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NCT05736263: SAFE-T1D
Exercise-induced Glycemic Variations and Hybrid Closed-loop Systems
NA trial testing Moderate intensity exercise in Type 1 Diabetes in 50 participants. Status unknown.
22 December 2024
Quick facts
| Lead sponsor | University of Roma La Sapienza |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | other |
| Enrollment | 50 |
| Start date | 31 March 2023 |
| Primary completion | 22 December 2024 |
| Estimated completion | 22 December 2024 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Moderate intensity exercise
- High intensity interval exercise
- Combined exercise
- Resistance exercise
Conditions studied
- Type 1 Diabetes — all drugs for Type 1 Diabetes →
- Exercise — all drugs for Exercise →
Sponsor
University of Roma La Sapienza
Who can join
Adults 18 to 65, any sex, with Type 1 Diabetes or Exercise. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Type 1 diabetes is characterized by high risk of hypoglycemia and associated fear of hypoglycemia. Hypoglycemia risk is higher during and after physical activity, especially aerobic activity of long duration. Fear of hypoglycemia can result in avoidance of exercise or overcompensatory eating, both related to worse metabolic control and increased cardiometabolic risk. Hybrid closed-loop (HCL)systems have significantly improved risk of hypoglycemia. They also offer the possibility to set a temporary target for physical activity, further reducing the risk of hypoglycemia during physical activity. Although temporary target seems to work rather well with moderate-intensity aerobic exercise, little data is available for other types of exercise, like resistance exercise, high-intensity interval exercise, combined modalities of exercise, in which the temporary target seems to perform less well. The present study aims to test the performance of current HCL systems under different exercise conditions and evaluate the relationship between different exercise variables (recorded during exercise), physical activity variables (measured by accelerometry) and glycemic variations in HCL system users.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05736263
- Europe PMC full search
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05736263 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Roma La Sapienza
- Last refreshed: 25 April 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05736263.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing