Type1diabetesNCT05562206
CGMIS 48-hour Feasibility Study
A study testing CGMIS (Continuous Glucose Monitoring Infusion Set) in people with Type1diabetes, run by Pacific Diabetes Technologies at 1 site in United States.
Trial summary
This is a single center, single arm non-randomized study of 48-hour CGMIS wear duration incorporating two meal-challenge tests to explore the performance of a single insertion combined glucose-sensing insulin delivery cannula. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Type1diabetes
- What is being tested?
- CGMIS (Continuous Glucose Monitoring Infusion Set)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2022to Nov 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Type 1 diabetes, present for at least 6 months. If there is lack of clarity regarding the type of diabetes, the PI will make the final decision based on medical records.
- Age 18-75
- Currently using a Tandem T-Slim or Medtronic 523/723 or newer series insulin pump to treat their diabetes.
- Hgb A1C between 5.8 and 10%
- Willingness to follow all study procedures and to attend all clinic visits.
- Willingness to sign informed consent and HIPPA documents.
Who cannot join
- Need for MRI/CT/Diathermy during study participation
- Current use of Hydroxyurea
- History of chronic kidney disease
- Inability to read pump or CGM display due to reduced visual acuity
- History of unstable ischaemic heart disease or myocardial infarction within the last 3 months.
- History of chronic liver disease
Show all 22Show fewer
- Active infection such as HIV or hepatitis
- Anemia defined by HCT at least 4 percentage points below lower limit of the reference range
- Dementia, Schizophrenia or other untreated mental illness
- Chronic substance abuse
- Chronic alcohol abuse
- Seizure disorder
- Major surgical operation within 30 days prior to screening
- History of bleeding disorder or treatment with anticoagulants.
- Allergy to acrylate-based skin adhesives
- Ongoing use of an investigational drug or device
- Female of childbearing potential who is pregnant or intending to become pregnant
- Diabetic ketoacidosis or hypoglycemia requiring hospitalization within the last 6 months
- Insulin resistance as defined by insulin requirement of more than 200 units per day
- Use of glucose-lowering medications other than insulin
- Need for uninterrupted treatment with acetaminophen
- Any other physical or mental condition judged by the PI as being exclusionary.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Rainier Clinical Research Center
Renton, Washington, 98057
Ronald Brazg, MD, 425-251-1720, rbrazg@rainier-research.com
About this study
Official title: A 48hr Study to Test Feasibility of the Pacific Diabetes Technologies Continuous Glucose Monitor Infusion Set (CGMIS) Sensing Interstitial Glucose Continuously in the Immediate Vicinity of SQ Insulin Delivery in Adults With T1 Diabetes
This is a single center, single arm non-randomized study of 48-hour CGMIS wear duration incorporating two meal-challenge tests to explore the performance of a single insertion combined glucose-sensing insulin delivery cannula.
- Conditions
- Type1diabetes
- Being tested
- CGMIS (Continuous Glucose Monitoring Infusion Set)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGMIS (Continuous Glucose Monitoring Infusion Set)Device
An integrated combination CGM/insulin infusion system
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | All subjects using the study device Receives: Device: CGMIS (Continuous Glucose Monitoring Infusion Set) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy
Sensor accuracy as determined by mean absolute difference (MAD) for reference YSI venous blood glucose values ≤75 mg/dL and mean absolute relative difference (MARD) for reference YSI venous blood glucose values >75 mg/dL
Measured: First 48 hours
Accuracy
- Sensor accuracy in the performance metrics described in the FDA iCGM Special Controls.
Measured: First 48 hours
Secondary outcomes (4)
Number of subjects who discontinue delivery of insulin through the device due to unexplained hyperglycemia
this will be the number of subjects who experience unexplained glycemic excursions requiring a cannula change
Measured: First 48 hours
Results of tolerability questionnaire
A tolerability questionnaire will assess level of discomfort (none to severe), and duration.
Measured: First 48 hours
Results of Draize scale
Draize scale will be used by study staff to evaluate the presence and severity of erythema and edema at the site of device use after removal.
Measured: Firts 48 hours
Visual Analog Scale (VAS) for site discomfort
Subject will place a mark along a 100mm line to denote visually their perceived intensity of discomfort. Results will range from no discomfort to worst possible discomfort.
Measured: First 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start30 Aug 2022
- Primary completionOct 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1diabetesStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pacific Diabetes Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05562206
- Sponsor's protocol ID
- CIP-01
- Status last verified
- Sep 2022
- First submitted
- 26 Sep 2022
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 48hr Study to Test Feasibility of the Pacific Diabetes Technologies Continuous Glucose Monitor Infusion Set (CGMIS) Sensing Interstitial Glucose Continuously in the Immediate Vicinity of SQ Insulin Delivery in Adults With T1 Diabetes
- ClinicalTrials.gov ID
- NCT05562206
- Acronym / sponsor ID
- CIP-01
- Conditions
- Type1diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Pacific Diabetes TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 30 Aug 2022 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 30 Sep 2022 (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 is a single center, single arm non-randomized study of 48-hour CGMIS wear duration incorporating two meal-challenge tests to explore the performance of a single insertion combined glucose-sensing insulin delivery cannula.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Device: CGMIS (Continuous Glucose Monitoring Infusion Set)All subjects using the study device |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Type 1 diabetes, present for at least 6 months. If there is lack of clarity regarding the type of diabetes, the PI will make the final decision based on medical records.
- Age 18-75
- Currently using a Tandem T-Slim or Medtronic 523/723 or newer series insulin pump to treat their diabetes.
- Hgb A1C between 5.8 and 10%
- Willingness to follow all study procedures and to attend all clinic visits.
Key exclusion criteria (22 listed)
- Need for MRI/CT/Diathermy during study participation
- Current use of Hydroxyurea
- History of chronic kidney disease
- Inability to read pump or CGM display due to reduced visual acuity
- History of unstable ischaemic heart disease or myocardial infarction within the last 3 months.
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 |
|---|---|---|
| CGMIS (Continuous Glucose Monitoring Infusion Set)An integrated combination CGM/insulin infusion system | Device | Study group |
Primary outcome
Accuracy
Time frame: First 48 hours
Sensor accuracy as determined by mean absolute difference (MAD) for reference YSI venous blood glucose values ≤75 mg/dL and mean absolute relative difference (MARD) for reference YSI venous blood glucose values >75 mg/dL
Accuracy
Time frame: First 48 hours
• Sensor accuracy in the performance metrics described in the FDA iCGM Special Controls.
4 secondary outcomes
Number of subjects who discontinue delivery of insulin through the device due to unexplained hyperglycemia
Time frame: First 48 hours
Results of tolerability questionnaire
Time frame: First 48 hours
Results of Draize scale
Time frame: Firts 48 hours
Visual Analog Scale (VAS) for site discomfort
Time frame: First 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CGMIS (Continuous Glucose Monitoring Infusion Set) in people with Type1diabetes, run by Pacific Diabetes Technologies 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 6 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 30 Sep 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bob Janowski (818-395-6576, bjanowski@pacificdt.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy (time frame: First 48 hours). The study lists 2 primary outcomes in all. 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 30 Sep 2022.