977-P: Alleviating Carbohydrate Counting with a FiASP-and-Pramlintide Artificial Pancreas: A Randomized Pilot Study
Bibliographic record
Abstract
Objective: The aim of this pilot study was to assess if a FiASP-and-pramlintide artificial pancreas (AP) could alleviate the need for CHO counting by using a simple meal announcement system (pressing a button, no CHO counting) without degrading glycemic control. Methods: We conducted a 24-hour inpatient, randomized, crossover, non-inferiority, pilot study to compare (i) FiASP AP with full CHO counting (FCC) and CHO-matched boluses with (ii) FiASP-and-pramlintide AP with simple meal announcement (SMA). Pramlintide and FiASP were delivered in a basal-bolus manner using a fixed ratio (1U: 10µg). Results: Seven participants (age 26.2±16, HbA1c 8.4±0.8%) were included in the analysis. The time in range (3.9-10 mmol/L) was 85.7% (IQR: [72-93]) in the FCC arm and 87.3% [75-95] in the SMA arm (p=0.21). Time spent >10mmol/L did not differ between interventions (FCC: 11.4% [0.9-22], SMA: 10.1% [3.1-25], p=0.38). Time <3.9mmol/L was lower in the SMA arm (2.1% vs. 4.1%, p=0.02). One participant experienced persistent GI symptoms in the SMA arm. Conclusions: The FiASP-and-pramlintide SMA system has the potential of reducing the burden of CHO counting without degrading glucose control. Outpatient studies are warranted. Disclosure M. Tsoukas: Advisory Panel; Self; Eli Lilly and Company, Novo Nordisk Inc. Speaker’s Bureau; Self; Boehringer Ingelheim (Canada) Ltd., Janssen Scientific Affairs, LLC. E. Palisaitis: None. J. Rutkowski: None. J.E. von Oettingen: None. L. Legault: Advisory Panel; Self; Dexcom, Inc., Lilly Diabetes. Research Support; Self; AstraZeneca K.K., Merck & Co., Inc., Sanofi-Aventis. Other Relationship; Self; Lilly Diabetes. J. Yale: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim (Canada) Ltd., Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk A/S, Sanofi. Board Member; Self; Diagnos. Research Support; Self; Bayer Inc., Novo Nordisk A/S, Sanofi. Speaker’s Bureau; Self; Abbott, AstraZeneca, Boehringer Ingelheim (Canada) Ltd., Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Medtronic, Novo Nordisk A/S, Sanofi. A. Haidar: Consultant; Self; Eli Lilly and Company. Research Support; Self; Dexcom, Inc., Eli Lilly and Company. Funding JDRF (2-SRA-2018-654-M-B)
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.002 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.009 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".