Sensor Augmented Pump (SAP) Therapy for Inpatient CFRD Management

Not Applicable

Terminated

• Conditions: Cystic Fibrosis-related Diabetes; Cystic Fibrosis Pulmonary Exacerbation; Cystic Fibrosis in Children
• Interventions: Device: Standard of Care with CGM; Device: Sensor Augmented Pump Therapy

• Registration Number: NCT03939065
• Lead Sponsor: University of Colorado, Denver

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-02
• Study First Submitted QC: 2019-05-02
• Study First Posted: 2019-05-06
• Study Start: 2020-06-12
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-20
• Last Update Posted: 2023-03-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care and CGM	Standard of Care with CGM	-
Insulin Pump and CGM	Sensor Augmented Pump Therapy	-

Primary Outcome Measures

Name	Time	Method
Differences in CGM percent time over 140 mg/dl	through study completion, up to 3 weeks	Differences in percent time \>140 mg/dl on CGM between groups

Secondary Outcome Measures

Name	Time	Method
Change in Pulmonary Function	baseline and 1 week	Change in Pulmonary Function, FEV1 (percent and L), from admission to 1 week
Weight change	baseline and 1 week	Change in weight from admission to 1 week
Statstrip glucose	through study completion, up to 3 weeks	glucose obtained from bedside glucometer (mg/dl)
Circulatory markers of inflammation	baseline and 1 week	∆hsCRP and ∆calprotectin from admission to 1 week

Trial Locations

Locations (1)

Children's Hospital Colorado, University of Colorado Denver; 🇺🇸 Aurora, Colorado, United States