Peer-reviewed article
Pre-Ramadan time-below-range stratifies the simulated pump basal-rate dose-response during Ramadan fasting: a five-policy paired virtual-patient study.
Banjar A ·
Summary
Written by AI, not yet AICS's view · claude-haiku-4-5-20251001This is a technical study on insulin pump management for children and adults with diabetes during Ramadan fasting, using computer simulations. It examines how different levels of basal insulin reduction affect blood glucose control and hypoglycemia risk. The findings suggest that a 90% basal rate reduction offers the best balance between preventing low blood sugar and maintaining glucose control. The study is based entirely on virtual patient simulations and has not been tested in real clinical settings.
Key points
- Virtual simulations showed that 90% basal rate reduction reduced hypoglycemia risk while minimizing loss of time in glucose range
- Deeper basal reductions (70-60%) caused severe hyperglycemia to increase from 2.9% to 14.8% of the time
- Pre-Ramadan blood glucose patterns helped predict how individual patients would respond to different basal rate policies
- Results are from computer simulations only and require prospective clinical validation before clinical use
- Safety-first protocols reduced hypoglycemia but came with a trade-off of 5.2-point loss in time within target glucose range
Limitations
This study uses only computer-simulated virtual patients and does not test actual children or adults with diabetes. The findings explicitly require prospective, real-world validation with continuous glucose monitoring before any clinical application.
Abstract
Background Pump basal-rate reduction during Ramadan may prevent hypoglycemia but can increase hyperglycemia. Its dose-response relation and phenotype-dependent trade-off remain uncertain. Methods Thirty UVA/Padova virtual patients (10 children, 10 adolescents, 10 adults) underwent paired 30-day Ramadan conditions delivering 100%, 90%, 80%, 70%, or 60% of the pump steady-state basal rate. The primary complete-case analysis included 29 virtual patients. Outcomes were time in range (TIR), time below range (TBR), time above range (TAR, including TAR > 250 and TAR > 300), and rescue corrections. Paired permutation tests and bootstrap intervals quantified effects. Robustness and revision analyses used three sensor seeds, three seeded meal/timing scenarios with a held-out evaluation, a reactive-correction sensitivity analysis, a time-of-day decomposition, terminal-event reporting, and a negative-control (sham) test of the pre-Ramadan marker. Results Mean TIR was 81.7%, 79.9%, 73.9%, 65.3%, and 56.0% at 100%, 90%, 80%, 70%, and 60%, respectively (P <0.001). Compared with 100%, 90% basal reduced TBR by 1.6 percentage points (95% CI -2.1 to -1.2) while changing TIR by -1.8 points (95% CI -3.7 to -0.3; Holm-adjusted P = 0.031). Severe hyperglycemia rose steeply with deeper reduction (TAR>250: 2.9% at 100% to 14.8% at 60%). Enabling realistic reactive corrections raised TIR at the deepest policies but preserved the same policy ordering. Pre-Ramadan TBR stratified the TIR response across reduced policies (omnibus patient-blocked permutation P = 0.023), with the strongest gradients at 70% and 60% basal; a negative-control analysis showed this signal was not specific to TBR but reflected a broader baseline-glycemia pattern. In a held-out scenario, a revised safety-first selection rule improved hypoglycemia-target attainment (39% to 79%) and reduced TBR by 2.9 points but incurred a 5.2-point TIR cost, demonstrating that prioritizing fasting safety involves a glycemic trade-off. Conclusion Ramadan pump basal-rate reduction should be treated not as a uniform percentage change but as a phenotype- and context-dependent trade-off. Among the reduced policies, 90% basal produced the smallest TIR loss while lowering hypoglycemia; pre-Ramadan TBR was an exploratory candidate stratifier; and meal-size associations differed by policy. These mechanistic findings apply to simulated pump basal-rate modulation and require prospective, CGM-anchored validation before any clinical use.