Introduction and Objective: A gestational diabetes (GDM) diagnosis is unexpected and brings immediate need for diabetes self-management. This multicenter observational study examined the impact of CGM on individual’s experiences with GDM management. Methods: People diagnosed with GDM were enrolled at 3 sites, a standardized patient education sheet was reviewed and provided and participants were asked to use Dexcom G7 CGM for glucose monitoring for the remainder of pregnancy. GDM was managed by their obstetric clinicians. Outcomes included CGM metrics and satisfaction surveys administered postpartum. Results: 50 individuals (A1 no medication n=18, A2 medication use n=32) were enrolled: BMI 31.0 (IQR 23.3, 36.8), 31 (62%) White, 41 (84%) CGM naive. CGM was worn 93% of days. Significant differences were seen in nocturnal CGM metrics between groups (Table). Satisfaction was high: 88% preferred CGM over SMBG with themes that CGM improved quality of life and provided new information about diabetes. Challenges for some participants included worry about glucose levels, sleep disruption, alarm fatigue and data issues. Conclusion: Individuals with GDM consistently used CGM with results suggesting CGM may improve self-management, quality of life during pregnancy and provide opportunities to optimize therapy for those using medication. Certain themes emerged where pregnant people may benefit from more education regarding CGM to improve their experience and health optimization. Disclosure A.M. Valent: Research Support; Current; Dexcom, Inc. Advisory Panel; Current; MannKind Corporation. Research Support; Current; MannKind Corporation. K. Castorino: Research Support; Current; Abbott, Abbott Diabetes. Research Support; Ended; Altimmune. Research Support; Current; Dexcom, Inc. Speaker's Bureau; Current; Dexcom, Inc. Research Support; Current; Eli Lilly and Company. Advisory Panel; Current; MannKind Corporation. Speaker's Bureau; Current; Insulet Corporation. Consultant; Ended; Sequel Med Tech. J. Layne: Employee; Current; Dexcom, Inc. Y. Xu: Employee; Current; Dexcom, Inc. D. Zabala: Employee; Current; Dexcom, Inc. B. Carrillo: Employee; Current; Dexcom, Inc. Stock/Shareholder; Current; Dexcom, Inc. C. Durnwald: Research Support; Current; Abbott Diabetes. Advisory Panel; Current; Abbott Diabetes. Research Support; Current; Dexcom, Inc., MannKind Corporation.

INTRODUCTION:The present study assessed the impact of the disposable Simplera Sync™ sensor with the MiniMed™ 780G (MM780G) advanced hybrid closed-loop (AHCL) system on type 1 diabetes (T1D) glycemic metrics, insulin delivery, and safety. MATERIALS AND METHODS:Youths (aged 7-17 years) and adults (aged 18-80 years) with T1D were enrolled in this single-arm, nonrandomized study at 24 sites in the United States. Participants began with an ∼2-week run-in period where hybrid closed-loop (HCL; auto basal only) or open-loop insulin delivery was used, followed by an ∼3-month study period with AHCL activated. Glycemic outcomes and insulin delivery during the last 6-7 weeks of the study, when settings were optimized at investigator's discretion, were compared with the run-in. Glycemic outcomes with the use of recommended optimal settings (ROS, 100 mg/dL glucose target with a 2-h active insulin time) were explored. RESULTS:Time in automation was high (>93%) and mean time in range (TIR) increased from 54.4% ± 15.7% to 71.4% ± 9.9% (P < 0.001) in youths and from 66.5% ± 12.6% to 80.2% ± 8.1% (P < 0.001) in adults, primarily due to reduced time above range. Youths had a slight increase in time below range (TBR <70 mg/dL) from 1.6% ± 1.7% to 1.9% ± 1.4% (P < 0.001), while adults had no significant difference in TBR. For ROS users, TIR was 74.7% ± 9.3% in youths and 83.8% ± 7.4% in adults. Throughout the study ∼60% of total daily insulin dose was automated (auto basal and auto correction) in both cohorts. There were two cases of severe hypoglycemia and one episode of diabetic ketoacidosis (not related to the device). CONCLUSIONS:MM780G use with the Simplera Sync sensor is safe and demonstrated improved glycemic outcomes in both pediatric and adult participants with T1D, compared with the run-in period.

