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Decreased admissions secondary to wider introduction of HEMTs along with pandemic impacted ability to enroll
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| Name | Class |
|---|---|
| Cystic Fibrosis Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin Pump and CGM | Experimental |
| |
| Standard of Care and CGM | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sensor Augmented Pump Therapy | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pulmonary Function | Change in Pulmonary Function, FEV1 (percent and L), from admission to 1 week | baseline and 1 week |
| Circulatory markers of inflammation | ∆hsCRP and ∆calprotectin from admission to 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine Chan, MD | christinel.chan@childrenscolorado.org | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Colorado, University of Colorado Denver | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34844283 | Derived | Toner A, McCloy A, Dyce P, Nazareth D, Frost F. Continuous glucose monitoring systems for monitoring cystic fibrosis-related diabetes. Cochrane Database Syst Rev. 2021 Nov 29;11(11):CD013755. doi: 10.1002/14651858.CD013755.pub2. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 19, 2023 | May 9, 2023 | 8 | ||
| Feb 13, 2026 |
| ID | Term |
|---|---|
| D000095583 | Continuous Glucose Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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|
| Standard of Care with CGM | Device | 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. |
|
| baseline and 1 week |
| Weight change | Change in weight from admission to 1 week | baseline and 1 week |
| Statstrip glucose | glucose obtained from bedside glucometer (mg/dl) | through study completion, up to 3 weeks |
| Mar 5, 2026 |
| 9 |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |