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Current insulin infusion sets are approved for only 2-3 days. The novel ConvaTec infusion set with Lantern technology is designed to extend infusion set wear time. The goal of this pilot study was to evaluate the duration of wear for this set. This was a pilot safety study in adults with type 1 diabetes using tethered insulin pumps. Participants inserted the set and wore it for 10 days or until failure. Among 24 participants, two were excluded. Forty-five per cent of the sets lasted 10 days. Median wear time was 9.1 (7.1, 10.0) days. Among 12 premature failures, six (50%) involved adhesive failures, four (33%) hyperglycaemia unresponsive to correction, one (8%) hyperglycaemia with ketones and one (8%) infection. Average CGM glucose per day of infusion set wear showed a statistically significant increase over time, while total daily insulin over the same period did not change. In this pilot study, the duration of wear for the novel infusion set exceeded previously reported commercial sets (P < .001). This extended wear technology may eventually allow for a combined glucose sensor and infusion set.

The Omnipod® 5 Automated Insulin Delivery System is a waterproof (IP28) hybrid closed-loop system where the continuous glucose monitor (CGM) communicates directly with the algorithm on the Pod to modulate insulin delivery automatically. However, the system relies on Bluetooth® wireless technology, a radiofrequency with limited underwater transmission ability. Seven frequent swimmers participating in the Omnipod 5 trial reported 63 separate swimming sessions ranging 25-143 min (mean 75±30 min) . CGM-to-Pod wireless communication during swims had a median (IQR) success rate of 17% (5%, 29%) ; however, the communication success rate was 100% across all swims with CGM-to-Pod distance These results suggest that while in-water communication is challenged, Pod to CGM placement strategies can be practiced to better improve the connectivity. Moreover, the system by design remains in automated mode when CGM values are missed and does not revert the user back to manual mode settings. Disclosure M.S.Hughes: Research Support; Insulet Corporation. R.S.Kingman: Research Support; Insulet Corporation. L.Hsu: Research Support; Insulet Corporation, Stock/Shareholder; Dexcom, Inc., Insulet Corporation, Tandem Diabetes Care, Inc. R.Lal: Advisory Panel; Provention Bio, Inc., Consultant; Abbott Diabetes, Biolinq, Capillary Biomedical, Inc., Deep Valley Labs, Gluroo, Morgan Stanley, Tidepool. B.A.Buckingham: Advisory Panel; Arecor, Lilly Diabetes, Medtronic, Other Relationship; Insulet Corporation, Research Support; Insulet Corporation, Lilly Diabetes, Medtronic. D.P.Zaharieva: Research Support; Insulet Corporation, International Society for Pediatric and Adolescent Diabetes, Leona M. and Harry B. Helmsley Charitable Trust. Funding Gift funding from Insulet Corporation

Background: The objective of this study was to assess the safety and performance of the Omnipod® personalized model predictive control (MPC) algorithm in adults, adolescents, and children aged ≥6 years with type 1 diabetes (T1D) under free-living conditions using an investigational device. Materials and Methods: A 96-h hybrid closed-loop (HCL) study was conducted in a supervised hotel/rental home setting following a 7-day outpatient standard therapy (ST) phase. Eligible participants were aged 6–65 years with A1C

OBJECTIVE Achieving optimal glycemic control for many individuals with type 1 diabetes (T1D) remains challenging, even with the advent of newer management tools, including continuous glucose monitoring (CGM). Modern management of T1D generates a wealth of data; however, use of these data to optimize glycemic control remains limited. We evaluated the impact of a CGM-based decision support system (DSS) in patients with T1D using multiple daily injections (MDI). RESEARCH DESIGN AND METHODS The studied DSS included real-time dosing advice and retrospective therapy optimization. Adults and adolescents (age >15 years) with T1D using MDI were enrolled at three sites in a 14-week randomized controlled trial of MDI + CGM + DSS versus MDI + CGM. All participants (N = 80) used degludec basal insulin and Dexcom G5 CGM. CGM-based and patient-reported outcomes were analyzed. Within the DSS group, ad hoc analysis further contrasted active versus nonactive DSS users. RESULTS No significant differences were detected between experimental and control groups (e.g., time in range [TIR] +3.3% with CGM vs. +4.4% with DSS). Participants in both groups reported lower HbA1c (−0.3%; P = 0.001) with respect to baseline. While TIR may have improved in both groups, it was statistically significant only for DSS; the same was apparent for time spent CONCLUSIONS Our DSS seems to be a feasible option for individuals using MDI, although the glycemic benefits associated with use need to be further investigated. System design, therapy requirements, and target population should be further refined prior to use in clinical care.

Background: This study assessed the efficacy and safety of ultrarapid insulin Fiasp(®) in the hybrid closed-loop MiniMed™ 670G system. Methods: This was a pilot randomized double-blinded crossover study among established MiniMed™ 670G users comparing percentage time in range (TIR) and hypoglycemia for Novolog(®) and Fiasp. After 2 weeks optimization with their home insulin, participants were randomized to receive Novolog or Fiasp for 2 weeks, followed by the other insulin for the next 2 weeks. Data from the second week of blinded insulin use were analyzed to allow 1 week for 670G adaptation. During the second week, individuals were asked to eat the same breakfast for 3 days to assess differences in meal pharmacodynamics. Results: Nineteen adults were recruited with mean age of 40 ± 18 years, diabetes duration of 27 ± 12 years, and median hemoglobin A1c of 7.1% (6.9, 7.5), using 0.72 (0.4, 1.2) units/(kg·day). For Novolog and Fiasp, respectively, the %TIR (70–180 mg/dL) was 75.3 ± 9.5 and 78.4 ± 9.3; %time 180 mg/dL was 21.6 ± 9.0 and 19.3 ± 8.9; mean glucose was 147 ± 12 and 146 ± 12 mg/dL; coefficient of variation was 28.6% ± 4.5% and 26.8% ± 4.4%; %time in auto mode 86.4 ± 9.2 and 84.4 ± 9.2. All comparisons were nonsignificant for insulin type. Total daily dose (Novolog 48.8 ± 28.4 vs. Fiasp 52.4 ± 31.7 units; P = 0.01) and daily basal (Novolog 17.6 [15.5, 33.8] vs. Fiasp 19.1 [15.3, 38.5] units; P = 0.07) correlated with TIR and %time >180 mg/dL. For insulin delivery in auto mode there was no statistical difference in total daily dose or daily basal between arms. Paired analysis for matched breakfast meals revealed no significant differences in time to maximum glucose, peak glucose, or glucose excursion. Conclusions: In this pilot study, the use of either Novolog or Fiasp in a commercially available MiniMed 670G system operating in auto mode resulted in clinically similar glycemic outcomes, with a slight increase in daily insulin requirements using Fiasp.

