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3 Years of Follow-Up from the COMISAIR Study

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3 Years of Follow-Up from the COMISAIR Study EMERGING TECHNOLOGIES: DATA SYSTEMS AND DEVICES Diabetes Care 1 Jan Soupal,ˇ 1 Lenka Petruzelkovˇ a,´ 2 Glycemic Outcomes in Adults George Grunberger,3,4,5 Aneta Haskov´ a,´ 1 Milan Flekac,ˇ 1 Martin Matoulek,1 With T1D Are Impacted More by Ondˇrej Mikes,ˇ 1 Toma´sˇ Pelcl,1 Jan Skrhaˇ Jr.,1 Eva Horova,´ 1 Jan Skrha,ˇ 1 Continuous Glucose Monitoring Christopher G. Parkin,6 Stˇ epˇ an´ Svacina,ˇ 1 Than by Insulin Delivery Method: and Martin Prazn´ y´1 3 Years of Follow-Up From the COMISAIR Study https://doi.org/10.2337/dc19-0888 OBJECTIVE This study assessed the clinical impact of four treatment strategies in adults with type 1 diabetes (T1D): real-time continuous glucose monitoring (rtCGM) with multiple daily insulin injections (rtCGM1MDI), rtCGM with continuous subcuta- neous insulin infusion (rtCGM1CSII), self-monitoring of blood glucose with MDI (SMBG1MDI), and SMBG with CSII (SMBG1CSII). RESEARCH DESIGN AND METHODS This 3-year, nonrandomized, prospective, real-world, clinical trial followed 94 par- 1 ticipants with T1D (rtCGM1MDI, n 5 22; rtCGM1CSII, n 5 26; SMBG1MDI, n 5 21; 3rd Department of Internal Medicine, 1st Fac- ulty of Medicine, Charles University, Prague, SMBG1CSII, n 5 25). The main end points were changes in A1C, time in range (70– Czech Republic 180 mg/dL [3.9–10 mmol/L]), time below range (<70 mg/dL [<3.9 mmol/L]), 2Department of Paediatrics, 2nd Faculty of Med- glycemic variability, and incidence of hypoglycemia. icine, Charles University, Prague, Czech Republic 3Grunberger Diabetes Institute, Department of Internal Medicine and Center for Molecular RESULTS Medicine & Genetics, Wayne State University At 3 years, the rtCGM groups (rtCGM1MDI and rtCGM1CSII) had significantly lower School of Medicine, Bloomfield Hills, MI 4 A1C (7.0% [53 mmol/mol], P 5 0.0002, and 6.9% [52 mmol/mol], P < 0.0001, Department of Internal Medicine, William Beau- 1 1 mont School of Medicine, Oakland University, respectively), compared with the SMBG CSII and SMBG MDI groups (7.7% Rochester, MI [61 mmol/mol], P 5 0.1.000, and 8.0% [64 mmol/mol], P 5 0.3574, respectively), 5Visiting Professor, 1st Faculty of Medicine with no significant difference between the rtCGM groups. Significant improvements Charles University, Prague, Czech Republic 6 in percentage of time in range were observed only in the rtCGM subgroups CGParkin Communications, Inc., Henderson, NV ˇ (rtCGM1MDI, 48.7–69.0%, P < 0.0001; and rtCGM1CSII, 50.9–72.3%, P < 0.0001) Corresponding author: Jan Soupal, jan.soupal@ seznam.cz and significant reductions in time below range (9.4–5.5%, P 5 0.0287; and 9.0–5.3%, Received 2 May 2019 and accepted 6 August 2019 P 5 0.0325, respectively). Seven severe hypoglycemia episodes occurred: SMBG n 5 n 5 This article contains Supplementary Data online groups, 5; sensor-augmented insulin regimens (SAIR) groups, 2. at http://care.diabetesjournals.org/lookup/suppl/ doi:10.2337/dc19-0888/-/DC1. CONCLUSIONS © 2019 by the American Diabetes Association. rtCGM was superior to SMBG in reducing A1C, hypoglycemia, and other end points in Readers may use this article as long as the work individuals with T1Dregardless of their insulin delivery method. rtCGM1MDI can be is properly cited, the use is educational and not for profit, and the work is not altered. More infor- considered an equivalent but lower-cost alternative to sensor-augmented insulin mation is available at http://www.diabetesjournals pump therapy and superior to treatment with SMBG1MDI or SMBG1CSII therapy. .org/content/license. Diabetes Care Publish Ahead of Print, published online September 17, 2019 2 3-Year Follow-up on COMISAIR Study Diabetes Care Use of real-time continuous glucose either CSII (sensor-augmented pump willingness to participate in a 4-day monitoring (rtCGM) has emerged as a [rtCGM1CSII]) or MDI (rtCGM1MDI)– training program at baseline. Exclusion critical component of diabetes self- on glycemic control compared with criteria were as follows: use of rtCGM management for individuals treated the addition of CSII (SMBG1CSII) or within the previous 3 months, ketoaci- with intensive insulin regimens, and it MDI (SMBG1MDI) (19) among 65 indi- dosis within the previous 3 months, is now considered a standard of care for viduals with T1D. At study end, significant concomitant therapy influencing glu- these patients (1–6). A1C reductions from baseline were ob- cose metabolism, pregnant or plan- Recent randomized clinical trials have served in both the SAIR groups ning pregnancy, and demonstrated demonstrated that use of rtCGM results (rtCGM1CSII: 21.1% [212.0 mmol/ nonadherence to current treatment in significant improvements in glycemic mol], P 5 0.0025; rtCGM1MDI: 21.3% regimen. control and hypoglycemia and confers a [214.2 mmol/mol], P 5 0.0034). Although higher quality of life to participants trea- SMBG1CSII use also led to a significant Procedures ted with multiple daily insulin injections A1C reduction (0.5% [5.5 mmol/mol]), Enrolled participants were scheduled (MDIs) compared with traditional self- no significant reductions were seen in for a total of 15 clinic visits (baseline, monitoring of blood glucose (SMBG) the SMBG1MDI group. The increase at week 2, and then at months 1, 3, 6, 9, (7–11). Similar improvements in A1C from baseline in average number of 12, 15, 18, 21, 24, 27, 30, 33, and 36). A and hypoglycemia have also been ob- boluses per day was significantly greater detailed description of the study proce- served in participants using rtCGM with in the rtCGM1CSII and rtCGM1MDI dures was previously published (19). insulin pump therapy (12,13). Significant groups (3.2 and 2.2, respectively, both At the initial visit, investigators con- reductions in severe hypoglycemia have P , 0.0001) compared with SMBG1CSII firmed eligibility and initiated profes- also been observed in patients with (0.6, P 5 0.08). No increase was seen in sional CGM (iPro2; Medtronic, Northridge, type 1 diabetes (T1D) with problematic the SMBG1MDI group. Importantly, sig- CA) in all participants for 6 days. hypoglycemia who were treated with nificant reductions in percentage of Throughout the study, participants in rtCGM in combination with either MDI time in hypoglycemia (,70 mg/dL [,3.9 the groups not using SAIR had profes- (10) or insulin pump therapy (13). mmol/L]) were observed only in the sional CGM every 3 months. Participants Importantly, a common observation in SAIR groups, from 8 6 4% to 6 6 43%, then attended a structured 4-day train- most rtCGM studies is that glycemic P , 0.01. ing program that addressed basic insulin improvements and other benefits were In the current follow-up study, we administration skills, including timing and dependent upon the persistence of sen- investigated the effects of SAIR interven- dosing of preprandial insulin, prevention sor use (7–15). tions on glycemic control and treatment of hypoglycemia, and theoretical and Although randomized controlled trials persistence among a larger participant practical carbohydrate counting. Par- (RCTs) are recognized as the highest level cohort after 3 years, providing further ticipants were encouraged to use flex- of evidence regarding the efficacy of supportive evidence for the use of rtCGM ible insulin dosing. rtCGM when used within tightly con- in the management of T1D. During training, all treatment mo- trolled settings, our understanding of dalities (rtCGM1MDI, rtCGM1CSII, the real-world use and benefits of rtCGM RESEARCH DESIGN AND METHODS SMBG1MDI, and SMBG1CSII) were in- has been limited. Findings from RCTs The COMISAIR-2 study was the 3-year troduced to participants. In collaboration often fail to reflect actual participant follow-up of the COMISAIR trial (19), with study clinicians, participants se- behaviors and resultant outcomes in which compared the efficacy of the lected their treatment modality accord- real-world clinical practice (16–18). More- long-term use of SAIR regimens among ing to their individual needs and over, there have been few long-term individuals. Participants were recruited preferences. Investigator influence on comparisons to evaluate the efficacy from the participant population treated participant decisions was minimal (6% of rtCGM use in combination with the at the 3rd Department of Internal Med- of cases), and no participant was dis- various insulin delivery methods (e.g., icine, 1st Faculty of Medicine, Charles couraged from using one of the SAIR rtCGM 1 continuous subcutaneous in- University. This report includes results regimens. Participants in the SAIR and sulininfusion[CSII]vs.rtCGM1MDI), and from an additional 29 participants whose CSII groups completed theoretical train- conclusive evidence of rtCGM benefits complete 1-year data were not available ing on the relevant devices, followed by compared with SMBG has been sparse. at the conclusion of the initial COMISAIR treatment initiation and practical train- Because diabetes management is pri- trial. The study was approved by an ing (including insulin adjustment) with marily dependent on participant behav- independent ethics review board and investigators. ior, different research approaches are conducted in accordance with the Dec- Participants using SAIR were encour- needed to more definitively assess these laration of Helsinki (20). All subjects aged to make self-adjustments to their behavior-based interventions. provided written informed consent be- treatment using rtCGM values (hypergly- We recently reported findings from the fore enrollment. cemia and hypoglycemic alerts and Comparison of Sensor Augmented In- Inclusion criteria were as follows: trends) and to incorporate results of sulin Regimens (COMISAIR) study, a 1- age .18 years, .2 years T1D duration, SMBG into treatment changes. Partici- year, nonrandomized, real-world study A1C 7.0–10% (53–86 mmol/mol), treated pants in non-SAIR groups were encour- that assessed the efficacy of long-term with analog insulins, willingness to use aged to measure their blood glucose at use of sensor-augmented insulin regi- sensors .70% of the time or perform least four times per day.
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