Glycemic control after 6 days of insulin pump reservoir use in type 1 diabetes: Results of double‐blind and open‐label cross‐over trials of insulin lispro and insulin aspart 1型糖尿病患者连续使用胰岛素泵6天后的血糖控制情况：赖脯胰岛素与门冬胰岛素的双盲、开放标签、交叉试验
Bibliographic record
Abstract
BACKGROUND: The objective of the current study was to assess mean self-monitored blood glucose (SMBG), on day 6 of 6 days of continuous reservoir wear (6D), with insulin lispro (Lis) or insulin aspart (Asp). METHODS: Two 24-week, randomized trials were conducted in subjects with type 1 diabetes treated by continuous subcutaneous insulin infusion (CSII) for ≥6 months, with a mean total daily insulin dose capable of supporting 6 days of in-reservoir use. Study 1 had an open-label, six-sequence, three-treatment, three-period, cross-over design. Study 2 had a double-blind, two-sequence, two-treatment, two-period, cross-over design. The primary efficacy measure was the mean of Day 6, seven-point SMBG profiles for insulin lispro 6D (Lis6D) and insulin aspart 6D (Asp6D) treatment periods. Safety measures were also assessed. RESULTS: Lis did not achieve noninferiority (SMBG; margin = 0.6 mmol/L [10.8 mg/dL]) to Asp on Day 6 of reservoir wear in either Study (least-squares mean difference: Study 1 = 0.48 mmol/L [8.64 mg/dL]; 95% confidence interval [CI] [0.20, 0.76], Study 2 = 0.36 mmol/L [6.49 mg/dL]; 95% CI [0.06, 0.66]). Noninferiority was demonstrated for overall daily mean of SMBG values over days 1 to 6 of reservoir use during each treatment period. In the Lis treatment period, subjects reported a lower documented and total hypoglycemia rate per 30 days and a higher rate of non-explained hyperglycemia than in the Asp treatment period. CONCLUSION: While the mean blood glucose on Day 6 of Lis6D did not meet non-inferiority, the overall daily mean blood glucose was not different, with a decreased rate of hypoglycemia with Lis.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.010 | 0.009 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.000 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
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 teacher head, 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".