The Gen3 iLet (iLet) is a purpose-built, fully integrated, bionic pancreas (BP) platform that can operate in a bihormonal, insulin-only, or glucagon-only mode and can receive data from the Dexcom G5 or the Senseonics Eversense implanted CGM. We performed a random-order, cross-over, outpatient study comparing the insulin-only mode of the iLet to usual care (UC) for 7 days each as a bridge from past studies using the BP algorithm on an iPhone connected wirelessly to an insulin pump. The study enrolled adults with T1D who used either MDI (n=12) or CSII (n=22) for their UC. Participants enrolled at Massachusetts General Hospital (n=17) used the Eversense while those at Stanford (n=17) used the G5 as the input CGM signal for the iLet. There was no statistically significant difference between the iLet and UC in % time Disclosure R.Z. Jafri: None. C.A. Balliro: None. J. Sherwood: None. M. Hillard: None. L. Ekhlaspour: None. L. Hsu: None. R. Selagamsetty: Employee; Self; Beta Bionics. Other Relationship; Self; Boston University. J.R. Costik: Board Member; Self; Nightscout Foundation. Employee; Self; Beta Bionics. Employee; Spouse/Partner; Ortho Clinical Diagnostics. J. Sloane: None. B.A. Buckingham: Advisory Panel; Self; ConvaTec Inc., Novo Nordisk Inc., Profusa, Inc. Consultant; Self; Medtronic MiniMed, Inc. Research Support; Self; Beta Bionics, ConvaTec Inc., Dexcom, Inc., Insulet Corporation, Medtronic MiniMed, Inc., Tandem Diabetes Care. Other Relationship; Self; Insulet Corporation, Tandem Diabetes Care. F. El-Khatib: Employee; Self; Beta Bionics. Stock/Shareholder; Self; Beta Bionics. E. Damiano: Advisory Panel; Self; Novo Nordisk A/S. Board Member; Self; Beta Bionics. Employee; Self; Beta Bionics. Stock/Shareholder; Self; Beta Bionics. Stock/Shareholder; Spouse/Partner; Beta Bionics. Other Relationship; Self; Ascensia Diabetes Care, Senseonics. S.J. Russell: Advisory Panel; Self; Companion Medical, Unomedical a/s. Consultant; Self; Flexion Therapeutics. Research Support; Self; Beta Bionics, MITRE Corporation, Novo Nordisk A/S, Zealand Pharma A/S. Other Relationship; Self; ADOCIA, Ascensia Diabetes Care, Ascensia Diabetes Care, Lilly Diabetes, Roche Diabetes Care, Senseonics. Funding National Institute of Diabetes and Digestive and Kidney Diseases (UC4DK108612)

Objective: Current insulin infusion sets are approved for 2-3 days of wear; however, glucose sensors are approved for 7-14 days of wear. A commonly reported reason for discontinuing use of CGM within 1 year is not wanting to wear devices on two sites of the body. Any attempt to create a combined glucose sensor and infusion set for closed-loop control requires a set with greater longevity. The coated ConvaTec Infusion Set with Lantern Technology is a new infusion set with multiple slits and coating intended to reduce foreign body response and occlusion from bending or kinking. Methods: A pilot safety and extended wear tolerability study is being performed at Stanford University. To date, 15 adult subjects on tethered insulin pump therapy using insulin aspart or lispro have completed the study. Each participant places the set and wears it for 10 days or until set failure to establish a maximum length of infusion set wear when 80% of sets are still functional (excluding accidental “pull-outs”). Infusion set failures are based on: (1) Presence of serum ketones with hyperglycemia; (2) Unexplained hyperglycemia, unresolved with correction dose; (3) Signs of infection at the infusion site; (4) Pump occlusion alarm; and (5) Adhesive failure. Results: Two subjects did not meet failure criteria and were excluded. Of the remaining, 6 (46%) wore the novel infusion set the full 10 days and all sets lasted 7 days or more (mean 8.8 days). 3 premature set failures were associated with persistent hyperglycemia unresponsive to correction boluses on days 7-8, 3 with adhesive failure on days 7-9, and 1 with infection on day 9. Conclusions: In our previous studies assessing 353 infusion set insertions for 7 days, average length of wear was 5.1 ± 1.7 days. Thus far, the novel set has demonstrated increased longevity. The duration of wear established in this pilot study will be used to perform a masked, randomized controlled crossover study comparing the coated ConvaTec Infusion Set with Lantern Technology against standard infusion sets. Disclosure R. Lal: Consultant; Self; Abbott. P.K. Schøndorff: Employee; Self; ConvaTec Inc. L. Hsu: None. M. Heschel: Employee; Self; Unomedical a/s. B.A. Buckingham: Advisory Panel; Self; ConvaTec Inc., Novo Nordisk Inc., Profusa, Inc. Consultant; Self; Medtronic MiniMed, Inc. Research Support; Self; Beta Bionics, ConvaTec Inc., Dexcom, Inc., Insulet Corporation, Medtronic MiniMed, Inc., Tandem Diabetes Care. Other Relationship; Self; Insulet Corporation, Tandem Diabetes Care.

