NCT03939065

Sensor Augmented Pump (SAP) Therapy for Inpatient CFRD Management

Sensor Augmented Pump (SAP) Therapy for Inpatient Cystic Fibrosis Related Diabetes (CFRD) Management

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 8 Years – 25 Years
• Healthy volunteers: Not accepted

Summary

This research proposes a pilot study using the combination of continuous glucose monitor (CGM) and insulin pump therapy, also known as sensor augmented pump (SAP) therapy, for cystic fibrosis related diabetes (CFRD) management in the inpatient setting, with the aim of improving glycemic control.

Conditions

• Cystic Fibrosis-related Diabetes
• Cystic Fibrosis Pulmonary Exacerbation
• Cystic Fibrosis in Children

Interventions

Type	Name	Description
DEVICE	Sensor Augmented Pump Therapy	Incorporating both insulin pump and CGM technology together (also known as SAP therapy) has the potential to better optimize glycemic control than each device alone. Participants in this arm will receive their insulin dosing via insulin pump and their blood sugars will be monitored using a Continuous Glucose Monitor.
DEVICE	Standard of Care with CGM	Participants assigned to this arm will receive conventional diabetes management with daily insulin injections (or on an insulin pump if already on an insulin pump in the outpatient setting) and capillary blood glucose monitoring. These participants will also wear a blinded Continuous Glucose Monitor (CGM) for outcome assessment.

Timeline

• Start date: 2020-06-12
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2019-05-06
• Last updated: 2023-03-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study