1105-P: Impact of Switching from Twice-Daily Basal Insulin (BI) to Once-Daily Insulin Glargine 300 U/mL (Gla-300) in Patients with Type 1 Diabetes (T1DM): Phase 4 Optimize Study
Bibliographic record
Abstract
The 28-week, prospective, multicenter, open-label OPTIMIZE study, conducted in Belgium (presented at ADA 2018) and Canada, evaluated treatment optimization with once-daily (OD) Gla-300 in combination with a prandial insulin analog in adults with T1DM previously uncontrolled (HbA1c 8-10%) on twice-daily (BID) BI as part of basal-bolus therapy. The intent-to-treat and safety populations comprised 94 patients (53.2% women; 51.1% from Belgium); mean (SD) age 49.4 (13.1) years and BMI 27.8 (4.7) kg/m². Prior to the study, 45.7% received insulin glargine 100 U/mL and 52.1% insulin detemir. There was a statistically significant reduction in HbA1c from baseline to month 6 (p<0.0001; Table). A statistically significant increase in BI dose (p=0.032) was observed, but there were no significant changes in prandial insulin dose. Hypoglycemic event rates did not significantly change (Table). Statistically significant improvements were seen in the Diabetes Treatment Satisfaction Questionnaire total and perceived hyperglycemia scores, and patient satisfaction score for number of injections (p<0.0001). In this clinically challenging population, better overall treatment satisfaction and improvement in HbA1c, without increase in the rate of hypoglycemia, was achieved on switching from BID to OD Gla-300 plus prandial insulin. Disclosure C. Mathieu: Advisory Panel; Self; Boehringer Ingelheim International GmbH, Eli Lilly and Company, Merck & Co., Inc., Novo Nordisk A/S, Roche Diabetes Care, Sanofi. Speaker's Bureau; Self; AstraZeneca, Novartis AG, Novo Nordisk A/S, Sanofi. P. Stella: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. J. Bruhwyler: Other Relationship; Self; Sanofi. K.C. Alexandre: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. Funding Sanofi (EudraCT 2015-001186-46)
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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 | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.005 | 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".