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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

NCT04269668 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2022-02-22

No results posted yet for this study

Summary

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

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DEVICE

Medtronic Minimed 670G 3.0 HCL

Hybrid closed loop system

DEVICE

Medtronic Minimed 670G 4.0 AHCL

Advanced hybrid closed loop system

Sponsors & Collaborators

  • GIF

    collaborator UNKNOWN

  • Medtronic

    collaborator INDUSTRY

  • Rabin Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
7 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-19
Primary Completion
2021-02-20
Completion
2021-03-20
FDA Device
Yes

Countries

  • Germany
  • Israel

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04269668 on ClinicalTrials.gov