Background: For some with type 1 diabetes (T1D) , hybrid closed-loop insulin therapy is insufficient to achieve glycemic targets. Low doses of SGLT2i may improve glycemia in those not able to achieve their targets. Methods: A double-blinded, cross-over, randomized controlled trial was performed in sub-optimally controlled (HbA1c 7.0-10.5%) adults with T1D who were not able to achieve a time-in-range (3.9-10.0 mmol/L) of > 70% after 14 days on closed-loop therapy. Three 14-day interventions were performed with placebo, empagliflozin 2.5 mg, or empagliflozin 5 mg, as adjunct to closed-loop therapy, with daily ketone testing. Results: 24 participants completed the study (50% male, age 33 ± 14 yrs, HbA1c 8.1 ± 0.5%) . The time in range was 59 ± 9% for placebo, 72 ± 10% for empagliflozin 2.5 mg, and 70 ± 8 for empagliflozin 5 mg (p < 0.between placebo and empagliflozin 2.5 mg, and placebo and empagliflozin 5 mg) . Empagliflozin 2.5 mg did not increase time spent below 3.9 mmol/L though empagliflozin 5 mg did (p = 0.01) . Average ketone levels were not different between arms (p=ns) . There were no serious adverse events in any intervention. Conclusion: Both empagliflozin 2.5 mg and 5 mg increased the time spent in target on hybrid closed-loop therapy by 11-13 % compared to placebo, in those who otherwise were unable to attain glycemic targets. Disclosure M.Pasqua: None. A.Jafar: None. A.Kobayati: None. M.Tsoukas: Speaker's Bureau; AstraZeneca, Bausch Health, Canada, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Johnson & Johnson, Novo Nordisk Canada Inc. A.Haidar: Consultant; Eli Lilly and Company, Research Support; ADOCIA, Dexcom, Inc., Eli Lilly and Company, Tandem Diabetes Care, Inc. Funding National Institutes of Health (1DP3DK106930)
We conducted a randomized, controlled, pilot study to eliminate carbohydrate counting (CC) in adults with type 1 diabetes using an automated insulin (insulin aspart and faster aspart) and pramlintide dual-pump fully closed-loop delivery system. The interventions included 5 arms (n = 11, 8 F, A1C 7.4%) and participants underwent 14 hours of outpatient, free-living, supervised interventions of (i) faster aspart with CC, (ii) faster aspart and pramlintide at a 1u:8µg ratio without CC, and (iii) faster aspart and pramlintide (1:10) without CC (iv) insulin aspart and pramlintide (1:8) without CC, and (v) insulin aspart and pramlintide (1:10) without CC. One participant opted out of the two insulin aspart and pramlintide arms. Prior to each dual-hormone intervention, participants had a 2-4-day drug dose-escalation period. P-values are not reported as this is an underpowered pilot study. During the faster aspart and pramlintide interventions, the mean time in target range (70-180 mg/dL) was 69% (24%) and 77% (13%) with the 1:8 and 1:10 ratios, respectively. During the aspart and pramlintide interventions, the time in range was 71% (15%) and 77% (11%) with the 1:8 and 1:10 ratios, respectively. Compared to the control arm where time in range was 72% (26%), both the insulin aspart and faster aspart arms with the 1:10 ratio provided numerical improvements to time in range. The median time spent below 54mg/dL with each respective ratio was 1.3% (0, 4.5), 0.6% (0, 2.4) on the aspart arms and 0.0% in the faster aspart and control arms. The mean total insulin used throughout the interventions was 38.2 (23.5) units on the control arm, 31.8 (18.4) and 32.5 (17.5) on the faster aspart 1:8 and 1:10 respectively, and 36.6 (26.9) and 32.2 (23.5) on the insulin aspart 1:8 and 1:10 arms respectively. This pilot study suggests that our fully automated dual-hormone delivery system has the potential to alleviate carbohydrate counting without degrading time in the target range; and it will be investigated in a larger subsequent study. Disclosure M.Odabassian: None. M.Tsoukas: Speaker's Bureau; Novo Nordisk Canada Inc., Boehringer Ingelheim (Canada) Ltd., Eli Lilly and Company, Janssen Scientific Affairs, LLC, AstraZeneca, Sanofi. E.Cohen: None. M.Pasqua: None. J.Rutkowski: None. A.Haidar: Consultant; Eli Lilly and Company, Other Relationship; Bigfoot Biomedical, Inc., Research Support; Adocia, Dexcom, Inc., Tandem Diabetes Care, Inc.
We conducted a non-inferiority randomized crossover trial to alleviate carbohydrate counting (CC) in people with diabetes using automated dual-pump delivery of faster aspart (Fiasp) and pramlintide. Adults (N=15, 9 F, 39 ± 14 years, A1c 7.2 ± 0.9%) and adolescents (N=15, 8 F, 16 ± 1 years, A1c 8.4 ± 0.9%) used (i) Fiasp and placebo with CC, (ii) Fiasp and pramlintide with meal announcement (MA) , and (iii) Fiasp and placebo with MA for 2 weeks. Fiasp and pramlintide were delivered at a fixed 1 U:µg ratio to mimic a co-formulation. MA arms delivered fixed, user-specific priming meal boluses, independent of carbohydrate content. Prior to the first arm, participants had a 1-week run-in with automated Fiasp (single pump) delivery and CC, with mean time in range (70-180 mg/dL) of 71% in adults and 64% in adolescents. In adults, mean time in range was 65% on Fiasp and placebo with CC, 71% on Fiasp and pramlintide with MA, and 64% on Fiasp and placebo with MA; non-inferiority with a pre-defined 6.25% margin was achieved in both MA arms with pramlintide and placebo (difference -6 [95% CI -12.6, 0.5]; 1 [-3.0, 4.6]) . In adolescents, mean time in range was 51%, 55%, and 46% in the three respective arms; non-inferiority was only achieved on Fiasp and pramlintide with MA (-4 [-9.0, 1.7]) . We conclude that automated Fiasp and pramlintide delivery may alleviate CC without degrading glucose control. Disclosure E.Cohen: None. E.Palisaitis: Other Relationship; Eli Lilly and Company. J.Rutkowski: None. L.Legault: Advisory Panel; Abbott Diabetes, Insulet Corporation, Novo Nordisk A/S, Other Relationship; Eli Lilly and Company, Research Support; AstraZeneca, Merck & Co., Inc. A.Haidar: Consultant; Eli Lilly and Company, Research Support; ADOCIA, Dexcom, Inc., Eli Lilly and Company, Tandem Diabetes Care, Inc. M.Tsoukas: Speaker's Bureau; AstraZeneca, Bausch Health, Canada, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Johnson & Johnson, Novo Nordisk Canada Inc. J.E.Von oettingen: None. J.Yale: Advisory Panel; Bayer AG, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Novo Nordisk Canada Inc., Sanofi, Research Support; Bayer AG, Speaker's Bureau; Abbott Diabetes, AstraZeneca, Bayer AG, Dexcom, Inc., Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk Canada Inc., Sanofi. N.Garfield: None. M.Vallis: Advisory Panel; Bausch Health, Canada, Novo Nordisk Canada Inc., Consultant; Abbott Diabetes, LifeScan, Speaker's Bureau; AbbVie Inc., Bausch Health, Canada, LifeScan, Novo Nordisk, Novo Nordisk A/S. N.Gouchie-provencher: None. A.Jafar: None. M.Ghanbari: None. Funding Juvenile Diabetes Research Foundation International (2-SRA-2018-654-M-B) , Canada Research Chairs
Obesity is an increasing concern in patients with type 1 diabetes. Bariatric surgery is an effective option for weight loss and is associated with an improvement in metabolic complications. We report 2 cases of adults with type 1 diabetes using automated insulin delivery where laparoscopic sleeve gastrectomy was complicated post-operatively by euglycemic ketoacidosis. The first case was of a 28-year-old man using Control-IQ (HbA1c 7.3%, body mass index 40, and insulin requirements 0.98 Units/kg/day). His insulin requirements and carbohydrate intake decreased from 108 units and 208 grams respectively to 44 units and 8 grams during the preoperative liquid diet. His lack of carbohydrate consumption continued post-operatively. Two days after his surgery, he presented to the emergency department with nausea, where his glucose level was 12.8 mmol/L, venous pH level 7.30, venous bicarbonate concentration 20.9 mmol/L, and plasma beta-hydroxybutyrate 4.5 mmol/L. He was treated with intravenous hydration with supplementation dextrose with observation. The second case was of a 33-year-old woman using the MiniMed 770G (HbA1c 7.0%, body mass index 44, insulin requirements 0.4 units/kg/day). Post-operative day 16, she presented to the emergency department with nausea and vomiting. Her glucose level was 11.9 mmol/L venous pH was 7.31, venous bicarbonate was 17 mmol/L, and positive urinary ketones. Daily insulin requirements had reduced (from preoperatively to post-operatively) from 35.8 to 16.3 Units per day, with her carbohydrate intake from 86 to 33 grams. She was treated with intravenous insulin. Though euglycemic ketoacidosis is documented after bariatric surgery and starvation, automated insulin delivery (particularly unnoticed insulin changes) may have influenced glycemia and acidosis. Careful review of insulin administration, carbohydrate intake, and ketone monitoring is recommended in these cases. Disclosure M.Pasqua: None. M.Tsoukas: Speaker's Bureau; Novo Nordisk Canada Inc., Boehringer Ingelheim (Canada) Ltd., Eli Lilly and Company, Janssen Scientific Affairs, LLC, AstraZeneca, Sanofi. W.Hu: None.
The change in HbA1c after initiating FreeStyle Libre or FreeStyle Libre 2 Flash Glucose Monitoring System (FSL and FSL2) in adults with type 2 diabetes (T2D) in a real-world setting was evaluated over a 3-6 month period. Nine sites in Canada collected medical record data prospectively for adults who had started FSL or FSL2 in the last 3 months and with the following criteria: a basal insulin regimen with or without additional glucose lowering medications, and HbA1c 8.0-12.0%. Preliminary data were analysed from 79/138 medical records (n=138; 6 records ineligible, 53 no follow up, ineligible HbA1c or had stopped FSL or FSL2). Participants had the following baseline characteristics (mean±SD): HbA1c 8.9%±0.8, age 67.3±11.5 years (57% ≥65 years), BMI 30.1±6.2 (n=65), insulin use duration 5.3±3.9 years, and 54% were males. The most commonly used non-insulin glucose lowering medications included metformin (87.3%), sodium-glucose co-transporter-2 (SGLT2) inhibitors (62.0%) and sulphonylureas (46.8%). By the end of the study (3-6 months after the index date), mean HbA1c was reduced by 0.6%±1.1 to 8.3%±1.0 (p<0.0001). Observed changes in antihyperglycemic medications from baseline included increased use of GLP-1 agonists from 44.3% to 51.9% and decreased use of DPP4i from 24.1% to 16.5%. This prospective chart review study found that initiating intermittently scanned continuous glucose monitoring in individuals with T2D treated with basal insulin plus other glucose lowering medications was associated with significantly improved HbA1c over a 3-6 month period. Disclosure A. Abitbol: Advisory Panel; Abbott Diabetes, Lilly Diabetes, Dexcom, Inc., Novo Nordisk Canada Inc., Janssen Pharmaceuticals, Inc., Research Support; Abbott Diabetes, Lilly Diabetes, Zucara Therapeutics, Novo Nordisk Canada Inc., Moderna, Inc., Senseonics, Speaker's Bureau; Boehringer Ingelheim (Canada) Ltd., Lilly Diabetes, Amgen Canada, Dexcom, Inc., Novo Nordisk Canada Inc., HLS Therapeutics Inc., Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Sanofi. A. B. Jain: Advisory Panel; Abbott, Amgen Canada, Dexcom, Inc., AstraZeneca, Novo Nordisk, Bayer Inc., Insulet Corporation, Takeda Canada, Boehringer Ingelheim (Canada) Ltd., Eli Lilly and Company, Research Support; Abbott, Amgen Canada, Novo Nordisk, Speaker's Bureau; Abbott, Amgen Canada, Dexcom, Inc., AstraZeneca, Novo Nordisk, Bausch Health, Canada, Boehringer Ingelheim (Canada) Ltd., Eli Lilly and Company, Pfizer Inc. M. Tsoukas: Speaker's Bureau; Novo Nordisk Canada Inc., Boehringer Ingelheim (Canada) Ltd., Eli Lilly and Company, Janssen Scientific Affairs, LLC, AstraZeneca, Sanofi. J. Sigalas: None. B. P. Galm: Advisory Panel; Abbott, Boehringer Ingelheim (Canada) Ltd., Novo Nordisk Canada Inc., Pfizer Inc., Research Support; Abbott, Speaker's Bureau; Abbott, Dexcom, Inc., Pfizer Inc. J. Lee: Advisory Panel; Amgen Canada, Research Support; Novo Nordisk, Lilly, Abbott, Speaker's Bureau; Amgen Canada, Canadian Collaborative Research Network, AstraZeneca, Pfizer Inc. K. S. Qureshy: Advisory Panel; Novo Nordisk, Other Relationship; Novo Nordisk, Novo Nordisk, Research Support; Abbott Diagnostics, Novo Nordisk, Speaker's Bureau; AstraZeneca. C. Collins: None. V. C. Woo: Advisory Panel; Abbott, Speaker's Bureau; Dexcom, Inc. Funding Abbott Diabetes Care
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