Insulin-plus-Pramlintide Artificial Pancreas in Type 1 Diabetes—Randomized Controlled Trial
Notice bibliographique
Résumé
We conducted a randomized crossover comparison between i) dual-hormone, rapid insulin and amylin (Pramlintide), artificial pancreas (DAP), ii) regular insulin (Humulin R) and amylin artificial pancreas (R-DAP), and iii) rapid insulin-alone artificial pancreas (AP) in 12 adults with type 1 diabetes. Insulin and amylin were delivered simultaneously, in a basal-bolus manner, using a novel dosing algorithm, with a fixed ratio (6 µg/u), mimicking a co-formulation. Participants were admitted three times for 24 hours and ingested three meals and a bedtime snack. Prior to closed-loop study, amylin was delivered for two weeks, and basal rates and carb ratios were optimized. Over the 24-hour study, DAP increased time spent in target range [3.9-10.0 mmol/L] compared to AP from 71% to 85% (P=0.03) and decreased glucose variability (CV) from 34% to 25% (P=0.01), without increasing the risk of hypoglycemia (P=NS). Overnight, DAP and AP achieved high and similar time in tight target range [3.9-7.8 mmol/L; 77%, 71%, P=NS]. Moderate nausea was reported by two participants (16%) on DAP compared to 0 (0%) on AP. There was no benefits associated with R-DAP compared to AP during day or night period. We conclude that a dual-hormone artificial pancreas delivering rapid insulin and amylin with fixed ratio improves glucose control and reduces glucose variability compared to insulin-alone, first-generation, artificial pancreas.Table 1.Comparisons between AP, DAP, and R-DAP (mean±SD)OutcomeAPDAPR-DAPP-value DAP vs. APP-value R-DAP vs. APTime spent between 3.9 and 10.0 mmol/L during 24-hour study period (%)71 ± 1985 ± 1072 ± 160.030.86Mean glucose level during 24-hour study period (mmol/L)8.2 ± 1.37.4 ± 1.17.7 ± 0.80.070.38Coefficient of variance during 24-hour study period (%)34 ± 1125 ± 635 ± 80.010.65Time spent between 3.9 and 10.0 mmol/L during daytime period (%)58 ± 2678 ± 1666 ± 210.020.58Mean glucose level during daytime period (mmol/L)9.1 ± 1.97.8 ± 1.58.4 ± 1.50.020.34Time spent between 3.9 and 7.8 mmol/L during overnight period (%)77 ± 2071 ± 2965 ± 190.470.16Mean glucose level during overnight period (mmol/L)6.6 ± 0.96.8 ± 0.96.6 ± 1.20.510.87 Disclosure A. Haidar: Consultant; Self; Eli Lilly and Company. Research Support; Self; AgaMatrix, Medtronic MiniMed, Inc. M. Tsoukas: Speaker's Bureau; Self; Janssen Pharmaceuticals, Inc., Novo Nordisk Inc.. Advisory Panel; Self; Sanofi. Speaker's Bureau; Self; Eli Lilly and Company. S. Twardy: None. N. Strauss: None. J. Yale: Advisory Panel; Self; Medtronic, Abbott. Speaker's Bureau; Self; Abbott. Advisory Panel; Self; AstraZeneca. Speaker's Bureau; Self; AstraZeneca. Advisory Panel; Self; Janssen Pharmaceuticals, Inc.. Speaker's Bureau; Self; Janssen Pharmaceuticals, Inc.. Advisory Panel; Self; Novo Nordisk Inc.. Speaker's Bureau; Self; Novo Nordisk Inc.. Advisory Panel; Self; Sanofi. Speaker's Bureau; Self; Sanofi. Advisory Panel; Self; Eli Lilly and Company. Speaker's Bureau; Self; Eli Lilly and Company. Advisory Panel; Self; Boehringer Ingelheim Pharmaceuticals, Inc.. Speaker's Bureau; Self; Boehringer Ingelheim Pharmaceuticals, Inc.. Advisory Panel; Self; Takeda Canada Inc.. Speaker's Bureau; Self; Takeda Canada Inc.. Advisory Panel; Self; Merck & Co., Inc.. Speaker's Bureau; Self; Merck & Co., Inc., Bayer AG. Research Support; Self; Mylan, AstraZeneca, Bayer AG, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Sanofi. J. Rutkowski: None. A. Bossy: Other Relationship; Self; Insulet Corporation, Medtronic. E. Pytka: Consultant; Self; Animas Corporation. H.T. Nguyen: None. L. Legault: Advisory Panel; Self; Insulet Corporation. Research Support; Self; Merck & Co., Inc., Sanofi. Advisory Panel; Self; Medtronic. Other Relationship; Self; Eli Lilly and Company.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,002 | 0,003 |
| Méta-épidémiologie (sens strict) | 0,002 | 0,001 |
| Méta-épidémiologie (sens large) | 0,006 | 0,003 |
| Bibliométrie | 0,001 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,001 |
| Communication savante | 0,002 | 0,002 |
| Science ouverte | 0,001 | 0,001 |
| Intégrité de la recherche | 0,002 | 0,003 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,007 | 0,001 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».