In a random-order, outpatient crossover trial we compared automated glycemic control with the insulin-only bionic pancreas (BP) to usual care in subjects with T1D. Subjects transitioned directly to the BP from CSII or MDI (insulins glargine n=6, detemir n=1, or degludec n=5). The BP continuously adapts to individual insulin needs and was initialized based on body mass only, without information about the baseline insulin regimen. The first 24 hours of BP control was compared to days 3-7 (the 5-day period considered for the primary outcome) to examine the effect of having received long-acting insulin the day prior to initiation of the BP. As shown in the Table, the mean CGM glucose and time-in-range did not differ between the first 24 hours and days 3-7 after starting the BP in subjects on MDI at baseline, while there was a reduction in mean and an increase in time-in-range among those on CSII at baseline. Subjects on MDI at baseline did not experience more hypoglycemia in the first 24 hours despite having long-acting insulin on board. Both subjects on MDI and CSII at baseline achieved good glucose control on the BP (see Table). Surprisingly, there was no difference in the insulin total daily dose (TDD) between the first 24 hours and days 3-7 in the MDI users despite an average TDD of basal insulin at baseline of 15 u/day. These results suggest that BP therapy can be safely initiated directly from MDI regimens. Disclosure J. Sherwood: None. C.A. Balliro: None. F. El-Khatib: Employee; Self; Beta Bionics. Stock/Shareholder; Self; Beta Bionics. L. Ekhlaspour: None. L. Hsu: None. B.A. Buckingham: Advisory Panel; Self; ConvaTec Inc., Novo Nordisk Inc., Profusa, Inc. Consultant; Self; Medtronic MiniMed, Inc. Research Support; Self; Beta Bionics, ConvaTec Inc., Dexcom, Inc., Insulet Corporation, Medtronic MiniMed, Inc., Tandem Diabetes Care. Other Relationship; Self; Insulet Corporation, Tandem Diabetes Care. E. Damiano: Advisory Panel; Self; Novo Nordisk A/S. Board Member; Self; Beta Bionics. Employee; Self; Beta Bionics. Stock/Shareholder; Self; Beta Bionics. Stock/Shareholder; Spouse/Partner; Beta Bionics. Other Relationship; Self; Ascensia Diabetes Care, Senseonics. S.J. Russell: Advisory Panel; Self; Companion Medical, Unomedical a/s. Consultant; Self; Flexion Therapeutics. Research Support; Self; Beta Bionics, MITRE Corporation, Novo Nordisk A/S, Zealand Pharma A/S. Other Relationship; Self; ADOCIA, Ascensia Diabetes Care, Ascensia Diabetes Care, Lilly Diabetes, Roche Diabetes Care, Senseonics. Funding National Institutes of Health (NIDDKUC4DK108612)

The Gen3 iLet (iLet) is a physically and functionally integrated, bionic pancreas (BP) platform that can operate in bihormonal, insulin-only, or glucagon-only modes. The iLet in insulin-only mode has never been tested in subjects Twenty youth (mean age=12±3 [range 7-17] years) completed a 10-day, randomized crossover study at 3 sites comparing 5 days using the insulin-only iLet to 5 days of usual care (UC) with sensor-augmented pump therapy. During the day, youth were supervised by study staff in a day-camp setting with periods of vigorous physical activity. At night, participants returned home with their guardians, and staff monitored glucose levels remotely. Participants achieved good glycemic control with low levels of hypoglycemia in both the UC and iLet arms (see Table). There were 3 hyperglycemic events associated with iLet malfunction, including one failure of insulin delivery with alarms not heard and two instances of insulin cartridges leaking. These events and others observed by the study teams, guardians, and participants led to changes in the Gen4 iLet under development to improve safety and usability. These results suggest that testing of the improved Gen4 iLet is warranted and offers promise in the pediatric population. Disclosure L. Ekhlaspour: None. G.P. Forlenza: Advisory Panel; Self; Dexcom, Inc. Consultant; Self; Medtronic MiniMed, Inc., Tandem Diabetes Care. Research Support; Self; Dexcom, Inc., Insulet Corporation, Medtronic MiniMed, Inc., Tandem Diabetes Care. C. Berget: Consultant; Self; Insulet Corporation, Medtronic. K.R. Bird: None. K.A. Englert: Consultant; Self; PicoLife Technologies, LLC. L. Hsu: None. C.A. Balliro: None. N. Mauras: Consultant; Self; Novo Nordisk Inc., PicoLife. Research Support; Self; Medtronic MiniMed, Inc. R. Wadwa: Advisory Panel; Self; Eli Lilly and Company. Research Support; Self; Beta Bionics, MannKind Corporation, Novo Nordisk Inc., Tandem Diabetes Care, Xeris Pharmaceuticals, Inc. Other Relationship; Self; Dexcom, Inc. B.A. Buckingham: Advisory Panel; Self; ConvaTec Inc., Novo Nordisk Inc., Profusa, Inc. Consultant; Self; Medtronic MiniMed, Inc. Research Support; Self; Beta Bionics, ConvaTec Inc., Dexcom, Inc., Insulet Corporation, Medtronic MiniMed, Inc., Tandem Diabetes Care. Other Relationship; Self; Insulet Corporation, Tandem Diabetes Care. F. El-Khatib: Employee; Self; Beta Bionics. Stock/Shareholder; Self; Beta Bionics. E. Damiano: Advisory Panel; Self; Novo Nordisk A/S. Board Member; Self; Beta Bionics. Employee; Self; Beta Bionics. Stock/Shareholder; Self; Beta Bionics. Stock/Shareholder; Spouse/Partner; Beta Bionics. Other Relationship; Self; Ascensia Diabetes Care, Senseonics. S.J. Russell: Advisory Panel; Self; Companion Medical, Unomedical a/s. Consultant; Self; Flexion Therapeutics. Research Support; Self; Beta Bionics, MITRE Corporation, Novo Nordisk A/S, Zealand Pharma A/S. Other Relationship; Self; ADOCIA, Ascensia Diabetes Care, Ascensia Diabetes Care, Lilly Diabetes, Roche Diabetes Care, Senseonics. Funding National Institute of Diabetes and Digestive and Kidney Diseases (1UC4DK108612)

Background: Using sensor augmented pump data, late or missed meal boluses have shown a strong correlation with higher A1c levels, particularly in adolescents. With the Type Zero InControl Phone connected to a Dexcom G5 sensor and Novo insulin pens with memory and connectivity it is now possible to evaluate for late and missed meal boluses in MDI users. Methods: For this study 326 days of CGM data were evaluated from 24 subjects (mean age 33, range 15-59 years). Seven days of data were analyzed on starting the system and 7 days 1 month later. Overall 1,173 meals were evaluated. Meals were determined by either the subject manually recording the meal, or if the CGM was >70 mg/dl and there was a >70 mg/dl rise within 2 hours. A late meal bolus was defined when the CGM increased >50 mg/dl from baseline prior to an insulin dose. A missed meal bolus was defined by no insulin dose within 2 hours from the start of the CGM rise. Results: 27% (range 8 to 55%) of meals had either a late or missed meal boluses: 13% (range 2-30%) were late and 14% (range 2 to 38%) were missed. There was no correlation with age or gender. There was a positive correlation with the percentage of missed meal boluses and A1c levels (p=0.019), but no correlation with the percentage of late meal boluses and A1c levels. There were no significant differences in missed or late meal boluses when comparing the first week of use to using the system one month later. Conclusion: The rate of late or missed meal boluses is high for both adults and adolescents using MDI therapy, and missed meal boluses correlated with higher A1c levels. Having this information may provide significant insight to patients and help clinicians provide advice to MDI patients. Disclosure L.M. Norlander: None. S. Anderson: Research Support; Self; Medtronic. Consultant; Self; Senseonics. C.J. Levy: Advisory Panel; Self; Medtronic MiniMed, Inc.. Research Support; Self; Lexicon Pharmaceuticals, Inc., Dexcom, Inc.. L. Ekhlaspour: None. D.W. Lam: None. L. Hsu: None. S.E. Loebner: None. S.J. Ogyaadu: None. G. O'Malley: None. C.M. Levister: None. M.D. Breton: Stock/Shareholder; Self; TypeZero Technologies, Inc.. Speaker's Bureau; Self; Ascensia Diabetes Care. Consultant; Self; Sanofi. Speaker's Bureau; Self; Roche Diabetes Care Health and Digital Solutions. Research Support; Self; Dexcom, Inc., Ascensia Diabetes Care, Senseonics. B. Buckingham: Advisory Panel; Self; Novo Nordisk Inc., ConvaTec Inc.. Research Support; Self; Medtronic, Insulet Corporation, Dexcom, Inc., Tandem Diabetes Care, Inc.. Consultant; Self; Tandem Diabetes Care, Inc., Becton, Dickinson and Company.

Priming insulin pens is recommended to remove air from needles to ensure full dose administration. Little is known regarding how often or how much patients prime during home use or its relation to glucose control. We evaluated patterns of pen priming in patients with type 1 diabetes using NovoPens for insulin administration. Patients were trained on use of pens including how and why to prime for doses. Two sites taught a 2 unit prime, site 3 until insulin seen. Pens were synced to a study phone via a near field communicator and marked as prime or injection. Records were assessed for prime frequency and amount. For this interim analysis, 16,135 pen records from 25 patients were analyzed. The percent of injections with a prime was 80% overall but ranged from 2-99%. Prime amount varied and did not correlate to HbA1C. For patients who primed until insulin seen, 74% of the primes did not necessitate 2 or more units. Prime frequency was defined as low if 75%. The frequencies were not evenly distributed; instead patients would prime the majority of the time or infrequently. Percentage of missed prime did not correlate with HbA1C, but seemed to correlate with male gender and younger age. Missed prime of insulin pens is fairly common, but the frequency is variable. Insulin pens which track doses offer important data regarding appropriate use. This information provides insight for education and treatment.GenderHbA1c at enrollmentAge (yrs)Diabetes duration (yrs)No prime (%injections)75%)6 men 13 women7.6%36206%29%65%Overall12 men 13 women7.5% (range 5.3-9.3%)33 (range 17-57)17 (range 2-44)Overall: 20%. Sites teaching 2 units: 19%. Site teaching until insulin seen: 21%.Overall: 25%. Sites teaching 2 units: 7%. Site teaching until insulin seen: 62%.Overall: 55%. Sites teaching 2 units: 74%. Site teaching until insulin seen: 17%. Disclosure G. O'Malley: None. S.J. Ogyaadu: None. D.W. Lam: None. L.M. Norlander: None. J. Robic: None. C.M. Levister: None. S. Anderson: Research Support; Self; Medtronic. Consultant; Self; Senseonics. L. Hsu: None. S.E. Loebner: None. L. Ekhlaspour: None. M.D. Breton: Stock/Shareholder; Self; TypeZero Technologies, Inc.. Speaker's Bureau; Self; Ascensia Diabetes Care. Consultant; Self; Sanofi. Speaker's Bureau; Self; Roche Diabetes Care Health and Digital Solutions. Research Support; Self; Dexcom, Inc., Ascensia Diabetes Care, Senseonics. B.A. Buckingham: Advisory Panel; Self; Novo Nordisk Inc., ConvaTec Inc.. Research Support; Self; Medtronic, Insulet Corporation, Dexcom, Inc., Tandem Diabetes Care, Inc.. Consultant; Self; Tandem Diabetes Care, Inc., Becton, Dickinson and Company. C.J. Levy: Advisory Panel; Self; Medtronic MiniMed, Inc.. Research Support; Self; Lexicon Pharmaceuticals, Inc., Dexcom, Inc..