Sensor Augmented Pump (SAP) Therapy for Inpatient CFRD Management

NCT03939065 | Terminated FDA Device

• 1 other identifier: 18-2602
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in Pulmonary Function

  baseline and 1 week

• Circulatory markers of inflammation

  baseline and 1 week

• Weight change

  baseline and 1 week

• Statstrip glucose

  through study completion, up to 3 weeks

Other Outcomes (1)

• beta-cell function

  within 24 hours of admission

Study Arms (2)

Insulin Pump and CGM

EXPERIMENTAL

Device: Sensor Augmented Pump Therapy

Standard of Care and CGM

OTHER

Device: Standard of Care with CGM

Interventions

Sensor Augmented Pump Therapy DEVICE

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.

Insulin Pump and CGM

Standard of Care with CGM DEVICE

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.

Standard of Care and CGM

Eligibility Criteria

• Age: 8 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Cystic Fibrosis Foundation: collaborator

Study Sites (1)

Children's Hospital Colorado, University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• Toner A, McCloy A, Dyce P, Nazareth D, Frost F. Continuous glucose monitoring systems for monitoring cystic fibrosis-related diabetes. Cochrane Database Syst Rev. 2021 Nov 29;11(11):CD013755. doi: 10.1002/14651858.CD013755.pub2.

  PMID: 34844283 DERIVED

MeSH Terms

Interventions

Continuous Glucose Monitoring

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Christine Chan, MD

  christinel.chan@childrenscolorado.org

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: May 6, 2019
• Study Start: June 12, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: March 22, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)