Search

Continuous subcutaneous insulin infusion (CSII) therapy is becoming increasingly popular. CSII provides convenient insulin delivery, precise dosing, easy adjustments for physical activity, stress, or illness, and integration with continuous glucose monitors in hybrid or other closed-loop systems. However, even as insulin pump hardware and software have advanced, technology for insulin infusion sets (IISs) has stayed relatively stagnant over time and is often referred to as the "Achilles heel" of CSII. To discuss barriers to insulin pump therapy and present information about advancements in, and results from clinical trials of extended wear IISs, Diabetes Technology Society virtually hosted the "Improving the Patient Experience with Longer Wear Infusion Sets Symposium" on December 1, 2021. The symposium featured experts in the field of IISs, including representatives from Steno Diabetes Center Copenhagen, University of California San Francisco, Stanford University, Medtronic Diabetes, and Science Consulting in Diabetes. The webinar's seven speakers covered (1) advancements in insulin pump therapy, (2) efficacy of longer wear infusion sets, and (3) innovations to reduce plastics and insulin waste.

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 ∼45% (age ≤15 years 46.3% and older group 45.4%), ∼50% (50.7% and 50.7%) and ∼55% (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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Introduction: Insulin requirement in women with Type 1 diabetes (T1DM) changes throughout pregnancy. The aim of this study was to determine the total change in insulin requirements and the effect of gestational weight gain (GWG) and pre‐gestational BMI on insulin requirements during pregnancy in women with T1DM treated with continuous subcutaneous insulin infusion and continuous glucose monitoring. Methods: This historical cohort study included all consecutive women with T1DM who were monitored during pregnancy at the high‐risk pregnancy clinic at a tertiary medical center during April 2011–April 2019. One Way Repeated Measures ANOVA with Bonferroni adjustment was conducted to compare the effects of gestational age on insulin requirements and a Two Way Repeated Measures ANOVA was employed to test for the interaction between gestational age intervals and maternal BMI and GWG. Results: Data regarding insulin requirements of 185 pregnancies were included in the analyses. There was a significant effect of gestational age on total insulin (Wilks' Lambda = 0.34, F(6,14) = 4.52, p = 0.009), basal insulin (Wilks' Lambda = 0.41, F(6,14) = 3.30, p = 0.031) and bolus insulin (Wilks' Lambda = 0.43, F(6,14) = 3.02, p = 0.041). Total insulin/kg requirements increased by 5.5% from 13–20 weeks to 20–26 weeks, 19% from 20–26 weeks to 26–33 weeks, and 17.4% from 26 to 33 weeks to delivery (p for trend = 0.009). Overall, insulin requirements increased by 42.1% from conception to delivery (p < 0.01). There was no significant main effect of maternal BMI or GWG on insulin requirements. Conclusions: There is a significant increase in insulin requirements per kg during pregnancy in women with T1DM who were treated with an insulin pump. [ABSTRACT FROM AUTHOR]

Aims: To reassess the 6‐month efficacy and to assess the 12‐month sustained efficacy of the MiniMed™ 780G advanced hybrid closed‐loop automated insulin delivery (AID) system compared to multiple daily injections plus intermittently scanned glucose monitoring (MDI+isCGM) in people with type 1 diabetes not meeting glucose targets. Methods: The ADAPT study was a prospective, multicentre, open‐label, randomized control trial in people with type 1 diabetes, with a glycated haemoglobin (HbA1c) concentration of at least 8.0% (64 mmol/mol), on MDI+isCGM therapy. After a 6‐month study phase, participants randomized at baseline to MDI+isCGM switched to AID (SWITCH) while the others continued AID therapy (SUSTAIN) for an additional 6 months. The primary endpoint of this continuation phase was the within‐group change in mean HbA1c between 6 and 12 months, with superiority in the SWITCH group and noninferiority in the SUSTAIN group (ClinicalTrials.gov: NCT04235504). Results: A total of 39 SWITCH and 36 SUSTAIN participants entered the continuation phase. In the SWITCH group, HbA1c was significantly decreased by −1.4% (95% confidence interval [CI] −1.7% to −1.1%; P < 0.001) from a mean ± SD of 8.9% ± 0.8% (73.9 ± 8.6 mmol/mol) at 6 months to 7.5% ± 0.6% (58.5 ± 6.9 mmol/mol) at 12 months. Mean HbA1c increased by 0.1% (95% CI −0.05% to +0.25%), from 7.3% ± 0.6% (56.5 ± 6.7 mmol/mol) to 7.4% ± 0.8% (57.7 ± 9.1 mmol/mol) in the SUSTAIN group, meeting noninferiority criteria. Three severe hypoglycaemia events occurred in two SWITCH participants during the continuation phase. Conclusion: ADAPT study phase glycaemic improvements were reproduced and sustained in the continuation phase, supporting the early adoption of AID therapy in people with type 1 diabetes not meeting glucose targets on MDI therapy. [ABSTRACT FROM AUTHOR]

Objective: The use of parathyroid lesion aspiration in preoperative adenoma localisation is controversial. Concerns have been raised regarding both immediate safety (hematoma, infection, alterations on a subsequent histologic preparate) and long‐term safety (seeding). We aimed to evaluate the short‐ and long‐term safety, and the efficacy, of parathyroid fine‐needle aspiration with parathyroid hormone washout as a localisation modality of parathyroid adenoma in patients with primary hyperparathyroidism. Design: A retrospective study. Patients: The sample comprised 29 patients with primary hyperparathyroidism who underwent minimally invasive parathyroidectomy at a tertiary referral centre, following localisation with parathyroid hormone washout. Measurements: We reviewed all parathyroid hormone washout procedures performed during 2011–2021. Clinical, biochemical, and imaging information; and cytology, surgery, and pathology reports were extracted from electronic medical records. Results: Parathyroid hormone levels from the needle wash were 2.1–112.5 times the upper limit of the serum norm. Other than mild neck discomfort, no immediate procedure complications were documented. Fibrotic changes and necrosis were reported in two patients, with no effect on the final pathologic diagnosis or surgery course. No long‐term complications (seeding, or parathyromatosis) were found. A total of 26 (90%) patients who were operated following a positive parathyroid hormone washout result were normocalcemic at the end of a mean 38.1‐month follow‐up period. Conclusions: Parathyroid fine‐needle aspiration with parathyroid hormone washout was accurate. Immediate, surgical, or delayed complications were not demonstrated in our series. This approach might be considered for selected patients. [ABSTRACT FROM AUTHOR]

Aim: We studied real‐world performance of MiniMed (MM) 780G system users from Argentina, Brazil, Colombia and Chile (geographical analysis), and the effect of each technology iteration of the MM system on glycaemic control (technology iteration analysis). Materials and Methods: CareLink data from August 2020 to September 2022 were extracted. Endpoints included continuous glucose monitoring metrics. For the geographical analysis, aggregated endpoints for MM780G system users were calculated. For the technology iteration analysis, MM780G system user outcomes were compared with outcomes when the same individuals were still using the MM640G or MM670G system. Results: On average, 1025 MM780G system users from the geographical analysis were followed for 136 (SD 135) days, spent 91.5 (14.3)% in advanced hybrid closed loop, showed a glucose management indicator (GMI) of 6.7 (0.3)%, a time in range between 70 and 180 mg/dl (TIR) of 76.5 (9.0)%, and a time below range 70 mg/dl (TBR) of 2.7 (2.1)%. The percentage of users reaching targets of GMI <7%, TIR >70% and TBR <4% was 80.8%, 78.1% and 80.1%, respectively. The technology iteration analysis on users transitioning from MM640G to MM780G system (N = 381) showed 0.4% decrease in GMI (7.1% to 6.7%, p <.0001), 10.7% increase in TIR (65.9% to 76.6%, p <.0001), while TBR remained. The percentage of insulin delivered automatically increased as well (47.5%‐57.7%, p <.0001). Users transitioning from MM670G system (N = 78) showed a similar but less pronounced pattern. Conclusions: Real‐world Latin American MM780G users on average showed good glucose control, achieving international targets. Glycaemic control increased with every technology iteration of the MM system, providing more automation each time. [ABSTRACT FROM AUTHOR]