Cystic Fibrosis in Children Clinical Trial
Official title:
Sensor Augmented Pump (SAP) Therapy for Inpatient Cystic Fibrosis Related Diabetes (CFRD) Management
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 |
Verified date | March 2023 |
Source | University of Colorado, Denver |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital Colorado, University of Colorado Denver | Aurora | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver | Cystic Fibrosis Foundation |
United States,
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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