Introduction and Objective: A recent randomized crossover trial compared a next-generation algorithm for Omnipod (Omnipod 6) with the first-generation Omnipod® 5 Automated Insulin Delivery System in a diverse population including adults (T1D/T2D) and children (T1D). This subgroup analysis assessed safety and efficacy within the vulnerable population of children with T1D who face elevated hypoglycemia risk. Methods: This multicenter, randomized, crossover study compared Omnipod 6 at a 100 mg/dL target with Omnipod 5 at a 110mg/dL target (4 weeks each) in current Omnipod 5 users. Safety and efficacy outcomes were evaluated in children ages 2-<6 and 6-<14y. Results: Children aged 2-<6y (n=29; age: 4.1±0.9y, baseline A1C: 7.0±0.8%) and 6-<14y (n=36; age: 10.7±2.2y, baseline A1C: 7.0±0.8%) with T1D were randomly assigned. The 100mg/dL target was used 82% and 95% of time in the 2-<6y and 6-<14y groups, respectively, with Omnipod 6. Time in tight range (70-140mg/dL) increased by 5.5% (+1.3h/d) with Omnipod 6 in those aged 6-<14y with no change in those aged 2-<6y (Table). Time <54 and <70mg/dL remained low in both groups, meeting the non-inferiority margins of 0.75% and 3%, respectively. No severe hypoglycemia or DKA events occurred. Conclusion: These results demonstrate safety and strong efficacy potential of the next-generation Omnipod 6 algorithm in children with T1D as young as 2y. Disclosure D.J. DeSalvo: Consultant; Current; Dexcom, Inc., Insulet Corporation. Advisory Panel; Current; Sanofi. Research Support; Current; Medtronic. G. Forlenza: Other - Research Support, Speaker, Ad Board Member; Current; Medtronic. Other - Research Support, Speaker, Consultant; Current; Dexcom, Inc. Research Support; Current; Abbott. Other - Research Support, Speaker, Consultant; Current; Insulet Corporation, Tandem Diabetes Care, Inc. Research Support; Current; MannKind Corporation. Other - Research Support, Consultant; Current; Sequel. L.M. Laffel: Other - Travel support for scientific presentations; Ended; Boehringer Ingelheim International GmbH. Other - DSMB Chair; Ended; Janssen Pharmaceuticals, Inc. Consultant; Current; Dexcom, Inc. Advisory Panel; Current; Medtronic, Sequel, Tandem Diabetes Care, Inc. Consultant; Current; Roche Diabetes Care, Sinocare. Advisory Panel; Ended; Sanofi. Advisory Panel; Current; MannKind Corporation. A. Criego: Other - I am contracted for my time through my employer HealthPartners Institute dba International Diabetes Center with no direct financial compensation to me personally.; Current; Abbott Diabetes. Other - Research, Advisory Board and Speakers Bureau involvement is contracted for my time through my employer HealthPartners Institute dba International Diabetes Center with no direct financial compensation to me personally.; Current; Insulet Corporation. Other - Research involvement is contracted for my time through my employer HealthPartners Institute dba International Diabetes Center with no direct financial compensation to me personally.; Current; Medtronic. Other - I am contracted for my time through my employer HealthPartners Institute dba International Diabetes Center with no direct financial compensation to me personally.; Current; Medscape, Dexcom, Inc. K. Castorino: Research Support; Current; Abbott, Abbott Diabetes. Research Support; Ended; Altimmune. Research Support; Current; Dexcom, Inc. Speaker's Bureau; Current; Dexcom, Inc. Research Support; Current; Eli Lilly and Company. Advisory Panel; Current; MannKind Corporation. Speaker's Bureau; Current; Insulet Corporation. Consultant; Ended; Sequel Med Tech. S. MacLeish: Speaker's Bureau; Current; Insulet Corporation. Research Support; Current; Insulet Corporation, Dexcom, Inc., Medtronic. D. Raghinaru: None. R.W. Beck: Research Support; Current; MannKind Corporation, Abbott Diabetes, Dexcom, Inc., Tandem Diabetes Care, Inc., Sequel Med Tech, DreaMed Diabetes, Ltd. Consultant; Ended; Novo Nordisk, Eli Lilly and Company. Consultant; Current; Zucara Therapeutics. T.T. Ly: Employee; Current; Insulet Corporation. Stock/Shareholder; Current; Insulet Corporation. J. Sherr: Other - research support, consultant, advisory board member; Current; Abbott Diabetes. Other - advisory board member, consultant; Current; Vertex Pharmaceuticals Incorporated. Consultant; Current; Ypsomed AG. Research Support; Current; Dexcom, Inc., JDRF, Provention Bio, Inc., National Institutes of Health. Other - research support, consultant, advisory board member; Current; Insulet Corporation, Medtronic. Research Support; Current; Sanofi. Advisory Panel; Current; sequel med tech. Funding This study was funded by Insulet Corporation.

AIMS:Beyond their glycaemic benefits, automated insulin delivery (AID) systems can provide psychosocial benefits for people with type 1 diabetes (T1D) and improve quality of life. In this study, we evaluated psychosocial outcomes in adults with T1D using the tubeless Omnipod® 5 AID System compared with sensor augmented pump (SAP) therapy. MATERIALS AND METHODS:As part of a 13-week multicentre, parallel-group, randomised controlled trial comparing intervention (tubeless AID) and control (SAP) groups (2:1), adults aged 18-70 years with T1D completed validated psychosocial questionnaires assessing health-related quality of life (European Quality of Life 5 Dimensions 3 Level Version [EQ-5D-3L] index score and visual analogue scale [VAS]), the impact of diabetes on quality of life (DAWN2 Impact of Diabetes Profile [DIDP]), sleep quality (Pittsburgh Sleep Quality Index [PSQI]), system usability (System Usability Scale [SUS]) and perceptions before and experiences after using AID systems (INsulin Dosing Systems: Perceptions, Ideas, Reflections and Expectations [INSPIRE]). RESULTS:The intervention group saw greater score improvements than the control group for all measures evaluated, including health-related quality of life (EQ-5D-3L VAS, p = 0.01; EQ-5D-3L index score, p = 0.002), impact of diabetes on quality of life (DIDP, p = 0.004), perceived system usability (SUS, p < 0.0001) and sleep quality (PSQI, p = 0.03). INSPIRE scores, determined only for the intervention group, were high at baseline and follow-up, suggesting positive perceptions of tubeless AID. CONCLUSIONS:This randomised controlled trial demonstrated that the use of a tubeless AID system improved psychosocial measures to a greater extent than SAP therapy. These results contribute to the growing body of evidence demonstrating that AID may improve quality of life and alleviate some of the burden associated with diabetes self-management in adults with T1D.

Introduction and Objective: Postprandial (PP) hyperglycemia in pregnancy is a strong correlate for fetal overgrowth and adverse outcomes. The equivalence, efficacy, and safety of TI (Afrezza; inhaled human Regular insulin) in lowering PP hyperglycemia compared to RAA (lispro or aspart) have not been previously studied during pregnancy. We directly compared the glucose excursion and frequency of hypoglycemia (<63 mg/dL [3.5 mmol/L]) during two controlled breakfast visits utilizing TI versus RAA in GDM pregnancies. Methods: Consented pregnant participants with a diagnosis of GDM wearing at least one CGM, were randomized to complete two identical breakfast meal (~45 grams carbohydrate) sessions using either RAA or TI equivalent dosing (~2 times RAA dose) within a 10-day gestational window. Glucometer measures were performed every 15-30 mins for at least 3 hrs. This analysis compares the glucose metrics between the two treatments in the first 10 participants. Results: Mean maternal age was 33±6 yrs, 50% reported Hispanic or Latinx ethnicity, pre-pregnancy BMI was 35±6 kg/m2, and gestational age at screening was 29±4 weeks. There was a trend towards an overall lower glucose excursion (-2.8 mg/dL) and lower area under the curve >120 mg/dL [6.7 mmol/L] by -2.7 mg/dL and >140 mg/dL [7.8 mmol/L] by -1.3 mg/dL using TI vs RAA for the breakfast meal. The 1h- and 2h-PP blood glucose were 121±16 & 108±20 mg/dL for the TI and 129±25 & 107±25 mg/dL for the RAA meal. None of the TI meal sessions were complicated by hypoglycemia, whereas 3 of the RAA sessions were complicated by hypoglycemia following the meal. Conclusion: In this interim analysis of the first crossover RCT in GDM directly comparing PP glucose responses between TI vs RAA with a fixed breakfast meal, comparable effectiveness was demonstrated with a trend toward reduced glucose excursions and fewer hypoglycemic events with TI. Further investigation of a larger sample will further support safety and efficacy of TI as an alternative to RAA in GDM. Disclosure A. Valent: Research Support; Current; Dexcom, Inc. Advisory Panel; Current; MannKind Corporation. Research Support; Current; MannKind Corporation. R.W. Beck: Research Support; Current; MannKind