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The Steno Opti-Bolus-Timing Studies

Launched by STENO DIABETES CENTER COPENHAGEN · Jun 13, 2025

Trial Information

Current as of July 09, 2025

Not yet recruiting

Keywords

Aid System Bolus Timing Glycemic Index

ClinConnect Summary

The Steno Opti-Bolus-Timing Studies is a research project aimed at understanding how the timing of insulin doses affects blood sugar levels in people with Type 1 Diabetes (T1D). Specifically, the study is looking at whether giving insulin 15 minutes before meals (breakfast or lunch) leads to better blood sugar control compared to giving it at the start of the meal or 30 minutes after. Researchers will also explore how the type of carbohydrates in the meal—whether they are quickly absorbed or slowly absorbed—might influence blood sugar levels after eating.

To be eligible for the study, participants need to be between 18 and 70 years old, have had Type 1 Diabetes for at least three years, and have been using a specific insulin pump (MiniMed 780G) for a minimum of three months. Participants will attend the research site for up to six days over three months to try different timing strategies while having controlled meals. Throughout the study, their blood sugar will be monitored for several hours after eating. It's important to note that some people may not qualify due to certain health conditions or medications. This study aims to help improve meal-time insulin dosing strategies for better blood sugar management in people with T1D.

Gender

ALL

Eligibility criteria

  • Inclusion criteria:
  • Type 1 diabetes ≥ 3 years Age 18-70 years User of the MiniMed 780G for at least 3 months Use of Novorapid insulin in the pump (for a minimum of two weeks) TIR \> 70% for minimum of 14 days Use carbohydrate counting and bolus calculation Uploads insulin pump and CGM data to the Carelink Personal database Pump settings: carbohydrate ratio (300-500 rule), active insulin time of ≤ 3 hours and smartguard target glucose of 5.5 or 6.1 mmol/L
  • Exclusion criteria:
  • Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 4 weeks prior to study start Diagnosed with gastroparesis Females who are pregnant, breast-feeding Food allergies related to standardized meals Alcohol or drug abuse Inability to understand the individual information and to give informed consent.
  • Current participation in another clinical trial that, in the judgment of the principal investigator, will compromise the study results

About Steno Diabetes Center Copenhagen

Steno Diabetes Center Copenhagen is a leading clinical research facility dedicated to advancing the understanding and treatment of diabetes and its complications. As a prominent sponsor of clinical trials, the center focuses on innovative research that bridges clinical practice and scientific inquiry, fostering collaborations with healthcare professionals, researchers, and patients. Committed to improving patient outcomes, Steno Diabetes Center Copenhagen emphasizes evidence-based approaches and cutting-edge methodologies to enhance diabetes management and care, ultimately contributing to the global fight against this chronic disease.

Locations

Herlev, , Denmark

Patients applied

0 patients applied

Trial Officials

Kirsten Nørgaard, Professor

Principal Investigator

Steno Diabetes Center Copenhagen Clinical Translational Research, Diabetes Technology

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported