Sensor Augmented Pump (SAP) Therapy for Inpatient CFRD Management

• Sponsor: University of Colorado, Denver (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03939065
• Collaborator: Cystic Fibrosis Foundation (Other)
• Enrollment: 36
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 23.6
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cystic Fibrosis-related Diabetes; Cystic Fibrosis Pulmonary Exacerbation; Cystic Fibrosis in Children	Device: Sensor Augmented Pump Therapy; Device: Standard of Care with CGM	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Sensor Augmented Pump (SAP) Therapy for Inpatient Cystic Fibrosis Related Diabetes (CFRD) Management
• Actual Study Start Date: Jun 12, 2020
• Anticipated Primary Completion Date: Jun 1, 2022
• Anticipated Study Completion Date: Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Insulin Pump and CGM	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.
Other: Standard of Care and CGM	Device: 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.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Change in Pulmonary Function [baseline and 1 week]

   Change in Pulmonary Function, FEV1 (percent and L), from admission to 1 week

2. Circulatory markers of inflammation [baseline and 1 week]

   ∆hsCRP and ∆calprotectin from admission to 1 week

3. Weight change [baseline and 1 week]

   Change in weight from admission to 1 week

4. Statstrip glucose [through study completion, up to 3 weeks]

   glucose obtained from bedside glucometer (mg/dl)

Other Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 25 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital Colorado, University of Colorado Denver	Aurora	Colorado	United States	80045

Sponsors and Collaborators

• University of Colorado, Denver
• Cystic Fibrosis Foundation

Investigators

• Principal Investigator: Christine Chan, MD, [e-mail]

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT03939065
• Other Study ID Numbers: 18-2602
• First Posted: May 6, 2019
• Last Update Posted: Jun 9, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Cystic Fibrosis; Pulmonary Fibrosis; Fibrosis

Study Results

No Results Posted as of Jun 9, 2021