Corporation, Abbott Diabetes, Dexcom, Inc., Tandem Diabetes Care, Inc., Sequel Med Tech, DreaMed Diabetes, Ltd. Consultant; Ended; Novo Nordisk, Eli Lilly and Company. Consultant; Current; Zucara Therapeutics. C. Durnwald: Research Support; Current; Abbott Diabetes. Advisory Panel; Current; Abbott Diabetes. Research Support; Current; Dexcom, Inc., MannKind Corporation. C. Levy: Research Support; Current; Tandem Diabetes Care, Inc., Novo Nordisk, Abbott Diabetes, MannKind Corporation. Consultant; Current; MannKind Corporation, Tandem Diabetes Care, Inc. Research Support; Current; Deka/Sequel, Dexcom, Inc., Genti Bio. Consultant; Current; Deka/Sequel. K. Castorino: Research Support; Current; Abbott, Abbott Diabetes. Research Support; Ended; Altimmune. Research Support; Current; Dexcom, Inc. Speaker's Bureau; Current; Dexcom, Inc. Research Support; Current; Eli Lilly and Company. Advisory Panel; Current; MannKind Corporation. Speaker's Bureau; Current; Insulet Corporation. Consultant; Ended; Sequel Med Tech. G. O'Malley: Research Support; Ended; Dexcom, Inc. Research Support; Current; Abbott, MannKind Corporation. I. Hirsch: Research Support; Current; MannKind Corporation, Sequel Tech. Consultant; Current; Abbott Diabetes, Roche Diabetes Care, Hagar. D.Y. Gyalnub: None. A. Bradbury: None. C.M. Levister: Research Support; Ended; Capillary Biomedical, Inc., Tandem Diabetes Care, Inc. Research Support; Current; DEKA, Sequel. J.E. Phipers: Research Support; Current; Pfizer Inc., Myriad Genetics, Jaeb Center for Health Research, National Heart, Lung, and Blood Institute. C. Ingram: None. K.C. Ruedy: None. L. Kanapka: None. L. Barbour: None. Funding Mannkind Jaeb

Introduction and Objective: A next-generation hybrid closed-loop algorithm for Omnipod was developed with the aim of improving outcomes while reducing burden for people with diabetes. This study evaluated the next-generation Omnipod 6 algorithm compared with the first-generation Omnipod® 5 Automated Insulin Delivery System in a diverse population of adults (T1D/T2D) and children (T1D). Methods: This multicenter, randomized, crossover study compared Omnipod 6 at a target of 100 mg/dL with Omnipod 5 at a target of 110 mg/dL (4 weeks each) in current Omnipod 5 users with T1D (2-70y) or T2D (18-70y). Primary safety endpoints were non-inferiority for percentage of time <54mg/dL, <70mg/dL, 70-180mg/dL, and mean glucose (margins: 0.75%, 3%, 3%, and 8mg/dL, respectively) tested hierarchically, with exploratory efficacy outcomes. Results: A total of 132 people (T1D: 74%; ages 2-<18y: 54%; baseline A1C: 7.0±0.8%) were randomly assigned to Omnipod 5 or 6. All safety endpoints were met. Exploratory testing showed superiority for all efficacy endpoints, including a 5.2% (+1.2h/d) increase in time in tight range (70-140mg/dL) with Omnipod 6 (Table). No severe hypoglycemia or DKA/HHS events occurred. Conclusion: The next-generation Omnipod 6 algorithm met the pre-specified safety outcomes. Exploratory outcomes highlight strong efficacy potential, with a clinically meaningful increase in time in tight range. Disclosure G. Forlenza: Other - Research Support, Speaker, Ad Board Member; Current; Medtronic. Other - Research Support, Speaker, Consultant; Current; Dexcom, Inc. Research Support; Current; Abbott. Other - Research Support, Speaker, Consultant; Current; Insulet Corporation, Tandem Diabetes Care, Inc. Research Support; Current; MannKind Corporation. Other - Research Support, Consultant; Current; Sequel. D. Kruger: Advisory Panel; Current; Abbott Diabetes. Speaker's Bureau; Current; Abbott. Advisory Panel; Current; Dexcom, Inc. Speaker's Bureau; Current; Dexcom, Inc. Research Support; Current; Abbott Diabetes. Advisory Panel; Current; Eli Lilly and Company. Speaker's Bureau; Current; Eli Lilly and Company. Advisory Panel; Current; Novo Nordisk. Speaker's Bureau; Current; Novo Nordisk. Research Support; Current; Insulet Corporation. Advisory Panel; Current; MannKind Corporation, Medtronic, Provention Bio, Inc., CeQur SA, Corcept Therapeutics. Speaker's Bureau; Current; CeQur SA, Corcept Therapeutics. Research Support; Current; Abbott Diabetes. Speaker's Bureau; Current; Sanofi. Advisory Panel; Current; Tandem Diabetes Care, Inc. Speaker's Bureau; Current; Tandem Diabetes Care, Inc. Research Support; Current; Tandem Diabetes Care, Inc. Advisory Panel; Current; Insulet Corporation. Speaker's Bureau; Current; Insulet Corporation. Consultant; Current; Sequel. Speaker's Bureau; Current; sequel. Research Support; Current; sequel. K. Castorino: Research Support; Current; Abbott, Abbott Diabetes. Research Support; Ended; Altimmune. Research Support; Current; Dexcom, Inc. Speaker's Bureau; Current; Dexcom, Inc. Research Support; Current; Eli Lilly and Company. Advisory Panel; Current; MannKind Corporation. Speaker's Bureau; Current; Insulet Corporation. Consultant; Ended; Sequel Med Tech. G. Aleppo: Advisory Panel; Current; Medscape, Tandem Diabetes Care, Inc. Consultant; Current; Eli Lilly and Company, Dexcom, Inc., Insulet Corporation. Research Support; Current; AbbVie Inc., Bayer, Fractyl, Insulet Corporation, MannKind Corporation, Tandem Diabetes Care, Inc., Medtronic. D.J. DeSalvo: Consultant; Current; Dexcom, Inc., Insulet Corporation. Advisory Panel; Current; Sanofi. Research Support; Current; Medtronic. M. Kipnes: None. A. Peters: Advisory Panel; Current; Vertex Pharmaceuticals Incorporated, Medscape. Research Support; Ended; Abbott Diabetes. Research Support; Current; Insulet Corporation, Zucara Therapeutics. Stock/Shareholder; Current; Omada Health, Inc. J. Sherr: Other - research support, consultant, advisory board member; Current; Abbott Diabetes. Other - advisory board member, consultant; Current; Vertex Pharmaceuticals Incorporated. Consultant; Current; Ypsomed AG. Research Support; Current; Dexcom, Inc., JDRF, Provention Bio, Inc., National Institutes of Health. Other - research support, consultant, advisory board member; Current; Insulet Corporation, Medtronic. Research Support; Current; Sanofi. Advisory Panel; Current; sequel med tech. A. Criego: Other - I am contracted for my time through my employer HealthPartners Institute dba International Diabetes Center with no direct financial compensation to me personally.; Current; Abbott Diabetes. Other - Research, Advisory Board and Speakers Bureau involvement is contracted for my time through my employer HealthPartners Institute dba International Diabetes Center with no direct financial compensation to me personally.; Current; Insulet Corporation. Other - Research involvement is contracted for my time through my employer HealthPartners Institute dba International Diabetes Center with no direct financial compensation to me personally.; Current; Medtronic. Other - I am contracted for my time through my employer HealthPartners Institute dba International Diabetes Center with no direct financial compensation to me personally.; Current; Medscape, Dexcom, Inc. S. MacLeish: Speaker's Bureau; Current; Insulet Corporation. Research Support; Current; Insulet Corporation, Dexcom, Inc., Medtronic. A. Carlson: Research Support; Current; Abbott Diabetes, Dexcom, Inc., Eli Lilly and Company. Other - Research support and consulting/speaking; Current; Insulet Corporation. Research Support; Current; Lexicon Pharmaceuticals, Inc. Advisory Panel; Current; MannKind Corporation. Other - Research support and advisory panel; Current; Medtronic, Novo Nordisk A/S, Zealand Pharma A/S. Advisory Panel; Current; Tandem Diabetes Care, Inc. D. Raghinaru: None. R.W. Beck: Research Support; Current; MannKind Corporation, Abbott Diabetes, Dexcom, Inc., Tandem Diabetes Care, Inc., Sequel Med Tech, DreaMed Diabetes, Ltd. Consultant; Ended; Novo Nordisk, Eli Lilly and Company. Consultant; Current; Zucara Therapeutics. T.T. Ly: Employee; Current; Insulet Corporation. Stock/Shareholder; Current; Insulet Corporation. L.M. Laffel: Other - Travel support for scientific presentations; Ended; Boehringer Ingelheim International GmbH. Other - DSMB Chair; Ended; Janssen Pharmaceuticals, Inc. Consultant; Current; Dexcom, Inc. Advisory Panel; Current; Medtronic, Sequel, Tandem Diabetes Care, Inc. Consultant; Current; Roche Diabetes Care, Sinocare. Advisory Panel; Ended; Sanofi. Advisory Panel; Current; MannKind Corporation. Funding This study was funded by Insulet Corporation.

