Phase IV Trial Evaluates Digital Insulin Assistant for Type 1 Diabetes Management — French Study Tests Time-in-Range Outcomes
247 Health News Editorial
·11 Apr 2026
·4 min read
·clinical-trialsFrench randomised controlled trial evaluates Hedia Diabetes Assistant app for improving time-in-range in adults with type 1 diabetes and suboptimal glycaemic control. Results expected 2026.
Originally reported by ClinicalTrials.gov
References
- 1.Australian Government Department of Health. (2021). Australian National Diabetes Strategy 2021-2030. Department of Health. https://www.health.gov.au/resources/publications/australian-national-diabetes-strategy-2021-2030
- 2.Battelino, T., Danne, T., Bergenstal, R. M., Amiel, S. A., Beck, R., Biester, T., Bosi, E., Buckingham, B. A., Cefalu, W. T., Close, K. L., Cobelli, C., Dassau, E., DeVries, J. H., Donaghue, K. C., Dovc, K., Doyle, F. J., Garg, S., Grunberger, G., Heller, S., ... Phillip, M. (2019). Clinical targets for continuous glucose monitoring data interpretation: recommendations from the international consensus on time in range. Diabetes Care, 42(8), 1593-1603. https://doi.org/10.2337/dci19-0028
- 3.Foster, N. C., Beck, R. W., Miller, K. M., Clements, M. A., Rickels, M. R., DiMeglio, L. A., Maahs, D. M., Tamborlane, W. V., Bergenstal, R., Smith, E., Olson, B. A., & Garg, S. K. (2019). State of type 1 diabetes management and outcomes from the T1D Exchange in 2016-2018. Diabetes Technology & Therapeutics, 21(2), 66-72. https://doi.org/10.1089/dia.2018.0384
- 4.Hedia ApS. (2024). The Effect of Hedia Diabetes Assistant on TiMe-in-range in People With Type 1 Diabetes and Sub-Optimal Glycemic Control in France - A Randomised Controlled Trial. ClinicalTrials.gov. NCT06819306. https://clinicaltrials.gov/study/NCT06819306
- 5.Heinemann, L., Freckmann, G., Ehrmann, D., Faber-Heinemann, G., Guerra, S., Waldenmaier, D., & Heller, S. (2021). Real-time continuous glucose monitoring in adults with type 1 diabetes and impaired hypoglycaemia awareness or severe hypoglycaemia treated with multiple daily insulin injections. Diabetes Care, 44(11), 2572-2580. https://doi.org/10.2337/dc20-1460
- 6.Schmidt, S., Meldgaard, T., Serifovski, N., Storm, C., Christensen, T. M., Gade-Rasmussen, B., & Nørgaard, K. (2019). Use of an automated bolus calculator in MDI-treated type 1 diabetes: the BolusCal Study, a randomized controlled pilot study. Diabetes Care, 42(5), 902-907. https://doi.org/10.2337/dc18-1474
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247 Health News Editorial
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