Sensor Augmented Pump (SAP) Therapy for Inpatient CFRD Management

Cystic Fibrosis in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03939065
• Other study ID #: 18-2602
• Status: Terminated
• Phase: N/A
• Start date: June 12, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: March 2023
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Children's Hospital Colorado, University of Colorado Denver	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Cystic Fibrosis Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	beta-cell function	measures to be derived from oral glucose tolerance testing, including insulin and c-peptide area under the curve	within 24 hours of admission
Primary	Differences in CGM percent time over 140 mg/dl	Differences in percent time >140 mg/dl on CGM between groups	through study completion, up to 3 weeks
Secondary	Change in Pulmonary Function	Change in Pulmonary Function, FEV1 (percent and L), from admission to 1 week	baseline and 1 week
Secondary	Circulatory markers of inflammation	?hsCRP and ?calprotectin from admission to 1 week	baseline and 1 week
Secondary	Weight change	Change in weight from admission to 1 week	baseline and 1 week
Secondary	Statstrip glucose	glucose obtained from bedside glucometer (mg/dl)	through study completion, up to 3 weeks