Importance:There is a need for additional treatment options for people with type 2 diabetes treated with insulin. Given the limited data on the use of automated insulin delivery (AID) systems in type 2 diabetes, studies evaluating their safety and efficacy are important. Objective:To evaluate the association of AID with hemoglobin A1c (HbA1c) levels in a diverse cohort of adults with type 2 diabetes. Design, Setting, and Participants:This single-arm prospective trial was conducted at 21 clinical centers in the United States among individuals aged 18 to 75 years with type 2 diabetes who had been using insulin for at least 3 months prior to screening. Participants with AID system use were excluded. The study started with a 14-day standard therapy phase, followed by 13 weeks of treatment with the investigational device. The first participant was enrolled April 11, 2023, and the last participant follow-up visit was February 29, 2024. Intervention:Participants used the Omnipod 5 AID System for 13 weeks following the 14-day standard therapy phase. Main Outcomes and Measures:Primary outcome was change in HbA1c level at 13 weeks, tested sequentially for noninferiority (0.3% margin) and superiority, compared with baseline. Results:Among 305 participants (mean [SD] age, 57 [11] years; 175 [57%] female; 72 [24%] Black, 66 [22%] Hispanic or Latino, and 153 [50%] White), 289 (95%) completed the trial. At baseline, 223 (73%) were using multiple daily injections, 63 (21%) were using basal insulin without bolus, 17 (6%) were using an insulin pump, 188 (62%) were using continuous glucose monitoring, 168 (55%) were using glucagon-like peptide-1 receptor agonists (GLP-1RAs), and 134 (44%) were using sodium-glucose transport protein 2 inhibitors (SGLT-2is). Following AID use, HbA1c levels decreased from a mean (SD) of 8.2% (1.3) at baseline to 7.4% (0.9) at 13 weeks (mean difference, -0.8 [95% CI, -1.0 to -0.7] percentage points; P < .001 for noninferiority and superiority). Improvement was seen across various subgroups (age, sex, race and ethnicity, insurance), and notably with or without use of GLP-1RAs or SGLT-2is and regardless of pretrial mealtime insulin regimen. Time in target glucose range (70-180 mg/dL) increased from a mean (SD) of 45% (25) to 66% (17) (mean difference, 20 [95% CI, 18 to 22] percentage points; P < .001). Percentage of time in hypoglycemic ranges of less than 54 mg/dL and less than 70 mg/dL was noninferior compared with standard therapy. There was 1 episode of severe hypoglycemia and none of diabetic ketoacidosis or hyperosmolar hyperglycemic syndrome. Conclusions and Relevance:In this nonrandomized clinical trial, HbA1c levels were lower in a diverse cohort of adults with type 2 diabetes following AID initiation, suggesting that AID may be a beneficial and safe option for people with type 2 diabetes using insulin. Trial Registration:ClinicalTrials.gov Identifier: NCT05815342.

Objective: To evaluate a regimen of inhaled technosphere insulin (TI) plus insulin degludec in adults with type 1 diabetes, who prestudy were predominately using either an automated insulin delivery system (AID) or multiple daily insulin injections (MDI) with continuous glucose monitoring (CGM). Research Design and Methods: At 19 sites, adults with type 1 diabetes were randomly assigned to TI plus insulin degludec (TI group, N=62) or usual care with continuation of pre-study insulin delivery method (UC group, N=61) for 17 weeks. Results: Prestudy, AID was being used by 48% and MDI by 45%. Mean HbA1c was 7.57±0.97% at baseline and 7.62±1.06% at 17 weeks in the TI group and 7.59±0.80% and 7.54±0.77%, respectively, in the UC group (adjusted difference = 0.11%, 95% CI -0.10 to 0.33, p-value for non-inferiority = 0.01). HbA1c improved from baseline to 17 weeks by >0.5% (5.5mmol/mol) in 12 (21%) in the TI group and in 3 (5%) in the UC group and worsened by >0.5% (5.5mmol/mol) in 15 (26%) in the TI group and in 2 (3%) in the UC group. The most common TI side effect was a brief cough; 8 participants discontinued TI due to side effects. Conclusions: In adults with type 1 diabetes, HbA1c after 17 weeks with a regimen of TI and degludec was non-inferior to usual care, which consisted predominately of either AID or MDI. TI should be considered an option for people with type 1 diabetes, particularly those who are motivated to further reduce post-prandial hyperglycemia.

Importance There is a need for additional treatment options for people with type 2 diabetes treated with insulin. Given the limited data on the use of automated insulin delivery (AID) systems in type 2 diabetes, studies evaluating their safety and efficacy are important. Objective To evaluate the association of AID with hemoglobin A 1c (HbA 1c ) levels in a diverse cohort of adults with type 2 diabetes. Design, Setting, and Participants This single-arm prospective trial was conducted at 21 clinical centers in the United States among individuals aged 18 to 75 years with type 2 diabetes who had been using insulin for at least 3 months prior to screening. Participants with AID system use were excluded. The study started with a 14-day standard therapy phase, followed by 13 weeks of treatment with the investigational device. The first participant was enrolled April 11, 2023, and the last participant follow-up visit was February 29, 2024. Intervention Participants used the Omnipod 5 AID System for 13 weeks following the 14-day standard therapy phase. Main Outcomes and Measures Primary outcome was change in HbA 1c level at 13 weeks, tested sequentially for noninferiority (0.3% margin) and superiority, compared with baseline. Results Among 305 participants (mean [SD] age, 57 [11] years; 175 [57%] female; 72 [24%] Black, 66 [22%] Hispanic or Latino, and 153 [50%] White), 289 (95%) completed the trial. At baseline, 223 (73%) were using multiple daily injections, 63 (21%) were using basal insulin without bolus, 17 (6%) were using an insulin pump, 188 (62%) were using continuous glucose monitoring, 168 (55%) were using glucagon-like peptide-1 receptor agonists (GLP-1RAs), and 134 (44%) were using sodium-glucose transport protein 2 inhibitors (SGLT-2is). Following AID use, HbA 1c levels decreased from a mean (SD) of 8.2% (1.3) at baseline to 7.4% (0.9) at 13 weeks (mean difference, −0.8 [95% CI, −1.0 to −0.7] percentage points; P < .001 for noninferiority and superiority). Improvement was seen across various subgroups (age, sex, race and ethnicity, insurance), and notably with or without use of GLP-1RAs or SGLT-2is and regardless of pretrial mealtime insulin regimen. Time in target glucose range (70-180 mg/dL) increased from a mean (SD) of 45% (25) to 66% (17) (mean difference, 20 [95% CI, 18 to 22] percentage points; P < .001). Percentage of time in hypoglycemic ranges of less than 54 mg/dL and less than 70 mg/dL was noninferior compared with standard therapy. There was 1 episode of severe hypoglycemia and none of diabetic ketoacidosis or hyperosmolar hyperglycemic syndrome. Conclusions and Relevance In this nonrandomized clinical trial, HbA 1c levels were lower in a diverse cohort of adults with type 2 diabetes following AID initiation, suggesting that AID may be a beneficial and safe option for people with type 2 diabetes using insulin. Trial Registration ClinicalTrials.gov Identifier: NCT05815342

Background: This study evaluates the performance of a 15-day factory-calibrated continuous glucose monitoring sensor used in FreeStyle Libre 2 Plus (Libre 2 Plus) and FreeStyle Libre 3 Plus (Libre 3 Plus) Systems, featuring an improved sensor design to reduce vitamin C interference. Methods: Participants aged 2 years and above were enrolled for this study at seven sites in the United States. Depending on their age and bodyweight, participants attended up to three in-clinic sessions where venous blood was obtained for comparator measurement. For 2- to 5-year-olds, only capillary comparator data were collected. Participants aged 11 years and older underwent supervised glycemic manipulation to achieve glucose levels across the sensor’s measurement range. Performance measures included the proportion of continuous glucose monitoring (CGM) values within ±20%/±20 mg/dL of comparator glucose values and mean absolute relative difference (MARD) between CGM and comparator values. Results: Of the total 332 participants enrolled in the study, 149 adults and 124 pediatric participants (ages 6-17 years) had paired data for analysis against YSI comparator. Percentages within ±20 mg/dL/20% were 94.2% and 94.0%, and MARDs were 8.2% and 8.1% for the adults and pediatric participants, respectively. For 12 pediatric participants of 2 to 5 years, the percentage within ±20 mg/dL/20% was 86.6%, with an MARD of 11.2% against self-monitoring of blood glucose (SMBG) comparator. The sensor performed well in the hypoglycemic range, with 97.1% and 98.0% of results within ±15 mg/dL of the YSI comparator for the adult and pediatric participants, respectively. Conclusions: The Libre 2 Plus and Libre 3 Plus Systems provide accurate glucose results across the dynamic range during the 15-day sensor wear period.

Background: Continuous glucose monitors (CGM) are increasingly being used to manage diabetes. We evaluated the performance and safety of an investigational 15-day G7 integrated CGM (iCGM; Dexcom) in adults with diabetes. Methods: This prospective, multicenter study enrolled adults (age ≥18 years) with type 1 diabetes (T1D) or type 2 diabetes (T2D) at six clinical sites in the United States. Four in-clinic visits were conducted on days 1-3, 4-7, 9-12, and 13-15.5, with frequent arterialized venous blood draws for comparator measurements using a Yellow Springs Instrument (YSI) 2300 Stat Plus glucose analyzer. Participants with T1D or T2D using intensive insulin therapy participated in clinic sessions with deliberate, closely monitored glucose manipulations. Accuracy evaluations included the mean absolute relative difference (MARD), proportion of CGM values within 15 mg/dL of YSI values <70 mg/dL or within 15% of YSI values ≥70 mg/dL (%15/15), as well as %20/20, %30/30, and %40/40 agreement rates. Performance related to iCGM special controls, user experience, and device safety were also assessed. Results: The study enrolled 130 adults with diabetes (mean ± standard deviation age 43.0 ± 14.4 years, 53.1% female, 86.9% with T1D) and analyzed 20,310 CGM-YSI matched pairs from 130 15-day G7 CGM devices. The overall MARD was 8.0% and the %15/15, %20/20, %30/30, and %40/40 agreement rates were 87.7%, 94.2%, 98.9%, and 99.8%, respectively. The device exceeded iCGM performance goals, and user experiences were broadly positive. No serious adverse events were reported. Conclusions: The 15-day G7 iCGM was accurate and safe in adults with diabetes throughout the 15.5-day wear period. Clinicaltrials.gov: NCT05263258.

