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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03939065
Other study ID # 18-2602
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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