UnknownNot Applicable

AHCL System Initiation in T1D Patients naïve to Technology

40 participantsStarted 2020-11-02

Plain-language summary

The primary objective of this study is to evaluate whether the MiniMed 780G AHCL system improves glycemic control and Quality of Life (QoL) perception in adult individuals with T1D and naïve to CSII and CGM technologies. The trial is a two-centers, randomized controlled, parallel group study. Patients will be followed up during approximatively 3 months.

Who can participate

Age range26 Years – 60 Years

SexALL

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Inclusion criteria

✓. Age 26 - 60 years at time of screening a clinical diagnosis of type 1 diabetes for 2 years or more as determined via medical record or source documentation by an individual qualified to make a medical diagnosis
✓. Willing to participate in a study for the specified duration
✓. Willing to perform ≥ 4 finger stick blood glucose measurements daily
✓. Willing to perform required sensor calibrations
✓. Willing to wear the system continuously throughout the study
✓. Glycosylated hemoglobin (A1C) value less than 10.0% at time of screening visit
✓. Treated with MDI
✓. Willing to perform at least 4 BGM/day, when on MDI

Exclusion criteria

✕. Previous treatment with CSII/CGM
✕. Usage of ultra-rapid insulins, e.g. FIASP
✕. concurrent illness
✕. laboratory abnormalities, or medications that might affect study participation,
✕. current pregnancy
✕. renal impairment
✕. hemoglobin A1c value above 10%.

What they're measuring

Between group TIR difference

Timeframe: Day 78-90

Trial details

NCT IDNCT04616391

SponsorJagiellonian University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-03-31

Contact for this trial

Bartłomiej Matejko, PhD

48124003552 b.matejko@uj.edu.pl

View on ClinicalTrials.gov More Diabetes Mellitus, Type 1 trials