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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/26/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/26/2021.

Sensor Augmented Pump (SAP) Therapy for Inpatient CFRD Management

Clinicaltrials.gov identifier NCT03939065

Recruitment Status Recruiting

First Posted May 6, 2019

Last update posted August 31, 2020

Study Description

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.

  • Condition or Disease:Cystic Fibrosis-related Diabetes
    Cystic Fibrosis Pulmonary Exacerbation
    Cystic Fibrosis in Children
  • Intervention/Treatment: Device: Sensor Augmented Pump Therapy
    Device: Standard of Care with CGM
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 36 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Sensor Augmented Pump (SAP) Therapy for Inpatient Cystic Fibrosis Related Diabetes (CFRD) Management
  • Actual Study Start Date: June 2020
  • Estimated Primary Completion Date: February 2023
  • Estimated Study Completion Date: February 2023
Arms and interventions
Arm Intervention/treatment
Experimental: Insulin Pump and CGM
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.
Other: Standard of Care and CGM
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.
Outcome Measures
  • Primary Outcome Measures: 1. Differences in CGM percent time over 140 mg/dl [ Time Frame: through study completion, up to 3 weeks ]
    Differences in percent time >140 mg/dl on CGM between groups
  • Secondary Outcome Measures: 1. Circulatory markers of inflammation [ Time Frame: baseline and 1 week ]
    ∆hsCRP and ∆calprotectin from admission to 1 week
  • 2. Weight change [ Time Frame: baseline and 1 week ]
    Change in weight from admission to 1 week
  • 3. Statstrip glucose [ Time Frame: through study completion, up to 3 weeks ]
    glucose obtained from bedside glucometer (mg/dl)
  • 4. Change in Pulmonary Function [ Time Frame: baseline and 1 week ]
    Change in Pulmonary Function, FEV1 (percent and L), from admission to 1 week
  • Other Outcome Measures: 1. beta-cell function [ Time Frame: within 24 hours of admission ]
    measures to be derived from oral glucose tolerance testing, including insulin and c-peptide area under the curve
Eligibility Criteria
  • Ages Eligible for Study: 8 to 25 Years (Child, Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

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

Contacts and Locations
Contacts

Contact: Rebekah Miller 720-777-2163 rebekah.miller@childrenscolorado.org

Contact: Christine Chan, MD 720-777-0990 christinel.chan@childrenscolorado.org

Locations

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

Sponsors and Collaborators

University of Colorado, Denver

Cystic Fibrosis Foundation

Investigators

Principal Investigator: Christine Chan, MD christinel.chan@childrenscolorado.org

More Information
  • Responsible Party: University of Colorado, Denver
  • ClinicalTrials.gov Identifier: NCT03939065 History of Changes
  • Other Study ID Numbers: 18-2602
  • First Posted: May 6, 2019 Key Record Dates
  • Last Update Posted: August 31, 2020
  • Last Verified: August 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: Yes
  • Product Manufactured in and Exported from the U.S.: Yes
  • Additional relevant MeSH terms: Cystic Fibrosis
    Pulmonary Fibrosis
    Fibrosis