Primary outcomeMean· up to 10 hours
Mean Absolute Relative Difference of Sensed Glucose Values
| Group | Value (percentage of reference blood glucose) | Spread |
|---|---|---|
| Single Hormone Closed Loop | 13.5 | 4.6 |
Trial · Interventional
CompletedNot applicableResults postedRegistry dataSingle Hormone Closed Loop Study With PDT Sensor
NCTNCT03528174 (opens ClinicalTrials.gov in a new tab)Other id18241
This trial does not test a peptide that PepBank tracks.
- Names Glucagon, does not test it. It appears in the description.
Overview
- Status
- Completed
- Phase
- Not applicable
- Enrollment
- 10 participants (actual)
- Sponsor
- Oregon Health and Science University · Other
- Design
- Allocation not applicable · Open label (no masking)
- Countries
1 country
United States
- Start
- 16 Apr 2018
- Primary completion
- 1 Jul 2018
- Completion
- 1 Jul 2018
- First posted
- 17 May 2018
- Last update posted
- 12 Sept 2019
- Conditions
- Type 1 Diabetes Mellitus
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
20182019
- N/A
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- Artificial Pancreas Control system (APC)Device
- Pacific Diabetes Technologies CGM Insulin Infusion systemDevice
Arms1
Experimental
Single Hormone closed loop
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.
Primary outcomes1
Outcomes the sponsor listed as primary.
Mean Absolute Relative Difference of Sensed Glucose Values
Time frame · up to 10 hours
Registry description
Assess the mean absolute relative difference for the PDT CGM/insulin infusion system based on all reference YSI venous blood glucose values.
Secondary outcomes(13)
Percent of Time With Sensed Glucose Between 70-180 mg/dl
Time frame · up to 10 hours
Registry description
Assess the percent of time with sensed glucose between 70-180 mg/dl based on the Dexcom G5 CGM sensor values for all subjects.
Percent of Time With Sensed Glucose Less Than 70 mg/dl
Time frame · up to 10 hours
Registry description
Assess the percent of time with sensed glucose less than 70 mg/dl based on the Dexcom G5 CGM sensor values for all subjects.
Percent of Time With Sensed Glucose Less Than 54 mg/dl
Time frame · up to 10 hours
Registry description
Assess the percent of time with sensed glucose less than 54 mg/dl based on the Dexcom G5 CGM sensor values for all subjects.
Percent of Time With Sensed Glucose Greater Than 250 mg/dl
Time frame · up to 10 hours
Registry description
Assess the percent of time with sensed glucose greater than 250 mg/dl based on the Dexcom G5 CGM sensor values for all subjects.
Mean Sensed Glucose
Time frame · up to 10 hours
Registry description
Assess the average sensor glucose based on the Dexcom G5 CGM sensor values.
Number of Carbohydrate Treatments
Time frame · up to 10 hours
Registry description
Assess the average number of carbohydrate treatments per study defined as 15 or 20 grams of carbohydrates.
Mean Amount of Insulin Delivered
Time frame · up to 10 hours
Registry description
Assess the average amount of insulin delivered per study in units/kg.
Mean Score of Visual Analog Scale at 15 Minutes
Time frame · 15 minutes post insertion
Registry description
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.
Mean Score of Visual Analog Scale at 120 Minutes
Time frame · 120 minutes post insertion
Registry description
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.
Mean Score of Visual Analog Scale at End of Study
Time frame · End of 10 hour study
Registry description
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.
Mean Draize Scale for Erythema for the Left Sensing Cannula at End of Study for All Subjects
Time frame · End of 10 hour study
Registry description
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.
Mean Draize Scale for Edema for the Left Sensing Cannula at End of Study for All Subjects
Time frame · end of 10 hour study
Registry description
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.
Mean Draize Scale for Erythema for the Right Sensing Cannula at End of Study for All Subjects
Time frame · End of 10 hour study
Registry description
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.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcomeMean· up to 10 hours
Percent of Time With Sensed Glucose Between 70-180 mg/dl
| Group | Value (percentage of time) | Spread |
|---|---|---|
| Single Hormone Closed Loop | 59.8 | 27.42 |
Secondary outcomeMean· up to 10 hours
Percent of Time With Sensed Glucose Less Than 70 mg/dl
| Group | Value (percentage of time) | Spread |
|---|---|---|
| Single Hormone Closed Loop | 3.3 | 7 |
Secondary outcomeMean· up to 10 hours
Percent of Time With Sensed Glucose Less Than 54 mg/dl
| Group | Value (percentage of time) | Spread |
|---|---|---|
| Single Hormone Closed Loop | 0.3 | 0.7 |
Secondary outcomeMean· up to 10 hours
Percent of Time With Sensed Glucose Greater Than 250 mg/dl
| Group | Value (percentage of time) | Spread |
|---|---|---|
| Single Hormone Closed Loop | 12.4 | 17.7 |
Secondary outcomeMean· up to 10 hours
Mean Sensed Glucose
| Group | Value (mg/dL) | Spread |
|---|---|---|
| Single Hormone Closed Loop | 167.8 | 71 |
Secondary outcomeMean· up to 10 hours
Number of Carbohydrate Treatments
| Group | Value (carbohydrate treatments) | Spread |
|---|---|---|
| Single Hormone Closed Loop | 0.6 | 1.9 |
Secondary outcomeMean· up to 10 hours
Mean Amount of Insulin Delivered
| Group | Value (units/kg) | Spread |
|---|---|---|
| Single Hormone Closed Loop | 0.24 | 0.11 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Single Hormone Closed LoopSubjects 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. 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. Pacific Diabetes Technologies CGM Insulin Infusion system: An integrated combination CGM/insulin infusion system | 0 / 10 | 1 / 10 | 0 / 10 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 21 Years up to 65 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
* 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.
PepBank is a research reference. Talk to a doctor before you use any peptide.