Artificial pancreas with two hormones could ease diabetes management

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age between 18 and 75 years; * Diagnosed with type 1 diabetes mellitus at least one year ago; * HbA1c ≤ 91 mmol/mol; * Treated with either MDI with FGM/CGM or treated with HCL: * MDI+FGM/CGM for ≥ 3 months with an adequate sensor use during at least 70% of the time in the month prior to screening (based on sensor usage from the download summary report of the FGM/CGM); * HCL for ≥ 3 months with a frequency of use ≥ 70% of the time in auto mode over the previous month prior to screening; * Does not reach the treatment goals over the last 8 weeks: * for MDI+FGM/CGM: subject has a TIR \<80% or Time Below Range (TBR) \>4%; * for HCL: subject has a TIR \<80% or TBR \>4%; * Willing to take or switch to insulin Humalog when randomized to the intervention DHFCL arm; * Under treatment in one of the participating centres; * Willing and able to sign informed consent; * Access to internet at home (for DHFCL data upload). Exclusion Criteria: * Current use of non-approved HCL device; * BMI \>35 kg/m2; * eGFR\<30 mL/min/1.73m2; * Plan to change usual diabetes regimen in the next 3 months; * Current participation in another diabetes-related clinical trial; * Actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or device in the last 2 weeks before enrolment into this study, as per investigator judgment; * Established history of allergy or severe reaction to adhesive or tape that must be used in the study; * Use of oral glucose-lowering medication; * Active retinopathy or painful neuropathy; * Daily use of acetaminophen during the trial (all arms), as this may influence the sensor glucose measurements. Incidental use with a maximum of e.g. 3 daily doses of 1000mg paracetamol for a maximum of 3 consecutive days is allowed * Limited ability to see, and to hear or feel alarm signals of the closed loop system; * Current pregnancy, breast feeding or planning to become pregnant in the 12 months of the trial or using ineffective birth control methods; * Presence of a medical or psychiatric condition, longstanding serious adherence problems, anticipated problems in handing over diabetes control to a device or use of a medication that, in the judgment of the investigator, clinical protocol chair, or medical monitor, could compromise the results of the study or the safety of the participant.