Cystic Fibrosis in Children, Cystic Fibrosis Pulmonary Exacerbation, Cystic Fibrosis-related Diabetes
Conditions
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.
Interventions
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.
DEVICEStandard 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
Cystic Fibrosis Foundation
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 25 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differences in CGM percent time over 140 mg/dl | through study completion, up to 3 weeks | Differences in percent time \>140 mg/dl on CGM between groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pulmonary Function | baseline and 1 week | Change in Pulmonary Function, FEV1 (percent and L), from admission to 1 week |
| Circulatory markers of inflammation | baseline and 1 week | ∆hsCRP and ∆calprotectin from admission to 1 week |
| Weight change | baseline and 1 week | Change in weight from admission to 1 week |
| Statstrip glucose | through study completion, up to 3 weeks | glucose obtained from bedside glucometer (mg/dl) |
Other
| Measure | Time frame | Description |
|---|---|---|
| beta-cell function | within 24 hours of admission | measures to be derived from oral glucose tolerance testing, including insulin and c-peptide area under the curve |
Countries
United States
Outcome results
None listed