Dual hormone closed loop in type 1 diabetes: a randomized trial

• Conditions: diabetes; type 1; 10018424

• Registration Number: NL-OMON53641
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 240

Inclusion Criteria

* Age between 18 and 75 years;
* Diagnosed with type 1 diabetes mellitus at least one year ago;
* HbA1c * 91 mmol/mol;

Exclusion Criteria

* Current use of non-approved hybrid closed loop device;
* BMI >35 kg/m2;
* eGFR<30 mL/min/1.73m2;
* Plan to change usual diabetes regimen in the next 3 months;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study endpoint is the Time in Range (TIR; % of time spent in the<br /><br>3.9-10 mmol/l target range) at 12 months, which will be compared between the<br /><br>intervention and the control treatment within each arm. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints include cost-effectiveness, PROMs, other glycaemic<br /><br>outcomes, safety measures and device-related outcomes. </p><br>