Who is sponsoring NCT04269668?

NCT04269668 is sponsored by Rabin Medical Center.

What drugs are being tested in NCT04269668?

Interventions in NCT04269668: Medtronic Minimed 670G 3.0 HCL, Medtronic Minimed 670G 4.0 AHCL.

What condition does NCT04269668 study?

NCT04269668 studies Diabetes Mellitus, Type 1.

Is NCT04269668 still recruiting?

NCT04269668 is currently completed. Last updated 22 February 2022.

Last reviewed 2022-02-22 · How we verify

NCT04269668

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

An Open-label, Two-center, Randomized, Cross-over Study to Evaluate the Safety and Efficacy of Glycemic Control Using Hybrid-closed Loop vs. Advanced Hybrid Closed-loop in Young Subjects With Type 1 Diabetes

Completed NA Last updated 22 February 2022

What this trial tests

NA trial testing Medtronic Minimed 670G 3.0 HCL in Diabetes Mellitus, Type 1 in 28 participants. Completed in 20 March 2021.

Timeline

19 July 2020

Primary endpoint
20 February 2021

20 March 2021

Quick facts

Lead sponsor	Rabin Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	28
Start date	19 July 2020
Primary completion	20 February 2021
Estimated completion	20 March 2021
Sites	2 locations across Israel, Germany

Drugs / interventions tested

Medtronic Minimed 670G 3.0 HCL
Medtronic Minimed 670G 4.0 AHCL

Conditions studied

Diabetes Mellitus, Type 1 — all drugs for Diabetes Mellitus, Type 1 →

Sponsor

Rabin Medical Center

Who can join

Adults 7 to 14, any sex, with Diabetes Mellitus, Type 1. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Closed-loop systems are becoming an integral part of diabetes management. These systems were uniformly proven to improve glycemic control, reduce hyperglycemia and hypoglycemia while modestly reducing HbA1c levels and improving quality of life. While overnight control is close to optimal under closed loop control, postprandial hyperglycemia during daytime remains a challenge. The advanced hybrid closed loop system was designed with an improved auto-basal control and additional auto-bolus module that delivers correction boluses automatically. In addition, this system was developed to improve user experience by significantly reducing the amount of alarms and exits from Auto Mode. Therefore, this system might have an advance in treating hyperglycemia over the hybrid closed loop that controls glucose levels by modulation of insulin basal rate only. Therefore, we propose the current study that will compare 6 weeks glycemic control using hybrid closed loop versus advanced hybrid closed loop that add correction boluses among young children and adolescents. The objective of this study is to evaluate and compare the safety and efficacy of 6 weeks glucose control using Hybrid Closed Loop (HCL-670G) compared to Advanced Hybrid Closed Loop System (AHCL- 670G) in young subjects with sub-optimally controlled type 1 diabetes. A total of 28 subjects (age 7-14 years) will be enrolled at two investigational centers. At the end of the cross-over study participants will be offered with an extension period, during which they will be offered to use their preferred closed-loop system for another 3 months

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:

Other recruiting trials for Diabetes Mellitus, Type 1

Currently open trials in the same condition.

NCT07325461 — Feasibility Study of Extended Wear Insulin Infusion Set Options During Home Use in People With Type 1 Diabetes · NA · recruiting
NCT07305805 — A Research Study of a New Medicine NNC0363-1063 in Participants With Type 1 Diabetes · Phase 1 · recruiting
NCT06282055 — Trajectories in Insulin Sensitivity Across MEnstrual cycleS in Women With Type 1 Diabetes · recruiting
NCT06325202 — Closed Loop and Education for Hypoglycemia Awareness Restoration · NA · recruiting
NCT07160816 — A Research Study to See How Insulin Icodec Helps People With Type 1 Diabetes Control Their Blood Sugar · recruiting

Other Rabin Medical Center trials

Trials by the same sponsor.

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NCT06966427 — Prospective Evaluation of a Dose Guidance System for People With Diabetes Initiating Basal Insulin or Using Insulin Inje · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04269668 (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 Rabin Medical Center
Last refreshed: 22 February 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/NCT04269668.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing