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NCT04509362
An 8-Day Initiation of Advanced Hybrid Closed Loop System In Children and Adolescents
trial testing Advanced Hybrid Closed Loop System in Type 1 Diabetes in 34 participants. Completed in 1 September 2021.
31 May 2021
Quick facts
| Lead sponsor | Sidra Medicine |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 34 |
| Start date | 1 October 2020 |
| Primary completion | 31 May 2021 |
| Estimated completion | 1 September 2021 |
| Sites | 1 location across Qatar |
Drugs / interventions tested
- Advanced Hybrid Closed Loop System
Conditions studied
- Type 1 Diabetes — all drugs for Type 1 Diabetes →
Sponsor
Sidra Medicine
Who can join
Adults 7 to 18, any sex, with Type 1 Diabetes. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
One of the available Hybrid closed loop system is MiniMed 670G (Medtronic Diabetes, Northridge, CA, USA), which is indicated for children above 7 years old, adolescents and adults with Type 1 Diabetes. Several studies have shown improved HbA1c, time in target range, and SG variability in children, adolescents and adults with Type 1 Diabetes, where participants were experienced with using CSII therapy, assuming that the success of HCL systems depend on prior use of pump therapy. A recent study, published by diabetes team from Sidra Medicine, Doha has showed that children and adolescents with Type 1 Diabetes on MDI therapy can successfully initiate the HCL system, using a concise structured 10-day protocol, achieving better outcomes than in previous studies, where participants had previous experience with diabetes related technology and longer initiation process. The AHCL system, Minimed 780G is CE-marked includes additional functionality aiming to provide further protections from highs. The user can choose the algorithm to target a glucose level of 100 or 120 mg/dL. Like for the MiniMed 670G HCL system, users can also choose the algorithm to temporarily target a glucose value of 150 mg/dL. In addition, the AHCL system has the ability to administer correction bolus automatically, targeting 120 mg/dL. The AHCL algorithm was evaluated with a model-based algorithm design platform incorporating a virtual patient simulator, where additional changes were made (lower target ranges and automated correction boluses ( )). A recent study including 12 patients with type 1 diabetes on AHCL system, has shown no episodes of hypoglycemia or diabetic ketoacidosis, while maintaining 99% time spent in closed loop and high time in ra1\]\\nge ( ). AHCL decreased Auto Mode exits and alerts, and improves glycaemia without compromising safety, despite multiple food and exercise challenges ( ). Sidra Medicine is the only center for childhood diabetes in Qatar. Around 80% of type 1 diabetes patients are using a device (insulin pump/glucose sensor) and around 45% are using sensor-augmented pump (SAP)/HCL systems.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04509362
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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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 NCT04509362 (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 Sidra Medicine
- Last refreshed: 28 September 2021
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/NCT04509362.
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