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Sensor Augmented Pump (SAP) Therapy for Inpatient CFRD Management

Primary Purpose

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

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sensor Augmented Pump Therapy
Standard of Care with CGM
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis-related Diabetes

Eligibility Criteria

8 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital Colorado, University of Colorado Denver

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Insulin Pump and CGM

Standard of Care and CGM

Arm Description

Outcomes

Primary Outcome Measures

Differences in CGM percent time over 140 mg/dl
Differences in percent time >140 mg/dl on CGM between groups

Secondary Outcome Measures

Change in Pulmonary Function
Change in Pulmonary Function, FEV1 (percent and L), from admission to 1 week
Circulatory markers of inflammation
∆hsCRP and ∆calprotectin from admission to 1 week
Weight change
Change in weight from admission to 1 week
Statstrip glucose
glucose obtained from bedside glucometer (mg/dl)

Full Information

First Posted
April 2, 2019
Last Updated
March 20, 2023
Sponsor
University of Colorado, Denver
Collaborators
Cystic Fibrosis Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03939065
Brief Title
Sensor Augmented Pump (SAP) Therapy for Inpatient CFRD Management
Official Title
Sensor Augmented Pump (SAP) Therapy for Inpatient Cystic Fibrosis Related Diabetes (CFRD) Management
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Decreased admissions secondary to wider introduction of HEMTs along with pandemic impacted ability to enroll
Study Start Date
June 12, 2020 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Cystic Fibrosis Foundation

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis-related Diabetes, Cystic Fibrosis Pulmonary Exacerbation, Cystic Fibrosis in Children

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Insulin Pump and CGM
Arm Type
Experimental
Arm Title
Standard of Care and CGM
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Sensor Augmented Pump Therapy
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Standard of Care with CGM
Intervention Description
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.
Primary Outcome Measure Information:
Title
Differences in CGM percent time over 140 mg/dl
Description
Differences in percent time >140 mg/dl on CGM between groups
Time Frame
through study completion, up to 3 weeks
Secondary Outcome Measure Information:
Title
Change in Pulmonary Function
Description
Change in Pulmonary Function, FEV1 (percent and L), from admission to 1 week
Time Frame
baseline and 1 week
Title
Circulatory markers of inflammation
Description
∆hsCRP and ∆calprotectin from admission to 1 week
Time Frame
baseline and 1 week
Title
Weight change
Description
Change in weight from admission to 1 week
Time Frame
baseline and 1 week
Title
Statstrip glucose
Description
glucose obtained from bedside glucometer (mg/dl)
Time Frame
through study completion, up to 3 weeks
Other Pre-specified Outcome Measures:
Title
beta-cell function
Description
measures to be derived from oral glucose tolerance testing, including insulin and c-peptide area under the curve
Time Frame
within 24 hours of admission

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Chan, MD
Organizational Affiliation
christinel.chan@childrenscolorado.org
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Colorado, University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34844283
Citation
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.
Results Reference
derived

Learn more about this trial

Sensor Augmented Pump (SAP) Therapy for Inpatient CFRD Management

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