Roche, Novalab, and Lilly. M.J.P.-C. has received speaking/consulting honoraria from Roche, Abott, Sanofi, Dexcom Novo Nordisk, and Lilly. M.A.M.-B. has participated as principal investigator in clinical trials financially supported by Medtronic. M.G.-A. has received speaking honoraria from Medtronic. E.A.-H. has received speaking/consulting honoraria from Novo Nordisk, Sanofi, Abbott, and Dexcom. S.A.-M. has acted as a speaker for Amgen, Abbott, Dexcom, Lundbeck, Sanofi, Novo Nordisk, Novartis, Roche, Boehringer Ingelheim Pharmaceuticals, AstraZeneca Pharmaceuticals LP, and Lilly. A.R.-R. has received speaking/consulting honoraria from Abbott, Sanofi, Ascensia, Novo Nordisk, and Lilly. C.Y.-V. has received speaking/consulting honoraria from Medtronic and Lilly. M.P.-C. has received speaking/consulting honoraria from Medtronic, Roche, Abbot, Novalab, Ascensia, Novo Nordisk, and Lilly. N.A. has received consulting honoraria from Medtronic. C.Q. has received speaking/consulting honoraria from Medtronic and Air Liquide. No other potential conflicts of interest relevant to this article were reported.
Handling Editors. The journal editor responsible for overseeing the review of the manuscript was Steven E. Kahn.
