closed-loop insulin delivery in pregnant women with type 1 diabetes: a randomized controlled trial

Completed

Conditions: 10018424
diabetes
diabetes mellitus type 1
10010273

Registration Number: NL-OMON49884

Lead Sponsor: niversitair Ziekenhuis Leuven

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

• Women with T1DM, diagnosed at least 1 year before pregnancy
• Age 18-45 years
• A singleton pregnancy confirmed by b-HCG in blood and/or ultrasound-confirmed
gestational age up to 11 weeks and 6 days.
• Treated with intensive insulin treatment (either MDI, insulin pump). A
closed-loop system can only be used in manual mode.
• HbA1c level <=10%.
• Participants need to speak and understand Dutch or English and have e-mail
access.

Exclusion Criteria

• The use of a closed-loop insulin delivery system in auto mode.
• A twin (multiple) pregnancy
• A physical or psychological disease likely to interfere with the conduct of
the study (based on the evaluation by the treating physician)
• Medications known to interfere with glucose metabolism
• A daily insulin dose of >=1.5 units/kg
• Known allergy to adhesives due to infusion set and/or continuous glucose
monitor

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>time in range (glucose 3.5-7.8 mmol/l)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Number and duration of hypoglycaemic episodes (time glucose <3.5 mmol/l, time<br /><br><2.8 mmol/l).<br /><br>* Glucose variability, mean glucose level and percentages of time in target<br /><br>overnight, during the day and evening.<br /><br>* Total insulin dose.<br /><br>* Continuous glucose monitoring compliance.<br /><br>* Treatment satisfaction.<br /><br>* Pregnancy outcomes.<br /><br>* The cost-effectiveness of the closed-loop system compared to standard of<br /><br>care.</p><br>