Low-dose empagliflozin as adjunct to hybrid closed-loop insulin therapy in sub-optimally controlled adults with type 1 diabetes: a randomized crossover controlled trial
Bibliographic record
Abstract
Objective: To assess whether low doses of empagliflozin as adjunct to hybrid closed-loop therapy improve glycemia compared to placebo in adults with type 1 diabetes who are not able to achieve targets with the system alone. Research Design and Methods: A double-blind, crossover, randomized controlled trial was performed in sub-optimally controlled (HbA1c 7.0-10.5%) adults who were not able to achieve a target time-in-range (3.9-10.0 mmol/L) ≥ 70% after 14 days of hybrid closed-loop therapy. Three 14-day interventions were performed with placebo, empagliflozin 2.5 mg, or empagliflozin 5 mg, as adjunct to the McGill Artificial Pancreas. Participants were assigned in a 1:1:1:1:1:1 ratio with blocked randomization. The primary outcome was time-in-range (3.9-10.0 mmol/L). Analysis was by intention to treat and a p-value of less than 0.05 was regarded as significant. This trial is registered, NCT04450563. Results: 24 participants completed the study (50% male, age 33 ± 14 yrs, HbA1c 8.1 ± 0.5%). The time-in-range was 59.0 ± 9.0% for placebo, 71.6 ± 9.7% for empagliflozin 2.5 mg, and 70.2 ± 8.0% for empagliflozin 5 mg (p <0.0001 between empagliflozin 2.5 mg and placebo, and empagliflozin 5 mg and placebo). Mean daily capillary ketone levels were not different between arms. There were no serious adverse events, diabetic ketoacidosis, or severe hypoglycemia in any intervention. Conclusions: Empagliflozin 2.5 mg and 5 mg increased time-in-range on hybrid closed-loop therapy by 11–13 percentage points compared to placebo, in those who otherwise were unable to attain glycemic targets. Future studies are required to assess long-term efficacy and safety.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
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 | 0.003 | 0.003 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.005 | 0.003 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.007 | 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".