Sensor Augmented Pump (SAP) Therapy for Inpatient CFRD Management

Study Overview
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Brief Summary
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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.

Official Title
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Sensor Augmented Pump (SAP) Therapy for Inpatient Cystic Fibrosis Related Diabetes (CFRD) Management

Conditions
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Cystic Fibrosis-related Diabetes, Cystic Fibrosis Pulmonary Exacerbation, Cystic Fibrosis in Children

Intervention / Treatment
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* Device: Sensor Augmented Pump Therapy
* Device: Standard of Care with CGM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥8 years Confirmed diagnosis of CF by consensus guidelines [50] Diagnosis of CFRD based on American Diabetes Association and CFF criteria [51] Admission for pulmonary exacerbation Exclusion Criteria: Known type 1 or type 2 diabetes, monogenic diabetes (MODY) Critical illness requiring admission to the intensive care unit Admission for indications other than pulmonary exacerbation (ex. Distal intestinal obstructive syndrome, surgery) Pregnancy

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Insulin Pump and CGM<br> | Device: Sensor Augmented Pump Therapy<br>* 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.<br>|
| Other: Standard of Care and CGM<br> | Device: Standard of Care with CGM<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |