Sensor Augmented Pump (SAP) Therapy for Inpatient CFRD Management

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-12

Study Completion Date

2022-06-30

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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Insulin Pump and CGM

Group Type EXPERIMENTAL

Sensor Augmented Pump Therapy

Intervention Type 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.

Standard of Care and CGM

Group Type OTHER

Standard of Care with CGM

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

8 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No