Impact of Switching from Twice-Daily Basal Insulin to Once-Daily Insulin Glargine 300 U/mL (Gla-300) in Patients with Type 1 Diabetes (T1DM)—Phase 4 OPTIMIZE Study, Belgian Cohort
Bibliographic record
Abstract
The 28-week, prospective, multicenter, open-label OPTIMIZE study, conducted in Belgium and Canada, evaluated treatment optimization with once-daily (OD) Gla-300 in combination with a prandial rapid-acting insulin analog in adults with T1DM previously uncontrolled (HbA1c 8-10%) on twice-daily (BID) basal insulin as part of basal-bolus therapy. The intent-to-treat (ITT) and safety populations of the Belgian cohort comprised 48 patients (52.1% women); mean (SD) age 51.7 (12.8) years and mean (SD) body mass index 28.2 (4.9) kg/m². Prior to the study, 37.5% were on insulin glargine 100 U/mL and 62.5% were on insulin detemir. There was a statistically significant reduction in HbA1c from baseline to month 6 (primary endpoint, p<0.0001). No significant changes were observed in basal or prandial insulin dose, or in total or nocturnal hypoglycemic event rates. Statistically significant improvements were seen in the Diabetes Treatment Satisfaction Questionnaire (DTSQ) total and perceived hyperglycemia scores (p<0.05) (Table), and in the patient satisfaction score for number of injections (p=0.004). Switching from a BID basal insulin analog to OD Gla-300 in this challenging T1DM population was associated with a statistically significant improvement in HbA1c levels and better overall treatment satisfaction. Disclosure C. Mathieu: Research Support; Self; Novo Nordisk A/S. Advisory Panel; Self; Novo Nordisk A/S. Speaker's Bureau; Self; Novo Nordisk A/S. Research Support; Self; Sanofi. Speaker's Bureau; Self; Sanofi. Advisory Panel; Self; Sanofi. Research Support; Self; Merck Sharp & Dohme Corp.. Speaker's Bureau; Self; Merck Sharp & Dohme Corp.. Advisory Panel; Self; Merck Sharp & Dohme Corp.. Research Support; Self; Eli Lilly and Company. Speaker's Bureau; Self; Eli Lilly and Company. Advisory Panel; Self; Eli Lilly and Company. Research Support; Self; Novartis AG. Speaker's Bureau; Self; Novartis AG. Advisory Panel; Self; Novartis AG, Bristol-Myers Squibb Company. Speaker's Bureau; Self; AstraZeneca. Advisory Panel; Self; AstraZeneca, Pfizer Inc., Janssen Pharmaceuticals, Inc., Boehringer Ingelheim GmbH. Speaker's Bureau; Self; Boehringer Ingelheim GmbH. Advisory Panel; Self; Hanmi Pharmaceutical. Research Support; Self; Roche Diagnostics Corporation. Advisory Panel; Self; Roche Diagnostics Corporation. Research Support; Self; Medtronic. Advisory Panel; Self; Medtronic, MannKind Corporation. Research Support; Self; Intrexon. Advisory Panel; Self; Intrexon, Dianax, UCB, Inc.. Research Support; Self; Abbott. P. Stella: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. J. Bruhwyler: Other Relationship; Self; Sanofi. K. Alexandre: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi.
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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 | 0.001 |
| 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 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 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 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".