Type 1 DiabetesEarly Phase 1NCT01954459
Warming up to Sensors: Does Site Warming Improve Continuous Glucose Monitor Performance?
A Early Phase 1 study testing Insupatch and Continuous glucose sensor in people with Type 1 Diabetes, run by Yale University at 1 site in United States.
Trial summary
This study will investigate the effect of wearing a small warming patch, the InsuPatch, at the site of the continuous glucose monitor (CGM), also called a sensor. Specifically, we will be looking to see if using the InsuPatch (IP) improves the accuracy of the continuous glucose monitor. Read more about this study
- Who is it for?
- Ages 8 to 44 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Insupatch and Continuous glucose sensor
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Jun 2016
- Phase
- Early Phase 1
- 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 44 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least 12 months.
- Age 8 years to less than 45 years old.
- Subject understands the study protocol and agree to comply with it.
- Subject is on insulin pump or injection-based basal-bolus therapy
- Subject comprehends written English.
- For females, subject not intending to become pregnant during the study.
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- Informed Consent Form signed by the subject
- No history of altered skin integrity, poor wound healing, adhesive allergy, or previous infection from sensor wear.
- Hemoglobin A1C ≤10%
Who cannot join
- The presence of a significant medical disorder that in the judgment of the investigator will affect the wearing of the sensors or the completion of any aspect of the protocol
- The presence of any of the following diseases:
- Current use of systemic corticosteroids (within the last week) b. Other major illness that in the judgment of the investigator might interfere with the completion of the protocol i. Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment
- Inpatient psychiatric treatment in the past 6 months for either the subject or the subject's primary care giver (i.e., parent or guardian)
- Current or past use of a continuous glucose sensor is not an exclusion criterion.
- Active skin condition that would affect sensor placement
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- Use of acetaminophen or Vitamin C supplement within the last 7 days
- Subject is deemed by the Investigator to be unwilling or unable to follow the protocol;
- Pregnancy A negative urine pregnancy test will be required for all premenopausal women who are not surgically sterile. Subjects who become pregnant will be discontinued from the study.
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Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University School of Medicine
New Haven, Connecticut, 06520
About this study
This study will investigate the effect of wearing a small warming patch, the InsuPatch, at the site of the continuous glucose monitor (CGM), also called a sensor. Specifically, we will be looking to see if using the InsuPatch (IP) improves the accuracy of the continuous glucose monitor.
Read the detailed description
Hypotheses:
- Warming of the skin and subcutaneous tissue with the InsuPatch device will improve the accuracy of a CGM as compared to a CGM used alone when both are calibrated with a standard laboratory quality glucose measuring reference standard.
- Warming of the skin and subcutaneous tissue with the InsuPatch device will reduce the lag time of the CGM, as compared to a CGM used alone when both are calibrated with a standard laboratory quality glucose measuring reference standard.
- The combination of the InsuPatch device and a CGM will be well-tolerated and not cause skin irritation.
- Conditions
- Type 1 Diabetes
- Being tested
- Insupatch, Continuous glucose sensor
- Keywords
- Type 1 diabetes, Continuous glucose sensor, Insupatch
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsupatchDevice
Device which applies local heating at 40 degrees Celsius to the vicinity of the subcutaneous site of glucose sensor.
Continuous glucose sensorDevice
Glucose sensor inserted without warming patch
| Study group | Role | What they receive |
|---|---|---|
| Sensor alone | Active comparator | Glucose sensor site will not have Insupatch Receives: Device: Continuous glucose sensor |
| Sensor with Insupatch | Experimental | Glucose sensor site with Insupatch Receives: Device: Insupatch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Point accuracy of the continuous glucose monitor plus Insupatch (CGM+IP) by mean absolute relative difference (MARD) calculation of sensors with and without IP use.
Point accuracy of the continuous glucose monitor plus Insupatch (CGM+IP) by mean absolute relative difference (MARD) calculation of sensors with and without IP use, comparing sensor glucose readings and signal data to serum Yellow Springs Instrument (YSI) glucose measurements, with each subject acting as his or her own control.
