Cystic Fibrosis-related DiabetesNCT03939065
Sensor Augmented Pump (SAP) Therapy for Inpatient CFRD Management
A study testing Sensor Augmented Pump Therapy in people with Cystic Fibrosis-related Diabetes and Cystic Fibrosis Pulmonary Exacerbation, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 25 years
- Conditions the study is for
- Cystic Fibrosis-related Diabetes, Cystic Fibrosis Pulmonary Exacerbation, Cystic Fibrosis in Children
- What is being tested?
- Sensor Augmented Pump Therapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2020to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado, University of Colorado Denver
Aurora, Colorado, 80045
About this study
Official title: 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.
- Conditions
- Cystic Fibrosis-related Diabetes, Cystic Fibrosis Pulmonary Exacerbation, Cystic Fibrosis in Children
- Being tested
- Sensor Augmented Pump Therapy, Standard of Care with CGM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensor Augmented Pump TherapyDevice
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 with CGMDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Insulin Pump and CGM | Experimental | Not described Receives: Device: Sensor Augmented Pump Therapy |
| Standard of Care and CGM | Other | Not described Receives: Device: Standard of Care with CGM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in CGM percent time over 140 mg/dl
Differences in percent time >140 mg/dl on CGM between groups
Measured: through study completion, up to 3 weeks
Secondary outcomes (4)
Change in Pulmonary Function
Change in Pulmonary Function, FEV1 (percent and L), from admission to 1 week
Measured: baseline and 1 week
Circulatory markers of inflammation
∆hsCRP and ∆calprotectin from admission to 1 week
Measured: baseline and 1 week
Weight change
Change in weight from admission to 1 week
Measured: baseline and 1 week
Statstrip glucose
glucose obtained from bedside glucometer (mg/dl)
Measured: through study completion, up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start12 Jun 2020
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Why it stopped: Decreased admissions secondary to wider introduction of HEMTs along with pandemic impacted ability to enroll
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic Fibrosis-related DiabetesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Responsible party
- Sponsor
- Investigators
- Christine Chan, MD, Principal investigator, christinel.chan@childrenscolorado.org
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03939065
- Sponsor's protocol ID
- 18-2602
- Status last verified
- Mar 2023
- First submitted
- 2 Apr 2019
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 34844283
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensor Augmented Pump (SAP) Therapy for Inpatient Cystic Fibrosis Related Diabetes (CFRD) Management
- ClinicalTrials.gov ID
- NCT03939065
- Acronym / sponsor ID
- 18-2602
- Conditions
- Cystic Fibrosis-related Diabetes, Cystic Fibrosis Pulmonary Exacerbation, Cystic Fibrosis in Children
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Decreased admissions secondary to wider introduction of HEMTs along with pandemic impacted ability to enroll
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Study start
- 12 Jun 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 6 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin Pump and CGM | Experimental | Device: Sensor Augmented Pump Therapy |
| Standard of Care and CGM | Other | Device: Standard of Care with CGM |
Who may qualify
- Ages
- 8 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensor Augmented Pump TherapyIncorporating 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. | Device | Insulin Pump and CGM |
| Standard of Care with CGMParticipants 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. | Device | Standard of Care and CGM |
Primary outcome
Differences in CGM percent time over 140 mg/dl
Time frame: through study completion, up to 3 weeks
Differences in percent time >140 mg/dl on CGM between groups
4 secondary outcomes
Change in Pulmonary Function
Time frame: baseline and 1 week
Circulatory markers of inflammation
Time frame: baseline and 1 week
Weight change
Time frame: baseline and 1 week
Statstrip glucose
Time frame: through study completion, up to 3 weeks
Results and safety
The study was stopped early (reason given: Decreased admissions secondary to wider introduction of HEMTs along with pandemic impacted ability to enroll). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Derived from this study: PubMed 34844283Toner 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Chan, MD principal investigator
christinel.chan@childrenscolorado.org
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensor Augmented Pump Therapy in people with Cystic Fibrosis-related Diabetes and Cystic Fibrosis Pulmonary Exacerbation, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Decreased admissions secondary to wider introduction of HEMTs along with pandemic impacted ability to enroll). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in CGM percent time over 140 mg/dl (time frame: through study completion, up to 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03939065, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2023.