Background: Typically, closed-loop control (CLC) studies excluded patients with significant hypoglycemia. We evaluated the effectiveness of hybrid CLC (HCLC) versus sensor-augmented pump (SAP) in reducing hypoglycemia in this high-risk population. Methods: Forty-four subjects with type 1 diabetes, 25 women, 37-2 years old, HbA1c 7.4%-0.2% (57-1.5 mmol/mol), diabetes duration 19-2 years, on insulin pump, were enrolled at the University of Virginia (N = 33) and Stanford University (N = 11). Eligibility: increased risk of hypoglycemia confirmed by 1 week of blinded continuous glucose monitor (CGM); randomized to 4 weeks of home use of either HCLC or SAP. Primary/secondary outcomes: risk for hypoglycemia measured by the low blood glucose index (LBGI)/ CGM-based time in ranges. Results: Values reported: meanstandard deviation. From baseline to the final week of study: LBGI decreased more on HCLC (2.51-1.17 to 1.28-0.5) than on SAP (2.1-1.05 to 1.79-0.98), P < 0.001; percent time below 70 mg/dL (3.9 mmol/L) decreased on HCLC (7.2%-5.3% to 2.0%-1.4%) but not on SAP (5.8%-4.7% to 4.8%-4.5%), P = 0.001; percent time within the target range 70-180 mg/dL (3.9-10 mmol/L) increased on HCLC (67.8%-13.5% to 78.2%-10%) but decreased on SAP (65.6%-12.9% to 59.6%-16.5%), P < 0.001; percent time above 180 mg/dL (10 mmol/L) decreased on HCLC (25.1%-15.3% to 19.8%-10.1%) but increased on SAP (28.6%-14.6% to 35.6%-17.6%), P = 0.009. Mean glucose did not change significantly on HCLC (144.

Assess the efficacy of inControl AP, a mobile closed-loop control (CLC) system. RESEARCH DESIGN AND METHODSThis protocol, NCT02985866, is a 3-month parallel-group, multicenter, randomized unblinded trial designed to compare mobile CLC with sensor-augmented pump (SAP) therapy. Eligibility criteria were type 1 diabetes for at least 1 year, use of insulin pumps for at least 6 months, age ‡14 years, and baseline HbA 1c <10.5% (91 mmol/mol). The study was designed to assess two coprimary outcomes: superiority of CLC over SAP in continuous glucose monitor (CGM)-measured time below 3.9 mmol/L and noninferiority in CGM-measured time above 10 mmol/L. RESULTSBetween November 2017 and May 2018, 127 participants were randomly assigned 1:1 to CLC (n 5 65) versus SAP (n 5 62); 125 participants completed the study. CGM time below 3.9 mmol/L was 5.0% at baseline and 2.4% during follow-up in the CLC group vs. 4.7% and 4.0%, respectively, in the SAP group (mean difference 21.7% [95% CI 22.4, 21.0]; P < 0.0001 for superiority). CGM time above 10 mmol/L was 40% at baseline and 34% during follow-up in the CLC group vs. 43% and 39%, respectively, in the SAP group (mean difference 23.0% [95% CI 26.1, 0.1]; P < 0.0001 for noninferiority). One severe hypoglycemic event occurred in the CLC group, which was unrelated to the study device. CONCLUSIONSIn meeting its coprimary end points, superiority of CLC over SAP in CGM-measured time below 3.9 mmol/L and noninferiority in CGM-measured time above 10 mmol/L, the study has demonstrated that mobile CLC is feasible and could offer certain usability advantages over embedded systems, provided the connectivity between system components is stable.People with type 1 diabetes face a life-long optimization problem: limiting their exposure to hyperglycemia while simultaneously avoiding hypoglycemia (1). Classic studies have shown that many complications from diabetes are predicted by average glycemia, typically assessed by hemoglobin A 1c (HbA 1c ), and can be reduced with intensive insulin therapy (2,3); however, the risk for hypoglycemia remains the primary barrier to optimal glycemic control (1). At present, closed-loop control (CLC), known as the artificial pancreas, offers the best solution to this optimization problem: day-and-night real-time fine-tuning of insulin delivery by an automated system.In the past few years, the volume of CLC clinical trials increased dramatically. In 2018, the National Library of Medicine included 132 publications in the CLC field, and in the first 6 weeks of 2019 alone, 25 new articles were published. Research results are

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 &gt;70 mg/dl and there was a &gt;70 mg/dl rise within 2 hours. A late meal bolus was defined when the CGM increased &gt;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.

This article offers clinicians resources and an overview for supporting gender-diverse individuals with diabetes. Creating a supportive office environment is crucial to providing optimal diabetes care for patients who identify as transgender.

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 &lt;25%, variable if 25-75% or consistent if &gt;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)&lt;2 units primes (%injections)≥2 units primes (%injections)Low primers (&lt;25%)3 men7.9%23990%5%5%Variable (25-75%)3 men6.4%241035%22%43%Consistent (&gt;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..