Measured: 4 hours after lunch, 8 hours after breakfast
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionJun 2016
- Study completionJun 2016
Why it stopped: unable to complete due to lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Camille Michaud, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01954459
- Sponsor's protocol ID
- 1306012208
- Other IDs
- R01DK085618-01
- Status last verified
- Mar 2020
- First submitted
- 26 Sep 2013
- Last updated
- 9 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Warming up to Sensors: Does Site Warming Improve Continuous Glucose Monitor Performance?
- ClinicalTrials.gov ID
- NCT01954459
- Acronym / sponsor ID
- 1306012208
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 diabetes, Continuous glucose sensor, Insupatch
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: unable to complete due to lack of funding
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Sep 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 1 Oct 2013 (estimated)
- 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 study will investigate the effect of wearing a small warming patch, the InsuPatch, at the site of the continuous glucose monitor (CGM), also called a sensor. Specifically, we will be looking to see if using the InsuPatch (IP) improves the accuracy of the continuous glucose monitor.
Detailed description
Hypotheses:
- Warming of the skin and subcutaneous tissue with the InsuPatch device will improve the accuracy of a CGM as compared to a CGM used alone when both are calibrated with a standard laboratory quality glucose measuring reference standard.
- Warming of the skin and subcutaneous tissue with the InsuPatch device will reduce the lag time of the CGM, as compared to a CGM used alone when both are calibrated with a standard laboratory quality glucose measuring reference standard.
- The combination of the InsuPatch device and a CGM will be well-tolerated and not cause skin irritation.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sensor alone | Active comparator | Device: Continuous glucose sensorGlucose sensor site will not have Insupatch |
| Sensor with Insupatch | Experimental | Device: InsupatchGlucose sensor site with Insupatch |
Who may qualify
- Ages
- 8 to 44 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least 12 months.
- Age 8 years to less than 45 years old.
- Subject understands the study protocol and agree to comply with it.
- Subject is on insulin pump or injection-based basal-bolus therapy
- Subject comprehends written English.
Key exclusion criteria (10 listed)
- The presence of a significant medical disorder that in the judgment of the investigator will affect the wearing of the sensors or the completion of any aspect of the protocol
- The presence of any of the following diseases:
- Inpatient psychiatric treatment in the past 6 months for either the subject or the subject's primary care giver (i.e., parent or guardian)
- Current or past use of a continuous glucose sensor is not an exclusion criterion.
- Active skin condition that would affect sensor placement
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 |
|---|---|---|
| InsupatchDevice which applies local heating at 40 degrees Celsius to the vicinity of the subcutaneous site of glucose sensor. | Device | Sensor with Insupatch |
| Continuous glucose sensorGlucose sensor inserted without warming patch | Device | Sensor alone |
Primary outcome
Point accuracy of the continuous glucose monitor plus Insupatch (CGM+IP) by mean absolute relative difference (MARD) calculation of sensors with and without IP use.
Time frame: 4 hours after lunch, 8 hours after breakfast
Point accuracy of the continuous glucose monitor plus Insupatch (CGM+IP) by mean absolute relative difference (MARD) calculation of sensors with and without IP use, comparing sensor glucose readings and signal data to serum Yellow Springs Instrument (YSI) glucose measurements, with each subject acting as his or her own control.
Results and safety
The study was stopped early (reason given: unable to complete due to lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2020.
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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.
Camille Michaud, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Insupatch and Continuous glucose sensor in people with Type 1 Diabetes, run by Yale University 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 9 inclusion and 10 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 9 Mar 2020. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: unable to complete due to lack of funding). 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?
Point accuracy of the continuous glucose monitor plus Insupatch (CGM+IP) by mean absolute relative difference (MARD) calculation of sensors with and without IP use. (time frame: 4 hours after lunch, 8 hours after breakfast). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Mar 2020.