Sensor Augmented Pump (SAP) Therapy for Inpatient CFRD Management

University of Colorado Denver (CU Denver)

Status: Terminated

Conditions: Cystic Fibrosis-related Diabetes; Cystic Fibrosis in Children; Cystic Fibrosis Pulmonary Exacerbation

Treatments: Device: Standard of Care with CGM; Device: Sensor Augmented Pump Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03939065

18-2602

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 8 to 25 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥8 years
2. Confirmed diagnosis of CF by consensus guidelines [50]
3. Diagnosis of CFRD based on American Diabetes Association and CFF criteria [51]
4. Admission for pulmonary exacerbation

Exclusion criteria

1. Known type 1 or type 2 diabetes, monogenic diabetes (MODY)
2. Critical illness requiring admission to the intensive care unit
3. Admission for indications other than pulmonary exacerbation (ex. Distal intestinal obstructive syndrome, surgery)
4. Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

Insulin Pump and CGM

Experimental group

Treatment:

Device: Sensor Augmented Pump Therapy

Standard of Care and CGM

Other group

Treatment:

Device: Standard of Care with CGM