Type 1 Diabetes MellitusNCT03528174
Single Hormone Closed Loop Study With PDT Sensor
A study testing Pacific Diabetes Technologies CGM Insulin Infusion system in people with Type 1 Diabetes Mellitus, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The study described within this protocol is designed to test a single hormone closed-loop algorithm for managing blood glucose in type 1 diabetes using insulin only and a new device for measuring glucose continuously in the immediate vicinity of subcutaneous insulin delivery. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Pacific Diabetes Technologies CGM Insulin Infusion system
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2018to 1 Jul 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of type 1 diabetes mellitus for at least 1 year.
- Male or female subjects 21 to 65 years of age.
- Current use of an insulin pump for at least 3 months with stable insulin pump settings for > 2 weeks.
- HbA1c ≤ 10% at screening.
- Body Mass Index ≥ 22.
- Total daily insulin requirement is less than 200 units/day.
- Willingness to follow all study procedures, including attending all clinic visits.
- Willingness to sign informed consent and HIPAA documents.
Who cannot join
- Female of childbearing potential who is pregnant or intending to become pregnant or breast-feeding, or is not using adequate contraceptive methods. Acceptable contraception includes birth control pill / patch / vaginal ring, Depo-Provera, Norplant, an IUD, the double barrier method (the woman uses a diaphragm and spermicide and the man uses a condom), or abstinence.
- Any cardiovascular disease, defined as a clinically significant EKG abnormality at the time of screening or any history of: stroke, heart failure, myocardial infarction, angina pectoris, or coronary arterial bypass graft or angioplasty. Diagnosis of 2nd or 3rd degree heart block or any non-physiological arrhythmia judged by the investigator to be exclusionary.
- Renal insufficiency (GFR < 60 ml/min, using the MDRD equation as reported by the OHSU laboratory).
- Liver failure, cirrhosis, or any other liver disease that compromises liver function as determined by the investigator.
- Hematocrit of less than 36% for men, less than 32% for women.
- History of severe hypoglycemia during the past 12 months prior to screening visit or hypoglycemia unawareness as judged by the investigator.
Show all 25Show fewer
- History of Diabetic Ketoacidosis during the prior 6 months prior to screening visit, as diagnosed on hospital admission or as judged by the investigator.
- Adrenal insufficiency.
- Any active infection.
- Known or suspected abuse of alcohol, narcotics, or illicit drugs.
- Seizure disorder.
- Active foot ulceration.
- Severe peripheral arterial disease characterized by ischemic rest pain or severe claudication.
- Major surgical operation within 30 days prior to screening.
- Use of an investigational drug within 30 days prior to screening.
- Chronic usage of any immunosuppressive medication (such as cyclosporine, azathioprine, sirolimus, or tacrolimus).
- Bleeding disorder, treatment with warfarin, or platelet count below 50,000.
- Allergy to lispro insulin.
- Allergy to acrylate-based skin adhesives.
- Need for uninterrupted treatment of acetaminophen.
- Current administration of oral or parenteral corticosteroids.
- Any life threatening disease, including malignant neoplasms and medical history of malignant neoplasms within the past 5 years prior to screening (except basal and squamous cell skin cancer).
- Beta blockers or non-dihydropyridine calcium channel blockers.
- Current use of any medication intended to lower glucose other than insulin (ex. use of liraglutide).
- Any clinically significant disease or disorder which in the opinion of the Investigator may jeopardize the subject's safety or compliance with the protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science University
Portland, Oregon, 97239
About this study
Official title: Assessment of a Novel Sensing Catheter During Automated Insulin Delivery in Patients With Type 1 Diabetes
The study described within this protocol is designed to test a single hormone closed-loop algorithm for managing blood glucose in type 1 diabetes using insulin only and a new device for measuring glucose continuously in the immediate vicinity of subcutaneous insulin delivery. Subjects will undergo one all day closed loop study using insulin only. The closed loop insulin only system includes a Dexcom G5 transmitter, a Nexus 5 smart phone and two Tandem tslim pumps connected to two Pacific Diabetes Technologies glucose sensing cannulas. The closed loop system will be started after G5 2 hour sensor start-up with an IV catheter for frequent blood withdrawal for 10 hours.
Read the detailed description
Subjects will undergo one 12 hour inpatient study. During this intervention visit, subjects will wear the single hormone closed loop system which includes two t:slim insulin pumps to deliver insulin or saline through two investigational PDT glucose sensing cannulas, and a Dexcom G5 CGM to measure glucose. The subject will come to the research center at approximately 7am for the inpatient visit. The Dexcom G5 sensor and PDT glucose sensing cannulas will be placed after arrival. An 18-22 gauge IV catheter will be placed for blood sampling every 15 minutes after sensor warm-up is complete for measuring blood glucose concentration. After a 2 hour warm-up period for the G5 sensor, glucose will be controlled using the FMPD single hormone mode. The single hormone mode of the controller determines insulin delivery rates based on proportional and derivative error through one t:slim insulin pump. The second t:slim insulin pump will deliver normal saline at the same delivery rates as the insulin. Subjects will eat breakfast and lunch at approximately 11 am and 3 pm respectively. Subjects will have the ability to complete light exercise on a treadmill. The closed loop system will be stopped at approximately 6pm with removal of all devices.
During the study, the subject will wear one subcutaneous DexcomTM G5 continuous glucose monitoring (CGM) system. The CGM system will provide sensed glucose data every 5 minutes. The accuracy of the sensed data will be obtained by reference measurements of two YSI venous blood glucose values to calibrate the sensor at the beginning of the closed loop study. Sensed glucose data will be wirelessly transmitted via Bluetooth Low Energy (BTLE) from the Dexcom G5 transmitter to the Nexus 5 master controller every five minutes. The controller is a Google Nexus 5 phone. The smart phone will wirelessly communicate via BTLE to two Tandem t:slim insulin pumps, one for automated insulin delivery and one of automated saline delivery.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Artificial Pancreas Control system (APC), Pacific Diabetes Technologies CGM Insulin Infusion system
- 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.
Artificial Pancreas Control system (APC)Device
This intervention is a single hormone closed loop system including a Nexus 5 smart phone, two tslim insulin pumps, a Dexcom G5 CGM and two PDT glucose sensing cannulas that together make up a new experimental, investigational device system. The algorithm included in the APC is an automated version of the Fading Memory Proportional Derivative (FMPD) insulin and glucagon control algorithm.
Pacific Diabetes Technologies CGM Insulin Infusion systemDevice
An integrated combination CGM/insulin infusion system
| Study group | Role | What they receive |
|---|---|---|
| Single Hormone closed loop | Experimental | Subjects will have glucose managed using the Artificial Pancreas Control system (APC) using insulin only. Insulin will be infused through the Pacific Diabetes Technologies CGM Insulin Infusion system. Receives: Device: Artificial Pancreas Control system (APC); Device: Pacific Diabetes Technologies CGM Insulin Infusion system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Absolute Relative Difference of Sensed Glucose Values
Assess the mean absolute relative difference for the PDT CGM/insulin infusion system based on all reference YSI venous blood glucose values.
Measured: up to 10 hours
Secondary outcomes (13)
Percent of Time With Sensed Glucose Between 70-180 mg/dl
Assess the percent of time with sensed glucose between 70-180 mg/dl based on the Dexcom G5 CGM sensor values for all subjects.
Measured: up to 10 hours
Percent of Time With Sensed Glucose Less Than 70 mg/dl
Assess the percent of time with sensed glucose less than 70 mg/dl based on the Dexcom G5 CGM sensor values for all subjects.
Measured: up to 10 hours
Percent of Time With Sensed Glucose Less Than 54 mg/dl
Assess the percent of time with sensed glucose less than 54 mg/dl based on the Dexcom G5 CGM sensor values for all subjects.
Measured: up to 10 hours
Percent of Time With Sensed Glucose Greater Than 250 mg/dl
Assess the percent of time with sensed glucose greater than 250 mg/dl based on the Dexcom G5 CGM sensor values for all subjects.
Measured: up to 10 hours
Mean Sensed Glucose
Assess the average sensor glucose based on the Dexcom G5 CGM sensor values.
Measured: up to 10 hours
Number of Carbohydrate Treatments
Assess the average number of carbohydrate treatments per study defined as 15 or 20 grams of carbohydrates.
Measured: up to 10 hours
Mean Amount of Insulin Delivered
Assess the average amount of insulin delivered per study in units/kg.
Measured: up to 10 hours
Mean Score of Visual Analog Scale at 15 Minutes
Assess the average score on the visual analog scale at 15 minutes after insertion of the PDT glucose sensor. This scale will be used to measure sensor site discomfort from the PDT glucose sensing cannula. The subject completes the visual analog scale by drawing a single vertical line through a 100 mm line corresponding to the perceived intensity (severity) of discomfort from the insertion of the sensors. Subjects will be instructed to mark their line starting on the left side over to the right side. If subjects are feeling no discomfort, they would circle the vertical line on the left end of the scale. If subjects are currently feeling the worst discomfort possible, they would circle the vertical line on the right side of the scale. One staff member will measure all scales and document score as a measurement of 0-100.
Measured: 15 minutes post insertion
Mean Score of Visual Analog Scale at 120 Minutes
Assess the average score on the visual analog scale at 120 minutes after insertion of the PDT glucose sensor.This scale will be used to measure sensor site discomfort from the PDT glucose sensing cannula. The subject completes the visual analog scale by drawing a single vertical line through a 100 mm line corresponding to the perceived intensity (severity) of discomfort since the devices were inserted. Subjects will be instructed to mark their line starting on the left side to the right side. If subjects are feeling no discomfort, they would circle the vertical line on the left end of the scale. If subjects are currently feeling the worst discomfort possible, they would circle the vertical line on the right side of the scale. One staff member will measure all scales and document score as a measurement of 0-100.
Measured: 120 minutes post insertion
Mean Score of Visual Analog Scale at End of Study
Assess the average score on the visual analog scale at the end of the study. This scale will be used to measure sensor site discomfort from the PDT glucose sensing cannula. The subject completes the visual analog scale by drawing a single vertical line through a 100 mm line corresponding to the perceived intensity (severity) of discomfort since the devices were inserted. Subjects will be instructed to mark their line starting on the left side to the right side. If subjects are feeling no discomfort, they would circle the vertical line on the left end of the scale. If subjects are currently feeling the worst discomfort possible, they would circle the vertical line on the right side of the scale. One staff member will measure all scales and document score as a measurement of 0-100.
Measured: End of 10 hour study
Mean Draize Scale for Erythema for the Left Sensing Cannula at End of Study for All Subjects
Assess the average score on the Draize scale at the end of the study of the PDT glucose sensor. The investigator discharging the subject will inspect each PDT glucose sensing cannula insertion site and rate the level of redness (erythema) and swelling (edema). Both the left and right insertion sites will be inspected. Erythema will be measured from 0-4. A score of 0 indicates no erythema, a score of 1 indicates very slight, barely perceptible erythema, a score of 2 indicates well defined erythema, a score of 3 indicates moderate erythema, and a score of 4 indicates severe erythema, beet redness to slight eschar formation. Edema will be measured from a score of 0-4. A score of 0 indicates no edema, a score of 1 indicates very slight, barely perceptible edema, a score of 2 indicates well defined edema, a score of 3 indicates moderate edema, raised approximately 1 mm, and a score of 4 indicates severe edema, raised greater than 1 mm and beyond exposure area.
Measured: End of 10 hour study
Mean Draize Scale for Edema for the Left Sensing Cannula at End of Study for All Subjects
Assess the average score on the Draize scale at the end of the study of the PDT glucose sensor. The investigator discharging the subject will inspect each PDT glucose sensing cannula insertion site and rate the level of redness (erythema) and swelling (edema). Both the left and right insertion sites will be inspected. Erythema will be measured from 0-4. A score of 0 indicates no erythema, a score of 1 indicates very slight, barely perceptible erythema, a score of 2 indicates well defined erythema, a score of 3 indicates moderate erythema, and a score of 4 indicates severe erythema, beet redness to slight eschar formation. Edema will be measured from a score of 0-4. A score of 0 indicates no edema, a score of 1 indicates very slight, barely perceptible edema, a score of 2 indicates well defined edema, a score of 3 indicates moderate edema, raised approximately 1 mm, and a score of 4 indicates severe edema, raised greater than 1 mm and beyond exposure area.
Measured: end of 10 hour study
Mean Draize Scale for Erythema for the Right Sensing Cannula at End of Study for All Subjects
Assess the average score on the Draize scale at the end of the study of the PDT glucose sensor. The investigator discharging the subject will inspect each PDT glucose sensing cannula insertion site and rate the level of redness (erythema) and swelling (edema). Both the left and right insertion sites will be inspected. Erythema will be measured from 0-4. A score of 0 indicates no erythema, a score of 1 indicates very slight, barely perceptible erythema, a score of 2 indicates well defined erythema, a score of 3 indicates moderate erythema, and a score of 4 indicates severe erythema, beet redness to slight eschar formation. Edema will be measured from a score of 0-4. A score of 0 indicates no edema, a score of 1 indicates very slight, barely perceptible edema, a score of 2 indicates well defined edema, a score of 3 indicates moderate edema, raised approximately 1 mm, and a score of 4 indicates severe edema, raised greater than 1 mm and beyond exposure area.
Measured: End of 10 hour study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start16 Apr 2018
- Primary completion1 Jul 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 1 Diabetes MellitusStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessica Castle, Oregon Health and Science University
- Investigators
- Jessica Castle, MD, Principal investigator, Oregon Health and Science UniversityPeter Jacobs, PhD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03528174
- Sponsor's protocol ID
- 18241
- Status last verified
- Aug 2019
- First submitted
- 26 Apr 2018
- Last updated
- 12 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of a Novel Sensing Catheter During Automated Insulin Delivery in Patients With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT03528174
- Acronym / sponsor ID
- 18241
- Conditions
- Type 1 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 16 Apr 2018 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 17 May 2018 (actual)
- Results
- Posted 12 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study described within this protocol is designed to test a single hormone closed-loop algorithm for managing blood glucose in type 1 diabetes using insulin only and a new device for measuring glucose continuously in the immediate vicinity of subcutaneous insulin delivery. Subjects will undergo one all day closed loop study using insulin only. The closed loop insulin only system includes a Dexcom G5 transmitter, a Nexus 5 smart phone and two Tandem tslim pumps connected to two Pacific Diabetes Technologies glucose sensing cannulas. The closed loop system will be started after G5 2 hour sensor start-up with an IV catheter for frequent blood withdrawal for 10 hours.
Detailed description
Subjects will undergo one 12 hour inpatient study. During this intervention visit, subjects will wear the single hormone closed loop system which includes two t:slim insulin pumps to deliver insulin or saline through two investigational PDT glucose sensing cannulas, and a Dexcom G5 CGM to measure glucose. The subject will come to the research center at approximately 7am for the inpatient visit. The Dexcom G5 sensor and PDT glucose sensing cannulas will be placed after arrival. An 18-22 gauge IV catheter will be placed for blood sampling every 15 minutes after sensor warm-up is complete for measuring blood glucose concentration. After a 2 hour warm-up period for the G5 sensor, glucose will be controlled using the FMPD single hormone mode. The single hormone mode of the controller determines insulin delivery rates based on proportional and derivative error through one t:slim insulin pump. The second t:slim insulin pump will deliver normal saline at the same delivery rates as the insulin. Subjects will eat breakfast and lunch at approximately 11 am and 3 pm respectively. Subjects will have the ability to complete light exercise on a treadmill. The closed loop system will be stopped at approximately 6pm with removal of all devices.
During the study, the subject will wear one subcutaneous DexcomTM G5 continuous glucose monitoring (CGM) system. The CGM system will provide sensed glucose data every 5 minutes. The accuracy of the sensed data will be obtained by reference measurements of two YSI venous blood glucose values to calibrate the sensor at the beginning of the closed loop study. Sensed glucose data will be wirelessly transmitted via Bluetooth Low Energy (BTLE) from the Dexcom G5 transmitter to the Nexus 5 master controller every five minutes. The controller is a Google Nexus 5 phone. The smart phone will wirelessly communicate via BTLE to two Tandem t:slim insulin pumps, one for automated insulin delivery and one of automated saline delivery.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Hormone closed loop | Experimental | Device: Artificial Pancreas Control system (APC), Device: Pacific Diabetes Technologies CGM Insulin Infusion systemSubjects will have glucose managed using the Artificial Pancreas Control system (APC) using insulin only. Insulin will be infused through the Pacific Diabetes Technologies CGM Insulin Infusion system. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of type 1 diabetes mellitus for at least 1 year.
- Male or female subjects 21 to 65 years of age.
- Current use of an insulin pump for at least 3 months with stable insulin pump settings for > 2 weeks.
- HbA1c ≤ 10% at screening.
- Body Mass Index ≥ 22.
Key exclusion criteria (25 listed)
- Female of childbearing potential who is pregnant or intending to become pregnant or breast-feeding, or is not using adequate contraceptive methods. Acceptable contraception includes birth control pill / patch / vaginal ring, Depo-Provera, Norplant, an IUD, the double barrier method (the woman uses a diaphragm and spermicide and the man uses a condom), or abstinence.
- Any cardiovascular disease, defined as a clinically significant EKG abnormality at the time of screening or any history of: stroke, heart failure, myocardial infarction, angina pectoris, or coronary arterial bypass graft or angioplasty. Diagnosis of 2nd or 3rd degree heart block or any non-physiological arrhythmia judged by the investigator to be exclusionary.
- Renal insufficiency (GFR < 60 ml/min, using the MDRD equation as reported by the OHSU laboratory).
- Liver failure, cirrhosis, or any other liver disease that compromises liver function as determined by the investigator.
- Hematocrit of less than 36% for men, less than 32% for women.
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 |
|---|---|---|
| Artificial Pancreas Control system (APC)This intervention is a single hormone closed loop system including a Nexus 5 smart phone, two tslim insulin pumps, a Dexcom G5 CGM and two PDT glucose sensing cannulas that together make up a new experimental, investigational device system. The algorithm included in the APC is an automated version of the Fading Memory Proportional Derivative (FMPD) insulin and glucagon control algorithm. | Device | Single Hormone closed loop |
| Pacific Diabetes Technologies CGM Insulin Infusion systemAn integrated combination CGM/insulin infusion system | Device | Single Hormone closed loop |
Primary outcome
Mean Absolute Relative Difference of Sensed Glucose Values
Time frame: up to 10 hours
Assess the mean absolute relative difference for the PDT CGM/insulin infusion system based on all reference YSI venous blood glucose values.
13 secondary outcomes
Percent of Time With Sensed Glucose Between 70-180 mg/dl
Time frame: up to 10 hours
Percent of Time With Sensed Glucose Less Than 70 mg/dl
Time frame: up to 10 hours
Percent of Time With Sensed Glucose Less Than 54 mg/dl
Time frame: up to 10 hours
Percent of Time With Sensed Glucose Greater Than 250 mg/dl
Time frame: up to 10 hours
Mean Sensed Glucose
Time frame: up to 10 hours
Number of Carbohydrate Treatments
Time frame: up to 10 hours
Mean Amount of Insulin Delivered
Time frame: up to 10 hours
Mean Score of Visual Analog Scale at 15 Minutes
Time frame: 15 minutes post insertion
Mean Score of Visual Analog Scale at 120 Minutes
Time frame: 120 minutes post insertion
Mean Score of Visual Analog Scale at End of Study
Time frame: End of 10 hour study
Mean Draize Scale for Erythema for the Left Sensing Cannula at End of Study for All Subjects
Time frame: End of 10 hour study
Mean Draize Scale for Edema for the Left Sensing Cannula at End of Study for All Subjects
Time frame: end of 10 hour study
Mean Draize Scale for Erythema for the Right Sensing Cannula at End of Study for All Subjects
Time frame: End of 10 hour study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Jessica Castle, MD principal investigator
Oregon Health and Science University
Peter Jacobs, PhD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pacific Diabetes Technologies CGM Insulin Infusion system in people with Type 1 Diabetes Mellitus, run by Oregon Health and Science 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 8 inclusion and 25 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: finished, as of the sponsor's last update on 12 Sep 2019. 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?
Yes. Results are posted in the registry (first posted 12 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Absolute Relative Difference of Sensed Glucose Values (time frame: up to 10 hours). 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 12 Sep 2019; AzTrials last refreshed its copy on 31 Oct 2026.