A Randomized Clinical Trial to Assess the Efficacy of Adjunctive Closed Loop Control Versus Sensor-Augmented Pump Therapy in the Management of Type 1 Diabetes

Completed

• Conditions: diabetes mellitus; 10018424

• Registration Number: NL-OMON46319
• Lead Sponsor: Academisch medisch centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 34

Inclusion Criteria

Diagnosis of type 1 diabetes for at least one year and using insulin for at least 1 year
Use of an insulin pump for at least 6 months
Age >= 18
HbA1c level <10.5% at screening; if HbA1c <6.0% then total daily insulin must be >=0.5 U/kg
Access to internet and cell phone service at home

Exclusion Criteria

Medical need for chronic acetaminophen
Introduction of any glucose-lowering agent (such as Pramlintide, Metformin, GLP-1, Liraglutide, SGLT2 inhibitors) within the three months prior to enrollment
Hemophilia or any other bleeding disorder
More than one diabetic ketoacidosis (DKA) in the past 6 months
More than one severe hypoglycemia in the past 6 months
Use of a closed-loop system within the last month prior to enrollment
Employed by, or having immediate family members employed by TypeZero Technologies

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Difference in HbA1c improvement between the control-to-Range (CTR)<br /><br>Closed-Loop group and the sensor-controlled insulin pump group.<br /><br>- Difference in the sensor measured hypoglycemia between the control-to-Range<br /><br>(CTR) Closed-Loop group and the sensor-controlled insulin pump group.<br /><br><br /><br>Outcome measures of the the training protoco includesl: a qualitative<br /><br>assessment of the control-to-Range (CTR) Closed-Loop system to use it on a<br /><br>large scale at home.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Episodes of severe hypoglycemia<br /><br>- Episodes of diabetes ketoacidosis<br /><br>- Other serious adverse events</p><br>