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Sensor Augmented Pump (SAP) Therapy for Inpatient CFRD Management

NCT03939065 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2023-03-22

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Cystic Fibrosis Foundation

    collaborator OTHER

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-12
Primary Completion
2022-06-30
Completion
2022-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03939065 on ClinicalTrials.gov