Dual Hormone Closed Loop in Type 1 Diabetes

Prior treatment

• 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;

Other illness

• Plan to change usual diabetes regimen in the next 3 months;
• Current participation in another diabetes-related clinical trial;
• Established history of allergy or severe reaction to adhesive or tape that must be used in the study;
• 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.

Lab values

• eGFR\<30 mL/min/1.73m2;
• Use of oral glucose-lowering medication;
• 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

Other

• Current use of non-approved HCL device;
• BMI \>35 kg/m2;
• Active retinopathy or painful neuropathy;
• 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;

• 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).