CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 122 enrolled
Drug / intervention
MDI +1 moreother
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/NCT04235504
NCT04235504N/ACompleted
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ADvanced Hybrid Closed Loop Study in Adult Population With Type 1 Diabetes

Medtronic MiniMed, Inc.·interventional·Posted Jan 22, 2020·Updated Mar 27, 2023

In Brief

A clinical study evaluating MDI and AHCL for Type 1 Diabetes. Completed, enrolled 122 participants across 14 sites in 3 countries.

Detailed Summary

The purpose of this study evaluate the safety and efficacy of the Advanced Hybrid Closed Loop (AHCL) system in sub-optimally controlled patients with T1D, in comparison with Multiple Daily Injection (MDI) therapy with Flash Glucose Monitoring (FGM) or Continuous Glucose Monitoring (CGM). Patient with a diagnosis of Type 1 diabetes currently under MDI+ FGM or MDI+ CGM therapy will be enrolled.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes
CountriesFrance, Germany, United Kingdom
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJan 22, 2020
Enrollment StartJul 13, 2020
Primary CompletionDec 2, 2021
Study CompletionMay 30, 2022
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 6.4 years ago

Interventions

MDIother

Subject continues their standard Multiple Daily Injections therapy with FGM or RT-CGM

AHCLdevice

Subject starts using the Advance Hybrid Close Loop (AHCL) MiniMed™ 670G system version 4.0. Starting time depends on which Arm the subject is assigned to: if the subject is assigned to the Treatment Arm, then the intervention starts after the RUN-IN period. If the subject is assigned to the Control Arm the intervention will start after 6 months from the date of the enrollment.