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NCT05134025: SMART
The SMART A Exercise Study :''The SMART Study''
NA trial testing Pump settings in Type 1 Diabetes in 10 participants. Completed in 23 August 2022.
23 August 2022
Quick facts
| Lead sponsor | Steno Diabetes Center Copenhagen |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 14 September 2021 |
| Primary completion | 23 August 2022 |
| Estimated completion | 23 August 2022 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- Pump settings
Conditions studied
- Type 1 Diabetes — all drugs for Type 1 Diabetes →
Sponsor
Steno Diabetes Center Copenhagen — full company profile →
Who can join
Adults 18 to 75, any sex, with Type 1 Diabetes. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Despite the promising data emanating from trials investigating the effectiveness of advanced hybrid closed loop (AHCL) insulin delivery systems in managing glycaemia in those with type 1 diabetes (T1D), we currently know little about their efficacy in optimising glycaemia when physical activity is factored into the equation. With the introduction of new AHCL systems that have novel technological features, we are left with important questions of how to optimise their use around physical exercise to not only minimise dysglycaemia, but also encourage individuals with T1D to lead a physically active lifestyle for the associated wider health benefits. This will be a three-period, randomised, cross-over study with a single-hormone (insulin) AHCL system that compares the efficacy of three insulin management strategies: (i) unannounced exercise and a full dose of meal-time insulin 90-minutes prior to commencement, (ii) a 25% reduced dose of meal-time insulin with exercise announcement 90-minutes prior to commencement and (iii) a 25% dose reduction in meal-time insulin with exercise announcement 45-minutes prior to commencement, in optimising TIR around dynamic physical exercise in adults with T1D.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Automated Insulin Delivery Around Exercise in Adults with Type 1 Diabetes: A Pilot Randomized Controlled Study.
McCarthy OM, Christensen MB, Kristensen KB, Schmidt S, et al · · 2023 · cited 13× · PMID 37053529 · DOI 10.1089/dia.2023.0009 -
Metabolic and physiological responses to graded exercise testing in individuals with type 1 diabetes using insulin pump therapy.
McCarthy OM, Kristensen KB, Christensen MB, Schmidt S, et al · · 2023 · cited 5× · PMID 36482870 · DOI 10.1111/dom.14938
Verify or expand the search:
- PubMed search for NCT05134025
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Type 1 Diabetes
Currently open trials in the same condition.
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- NCT07287943 — To Study the Efficacy and Safety of Medtronic 780G Insulin Pump in People With Gastroparesis and Type 1 Diabetes. · NA · recruiting
Other Steno Diabetes Center Copenhagen trials
Trials by the same sponsor.
- NCT07485075 — Digital Support for Reducing Salt Intake Among Patients With Diabetic Kidney Disease: Protocol for a Controlled Clinical · NA · recruiting
- NCT07427251 — The Postprandial Hypo-Avoid Study · Phase 4 · not yet recruiting
- NCT06954090 — Urinary Proteomics to Guide Early Intervention to Prevent Complications in Type 2 Diabetes - a Feasibility Study · Phase 4 · enrolling by invitation
- NCT06832059 — Precision Nutrition Versus Standard Dietary Care: Continuous Glucose Monitoring as a Tool for Guided Nutrition Care in T · NA · recruiting
- NCT07377266 — The Impact of Changing to a New Child- and Family-centered Outpatient Diabetes Clinic Focusing on Early Involvement of t · NA · enrolling by invitation
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 NCT05134025 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Steno Diabetes Center Copenhagen
- Last refreshed: 3 November 2022
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/NCT05134025.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing