Health Technology/clinical-trials

Phase IV Trial Evaluates Digital Insulin Assistant for Type 1 Diabetes Management — French Study Tests Time-in-Range Outcomes

247 Health News Editorial

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11 Apr 2026

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4 min read

·clinical-trials

French 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. 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. 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. 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. 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. 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. 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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