848-P: Efficacy and Safety of GlucoLo Plus in Type 2 Diabetes Management
Bibliographic record
Abstract
Background and Aims: Diabetes is globally increasing in prevalence and patients are constantly on the lookout for Complementary and Alternative Medicines (CAM) that are safe and efficacious including biologically-based practices such as vitamins and dietary supplements. Methods: This double-blind randomised placebo-controlled trial evaluated the effects of daily GlucoLo Plus, a newly formulated biologically-based CAM for diabetes type 2 management. The primary outcome was to evaluate the effect of GlucoLo Plus on HbA1c and the secondary outcomes were to assess its effect on fasting glycemia, lipid profile, weight and assess its safety profile. Results: Of 64 individuals assessed for eligibility, 60 (mean HbA1c 6.98% [52.8 mmol/mol], mean age 67.3 years [SD 9.5], 26 [43%] women, mean diabetes duration 3.2 years, and mean body mass index 27.9 kg/m2) were randomly assigned to GlucoLo Plus (n=32 [53%]) , or placebo (n=28 [47%]) . At 12 weeks, GlucoLo Plus decreased HBA1c by 0.843% (P=0.0121) while placebo reduced it by 0.132% (p = 0.5951) . GlucoLo Plus was also associated with non-significant reduction in fasting glycemia, total cholesterol, triglyceride, and LDL-cholesterol. GlucoLo Plus arm had a mean 1.84 lbs weight loss while the placebo arm had a 0.21 lbs weight gain. The most frequent adverse events with GlucoLo Plus were mild and transient gastrointestinal events including nausea (9.3% vs. 3.5%) and dyspepsia (15.6% vs. 10.7%) . Conclusion: GlucoLo Plus significantly lowered HbA1c and had positive effect on bodyweight, fasting glycemia, LDL-cholesterol and had a minimal side effect profile. These results suggest that GlucoLo Plus could be an alternative and adjunct to type 2 diabetes management in people who are reluctant to initiate or add new antidiabetic agents. Disclosure A.R.Zarruk: Advisory Panel; Amgen Canada, AstraZeneca, Bausch Health, Canada, Boehringer Ingelheim International GmbH, Eisai Inc., Eli Lilly and Company, HLS Therapeutics Inc., Novo Nordisk Canada Inc., Sanofi, Takeda Canada, Valeant Pharmaceuticals, Other Relationship; Groupe Nature Pharma, Research Support; Abbott Diabetes, Novo Nordisk Canada Inc., Orimed Pharma, Speaker's Bureau; Abbott, Abbott Diabetes, Amgen Canada, AstraZeneca, Bausch Health, Canada, Boehringer Ingelheim International GmbH, Eli Lilly and Company, HLS Therapeutics Inc., Janssen Pharmaceuticals, Inc., Mylan N.V., Novo Nordisk Canada Inc., Orimex Pharma, Sanofi, Takeda Canada, Valeant Pharmaceuticals, Viatris Inc. Funding Groupe Nature Pharma
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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 | 0.002 |
| 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 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.008 | 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".