Comparison of SmartGuard vs Temp Target in Patients With Type 1 Diabetes Users of Advanced Hybrid Closed Loop System (AHCL) in Anaerobic Physical Activity. Clinical, Randomized, Crossover Trial.

Launched by HOSPITAL UNIVERSITARIO SAN IGNACIO · Dec 6, 2024

Keywords

ClinConnect Summary

This clinical trial is comparing two different settings on an advanced diabetes management system for people with Type 1 Diabetes (T1D) during exercise. Specifically, it looks at how the "SmartGuard" mode and a "Temp Target" mode affect blood sugar levels during anaerobic physical activities, like strength training. Participants will be grouped randomly to try both modes, helping researchers understand which one helps better in managing blood sugar during exercise.

To be eligible for this study, participants must have been diagnosed with Type 1 Diabetes for at least a year, have been using the Minimed 780G system with continuous glucose monitoring for the last three months, and be physically active, meaning they’ve exercised at least once a week in the past six months. During the trial, participants will engage in supervised exercise sessions, where their blood sugar will be checked before and after workouts to ensure it's in a safe range. Overall, this study aims to improve diabetes management for those who are active, helping them to exercise safely and effectively.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Diagnosis of type 1 diabetes ≥ 1 year ago
• • AHCL users (Minimed 780G) with integrated continuous glucose monitoring
• • Use of the device for at least the last 3 months
• • Physically active (PA≥1): At least one weekly physical exercise session in the last 6 months.
• Exclusion Criteria:
• • Pregnancy
• • Physical or mental inability to exercise
• • Contraindication to performing Valsalva maneuvers
• • History of osteoarticular disease that prevents exercise
• • History of tendinopathies that cause pain or limitation
• • History of coronary artery disease
• • Diabetic ketoacidosis or severe hypoglycemia in the last month
• • Evidence of autonomic failure (Unnoticed hypoglycemia given by Clarke 3 or more points Appendix 1) I am concerned because now that I am on a pump, this indication is common as support for the insulin pump.
• • Use of beta-blockers or glucocorticoids
• • Peripheral arterial disease
• • Severe proliferative diabetic retinopathy or non-proliferative diabetic retinopathy
• • Severe peripheral neuropathy
• • Stage 5 chronic kidney disease on renal replacement therapy