CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 34 enrolled
Drug / intervention
Advanced Hybrid Closed Loop Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04509362
NCT04509362N/ACompleted

An 8-Day Initiation Protocol of Advanced Hybrid Closed Loop System In Children and Adolescents With Diabetes Type 1 On Multiple Daily Insulin Injection

Sidra Medicine·observational·Posted Aug 12, 2020·Updated Sep 28, 2021

In Brief

An observational study evaluating Advanced Hybrid Closed Loop System for Type 1 Diabetes. Completed, enrolled 34 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes
CountriesQatar
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedAug 12, 2020
Enrollment StartOct 1, 2020
Primary CompletionMay 31, 2021
Study CompletionSep 1, 2021
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 5.9 years ago

Interventions

Advanced Hybrid Closed Loop Systemdevice

Evaluation of the use of an 8-day structured protocol to initiate patients from MDI to the AHCL system, in achieving safe glycemic control