American Diabetes AssociationSource Reference: Dandona P, et al "Liraglutide as an Additional Treatment to Insulin in Patients with Type 1 Diabetes Mellitus–A 52-Week Randomized Double-Blinded Placebo-Controlled Clinical Trial" ADA 2018; Abstract 3-LB.
2重盲検46名のトライアル
そして、ケトアシドーシスが怖そうなsotagliflozin治療
American Diabetes AssociationSource Reference: Buse J, et al "212-OR - Fifty-Two-Week Efficacy and Safety of Sotagliflozin, a Dual SGLT1 and SGLT2 Inhibitor, as Adjunct Therapy to Insulin in Adults with Type 1 Diabetes (inTandem1)" ADA 2018; Abstract 212-OR.
安全性を示してはいるが・・・
そして、第2世代人工膵臓の話・・・
↓
CGMとインスリンポンプを組み合わせた“人工膵臓”
アミリンと即効型インスリンの2つのホルモンを組み合わせの人工膵臓により1型糖尿病の食後血糖を改善
Insulin-plus-Pramlintide Artificial Pancreas in Type 1 Diabetes—Randomized Controlled Trial
https://plan.core-apps.com/tristar_ada18/abstract/807d2f9885450670bb994661e3654056
12名の1型糖尿病で 以下比較
i) dual-hormone, rapid insulin and amylin (Pramlintide), artificial pancreas (DAP)
ii) regular insulin (Humulin R) and amylin artificial pancreas (R-DAP)
iii) rapid insulin-alone artificial pancreas (AP)
インスリンとアミリンはbasal-bolus法にて同時投与、新しいどうよアルゴリズム、固定比率6μg/u、合剤疑似的
24時間に3回受診してもらい、3食及び夜食を摂ってもらう。
closed-loop研究に先立ち、アミリンを2週間東予市、basal比率とcarb比率を最適化する
| Outcome | AP | DAP | R-DAP | P-value DAP vs. AP | P-value R-DAP vs. AP |
| Time spent between 3.9 and 10.0 mmol/L during 24-hour study period (%) | 71 ± 19 | 85 ± 10 | 72 ± 16 | 0.03 | 0.86 |
| Mean glucose level during 24-hour study period (mmol/L) | 8.2 ± 1.3 | 7.4 ± 1.1 | 7.7 ± 0.8 | 0.07 | 0.38 |
| Coefficient of variance during 24-hour study period (%) | 34 ± 11 | 25 ± 6 | 35 ± 8 | 0.01 | 0.65 |
| Time spent between 3.9 and 10.0 mmol/L during daytime period (%) | 58 ± 26 | 78 ± 16 | 66 ± 21 | 0.02 | 0.58 |
| Mean glucose level during daytime period (mmol/L) | 9.1 ± 1.9 | 7.8 ± 1.5 | 8.4 ± 1.5 | 0.02 | 0.34 |
| Time spent between 3.9 and 7.8 mmol/L during overnight period (%) | 77 ± 20 | 71 ± 29 | 65 ± 19 | 0.47 | 0.16 |
| Mean glucose level during overnight period (mmol/L) | 6.6 ± 0.9 | 6.8 ± 0.9 | 6.6 ± 1.2 | 0.51 | 0.87 |
24時間研究にて、DAPではAPに比べ目標レンジ [3.9-10.0 mmol/L] 時間増加 72%→85%(p=0.03)
血糖変動(CV)減少 34% → 25%(P=0.01)するも、低血糖リスク増加せず (P=NS)
きびしい目標レンジ [3.9-7.8 mmol/L]到達比率は、DAP、APとも同様 77%, 71%, P=NS
中等度吐気 DAP 2例 vs AP 0
日中・夜間においてAP比較のR-DAPのベネフィット相関認めず
速効インスリン＋アミリン固定比率によるdual-hormone人工膵臓システムは、インスリン単独第１世代に比較して血糖コントロール改善し血糖変動を減少
https://www.prnewswire.com/news-releases/dual-hormone-artificial-pancreas-with-insulin-and-pramlintide-significantly-improves-glucose-levels-compared-to-insulin-only-artificial-pancreas-300671183.html
