Sensor Augmented Pump (SAP) Therapy for Inpatient CFRD Management

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

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.

Study Overview

• Status: Terminated
• Conditions: Cystic Fibrosis-related Diabetes; Cystic Fibrosis Pulmonary Exacerbation; Cystic Fibrosis in Children
• Intervention / Treatment: Device: Sensor Augmented Pump Therapy; Device: Standard of Care with CGM

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado, University of Colorado Denver

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Cystic Fibrosis Foundation
• Investigators: Principal Investigator: Christine Chan, MD, christinel.chan@childrenscolorado.org

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2020
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: April 2, 2019
• First Submitted That Met QC Criteria: May 2, 2019
• First Posted (Actual): May 6, 2019

Study Record Updates

• Last Update Posted (Actual): March 22, 2023
• Last Update Submitted That Met QC Criteria: March 20, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Pulmonary Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: 18-2602

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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