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
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