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AIM: To report on the effectiveness and safety of the MiniMed 780G automated insulin delivery system in real-world users during the month of Ramadan. MATERIALS AND METHODS: CareLink Personal data were extracted from MiniMed 780G system users from the Gulf region. Users were included if they had ≥10 days of sensor glucose data during the month of Ramadan 2022 as well as in the month before and after. For the main analysis, continuous glucose monitoring endpoints were aggregated per month and were reported by time of day (daytime: 05.31-18.00 h, and night-time). Additional analyses were performed to study the pace at which the algorithm adapts. RESULTS: Glycaemic control was well kept in the 449 included users (mean sensor glucose = 152.6 ± 18.7 mg/dl, glucose management indicator = 7.0 ± 0.4%, time in range = 70.7 ± 11.0%, time below 70 mg/dl = 2.3 ± 2.3%). Albeit some metrics differed from the month before (p < .0001 for all), absolute differences were very small and considered clinically irrelevant. During Ramadan, there was no increased risk of hypoglycaemia during daytime (time below 70 mg/dl = 2.3 ± 2.4%), time in range was highest during daytime (80.0 ± 10.7%, night: 60.4 ± 15.3%), while time above 180 mg/dl was highest during night-time (37.3 ± 16.3%, day: 17.7 ± 10.7%). The algorithm adapted immediately upon lifestyle change. CONCLUSION: The MiniMed 780G automated insulin delivery system is effective, safe and fast in adapting to the substantial changes that occur in the lifestyle of people with type 1 diabetes during Ramadan.
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Diabetes Mellitus Tipo 1 , Hipoglucemia , Humanos , Insulina/efectos adversos , Glucemia/análisis , Automonitorización de la Glucosa Sanguínea , Diabetes Mellitus Tipo 1/tratamiento farmacológico , Hipoglucemia/inducido químicamente , Hipoglucemia/epidemiología , Hipoglucemia/prevención & control , Insulina Regular Humana/uso terapéutico , Sistemas de Infusión de Insulina/efectos adversos , Hipoglucemiantes/efectos adversosRESUMEN
OBJECTIVE: We studied time in tight range (TITR) (70-140 mg/dL) in real-world users of the MiniMed 780G system (MM780G). RESEARCH DESIGN AND METHODS: CareLink Personal data were extracted (August 2020 to December 2022) to examine TITR and its relationship with time in range (TIR; 70-180 mg/dL), factors predicting higher TITR, and which TITR target is a reasonable treatment goal. RESULTS: The 13,461 users (3,762 age ≤15 years and 9,699 age >15 years) showed an average TITR of 48.9% in those age ≤15 years and 48.8% in the older group (vs. TIR 71.2% and 73.9%, respectively). Consistent use of a glucose target (GT) of 100 mg/dL and active insulin time (AIT) of 2 h were the most relevant factors predicting higher TITR (P < 0.0001). In users consistently applying these optimal settings, TITR was 56.7% in those age ≤15 years and 57.0% in the older group, and the relative impact of these settings on TITR was 60% and 86% greater than that on TIR, respectively. TITRs of â¼45% (age ≤15 years 46.3% and older group 45.4%), â¼50% (50.7% and 50.7%) and â¼55% (56.4% and 58.0%) were best associated with glucose management indicators <7.0%, <6.8%, and <6.5%, respectively. TITRs of >45%, >50%, and >55% were achieved in 91%, 74%, and 55% of those age ≤15 years and 93%, 81%, and 57% of older group users, respectively, at optimal settings. CONCLUSIONS: This study demonstrates that 1) mean TIR is high with a high mean TITR in MM780G users (>48%), 2) consistent use of optimal GT/AIT improves TITR (>56%), 3) the impact of these settings on TITR is larger than on TIR, and 4) a TITR target >50% is our suggested treatment goal.
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Diabetes Mellitus Tipo 1 , Humanos , Adolescente , Diabetes Mellitus Tipo 1/tratamiento farmacológico , Glucosa , Glucemia , Automonitorización de la Glucosa Sanguínea , Insulina/uso terapéutico , HipoglucemiantesRESUMEN
The concept of maintaining blood glucose levels within the 70-180 mg/dL range, known as time-in-range, has raised questions regarding its representation of true physiological euglycemia. Some have speculated that focusing on the time spent within the 70-140 mg/dL range, introduced as time in tight range (TITR) through the International Consensus statement, could serve as a more precise metric for assessing normoglycemia in individuals with type 1 diabetes. This article delves into the current status of TITR as an emerging marker and explores how advanced hybrid closed-loop systems may offer a promising avenue for achieving this higher level of glycemic control.
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Diabetes Mellitus Tipo 1 , Hipoglucemiantes , Humanos , Hipoglucemiantes/uso terapéutico , Insulina/uso terapéutico , Objetivos , Sistemas de Infusión de Insulina , Diabetes Mellitus Tipo 1/tratamiento farmacológico , Glucemia , Automonitorización de la Glucosa SanguíneaRESUMEN
Introduction: The present report celebrates the benchmarking of 100,000 MiniMed™ 780G system users in Europe, Middle East, and Africa (EMEA) and summarizes the major insights into the usability and outcomes of this system. Methods: Carelink Personal data (August 2020-August 2023) of users living in EMEA were analyzed. Continuous glucose monitoring-based endpoints were aggregated for (1) the full cohort and (2) a 12-month longitudinal cohort. Subanalyses were done for users on optimal settings (those spending ≥95% of time with glucose target of 100 mg/dL, and ≥95% of time with active insulin time of 2 h), for self-reported age groups (≤15 and ≥56 years) and for various countries/regions. Results: Data from 101,629 users (34 countries) were analyzed. Mean time in range (TIR) was 72.3%, glucose management indicator (GMI) was 7%, time below 70 mg/dL (TBR70) was 2.0% and time below 54 mg/dL (TBR54) was 0.4%. In terms of international targets, 59.6% of users achieved a GMI <7%, 62.5% a TIR >70%, 88.4% a TBR70 < 4%, and 90.0% a TBR54 < 1%. Data improved impressively in optimal setting users (TIR = 78.8%, and users reaching TIR >70% = 86.3%) while safety remained (TBR70 = 2.2% and TBR54 = 0.4%). Data showed consistency across self-reported age groups and geographies. In the longitudinal cohort, TIR reached 75.5% in the first month and remained 73.3% or higher over the 12-month period. Conclusion: Over 100,000 users of the MiniMed™ 780G system have demonstrated consistency in achieving target control of glycemia.
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Automonitorización de la Glucosa Sanguínea , Diabetes Mellitus Tipo 1 , Humanos , Persona de Mediana Edad , Glucemia , África , Medio Oriente , Europa (Continente) , Glucosa , Insulina/uso terapéutico , Hipoglucemiantes , Sistemas de Infusión de InsulinaRESUMEN
BACKGROUND: The aim of the study was to analyze the real-world performance of MiniMed 780G (MM780G) Advanced Hybrid Closed Loop (AHCL) system users from Poland (PL) and compare it to the European region excluding Poland (EU-PL) in order to identify factors contributing to potential differences. The former achieved some of the best Time in Range (TIR) results globally using this technology. METHODS: CareLink Personal data uploaded by MM780G system users from August 2020 to December 2022 were analyzed. RESULTS: The Polish users (N=1304) on average reached to TIR of 79.1⯱â¯8.7â¯% (vs 73.0⯱â¯10.0â¯% for EU-PL, N=55659), a TBR<54â¯mg/dL of 0.6⯱â¯0.7â¯% (vs 0.4⯱â¯0.6â¯%) and a TBR<70â¯mg/dL of 2.9⯱â¯2.1â¯% (vs 2.1⯱â¯1.8â¯%). The adoption rate of optimal settings (i.e, GT=100â¯mg/dL, AIT=2hr) in PL was high (19.7â¯% vs 6.3â¯%), and filtering on optimal setting users led to less pronounced differences in glycemic control between PL and EU-PL. A univariable analysis with post-AHCL TIR showed that geography itself (PL vs EU-PL) is not a significant contributor to a high post-AHCL TIR (pâ¯=â¯0.15), and that much of the Polish post-AHCL TIR can be explained by the high pre-AHCL TIR. CONCLUSION: The Polish MM780G users achieved better glycemic control than the general European population (excluding Poland). This is largely attributable to the adoption of optimal settings in Poland and the already high glycemic outcomes at system start. As these characteristics can be implemented elsewhere, we believe this outstanding result can be obtained in other countries as well.
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INTRODUCTION: This article offers a systematic literature review (SLR) on the use of the MiniMed 780G automated insulin delivery system (MM780G) in people with type 1 diabetes (PwT1D) during Ramadan intermittent fasting. It also presents consensus recommendations on the use of MM780G during the Ramadan period. METHODS: The SLR was performed following PRISMA methodology. The recommendations resulted from a consensus-forming process involving a panel of experts. The process considered evidence found in the SLR as well as the expert opinions. RESULTS: In total, 6 studies were included in the SLR. The evidence and expert opinions led to recommendations related to a) pre-Ramadan counseling of MM780G users who plan to fast, b) suggested MM780G settings, meal announcement strategy and safety aspects during Ramadan (including a contingency plan), and c) post-Ramadan transition into and out of Eid-al-Fitr festivities. DISCUSSION: The SLR findings showed that the MM780G maintain glycemic control at target in PwT1D during Ramadan (meeting CGM-based clinical targets proposed by the International Consensus on Time-in-Range) while ensuring low rates of hypoglycemia and diabetic ketoacidosis. Automated insulin delivery also helps PwT1D fast more days of Ramadan compared to users of other less advanced modalities of treatment. Pre-Ramadan guidance on specific aspects of the MM780G along with IDF-DAR counseling guidelines are recommended. There is still a challenge with post-Iftar hyperglycemia, which could potentially be mitigated by following the recommendations outlined in this article.