ABSTRACT Introduction Predicting pregnancy is a challenge in preconception weight loss intervention trials. The current study examined whether self‐reported pregnancy likelihood and timing were predictive of conception. Methods Adults (n = 184; 58% Hispanic; age = 33.4 ± 5.1; BMI = 33.6 ± 6.6) with overweight or obesity, prior gestational diabetes mellitus, and plans to become pregnant participated in a pre‐conception behavioral weight loss intervention or control. At baseline, participants reported their estimated likelihood of pregnancy from 1 to 10 (categorized as low [1–3], medium [4–7], and high [8–10] likelihood); they also reported expected timeframe for pregnancy. Results Over the 4‐year trial, 62 (30%) participants became pregnant. Participants who reported a high likelihood of pregnancy were more likely to conceive than those with a lower rating (45.7% vs. 21.1%). The sensitivity and specificity of a high likelihood rating predicting conception were 69%, 95% CI (56.2%, 80.1%), and 58%, 95% CI (48.9%, 67.0%), respectively. Among those who conceived, mean expected time to pregnancy was 21.6 ± 13.2 months while actual mean time was 11.3 ± 9.1 months. Baseline age, ethnicity, parity, BMI, income, and other demographics did not predict conception. Conclusions Pregnancy likelihood estimates best predicted conception, but sensitivity and specificity were low. Future work may consider additional ways to screen for likelihood of conception in preconception trials.

Hispanic/Latino (H/L) adults are disproportionately affected and have suboptimal control of Type 2 Diabetes (T2DM). We hypothesize that use of a Spanish-language smartphone application with structured blood glucose (BG) monitoring and proactive diabetes coaching (mySugr® PRO) will improve diabetes self-efficacy, weight, and glucose control in H/L adults with uncontrolled T2DM. Spanish-literate H/L adults with non-intensively treated T2DM and HbA1c 7.5-10.0% were enrolled. Subjects were provided with an Accu-Chek® Guide Me glucometer, trained on use of mySugr® PRO, received education on structured BG monitoring (paired testing before and 2hr post-meal), and given access to diabetes coaching. BG metrics, HbA1c, weight, waist circumference, diabetes self-efficacy and distress were measured before and after 12-weeks; acceptability & quality of the app were evaluated after 12 weeks. H/L adults (22) were enrolled, and 11 have completed to date. Subjects achieved significant reductions in HbA1c, weight, and waist circumference when compared to baseline. Diabetes self-efficacy and distress improved non-significantly. MySugr® PRO was well accepted and perceived to be useful by H/L adults with uncontrolled T2DM. Diabetes self-efficacy and distress improved, and the app provided them with motivation and intention to improve BG control. Disclosure A.A. Thorsell: None. W.C. Bevier: None. K.N. Castorino: Research Support; Abbott, Dexcom, Inc. Speaker's Bureau; Dexcom, Inc. Research Support; Lilly Diabetes, Medtronic, MannKind Corporation, Insulet Corporation. Consultant; Medscape. D. Kerr: Advisory Panel; Abbott Diagnostics. Consultant; Sanofi, Better Therapeutics, Inc. Stock/Shareholder; Glooko, Inc. B. Ulmer: Employee; Roche Diabetes Care. E. Repetto: Employee; Roche Diabetes Care. K. Gonzalez: None. L. Melero: None.

Gestational diabetes mellitus (GDM) is the most prevalent metabolic complication during pregnancy. GDM is associated with adverse perinatal, neonatal, and long-term health consequences. Studies have demonstrated that the use of continuous glucose monitoring (CGM) reduces the incidence of maternal and neonatal complications in pregnant women with type 1 diabetes. Although the use of CGM in GDM has not been well studied, a growing body of evidence is showing potential benefits in the GDM population. This article discusses the advantages and challenges of CGM and provides practical guidelines for using this technology in the GDM population.