A Phase 1 interventional study of Artificial Pancreas Controller in Dual Hormone Mode and Artificial Pancreas Controller in Single Hormone Mode in Type1diabetes, sponsored by Oregon Health and Science University. Completed at 1 site in United States. Open to participants aged 21 Years to 50 Years. Per ClinicalTrials.gov, last updated 2020-05-27.
Sponsored by Oregon Health and Science University · Phase 1, Interventional, and Treatment
Among 38 studies in Motor Activity by Oregon Health and Science University — 1 open to participants now, 3 under way, none of them phase 3. Motor Activity · Oregon Health and Science University.
Among the 38 studies in Motor Activity by Oregon Health and Science University, this one is the 25th largest by enrollment of the 36 interventional ones that give a count, is one of 2 that started in 2018, is the only one in phase 1, and was the 28th registered.
9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.
Browse Motor Activity studies →1 of the 38 studies in Motor Activity by Oregon Health and Science University is open now, in 1 country. Recruiting first, the newest first:
Oregon Health and Science University · Sites in United States
Ages 60–120
By country, each count listing its studies:
Of the 1,201 Motor Activity studies recruiting now, 517 (43%) set no upper age limit and 535 (45%) stop at 75 or younger; 180 take children under 18; 420 take healthy volunteers.
This study: 21 Years to 50 Years · all sexes · no healthy volunteers.
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38 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 4
First in 1999; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 23 is below the median of 60 across 8,388 interventional studies indexed under Motor Activity.
Median enrollment 35 across the 36 interventional studies, 32 across the 2 observational. Of the 32 that completed or were terminated, 10 (31%) have results posted.
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Oregon Health and Science University is the lead sponsor of 696 studies on the registry; 131 are open to participants now.
Of its 52 completed or terminated interventional studies of FDA-regulated products, 39 (75%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 38 studies in Motor Activity by Oregon Health and Science University, from their registry updates:
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Closed-loop systems are an emerging technology that automate hormone delivery. They are quickly paving the way to revolutionize the treatment of type 1 diabetes. Several categories have emerged: dual-hormone (insulin and glucagon) closed-loop systems and closed-loop systems with insulin only, one variety of which is the low glucose suspend safety feature now available from Medtronic (MiniMed640G with SmartGuard). The study described within this protocol is designed to test the efficacy of a new closed-loop algorithm for managing blood glucose in people with type 1 diabetes before and after exercise. The new algorithm will have 3 modes: a single hormone insulin only mode, a dual-hormone insulin and glucagon mode and an insulin only mode with predictive low glucose suspend, all with an exercise detection algorithm. The purpose of this study is to determine whether a dual hormone AP using a stable investigational glucagon with an exercise detection algorithm outperforms both single hormone AP and a low glucose suspend algorithm.
Subjects will undergo three approximately 76 hour studies. During each of these intervention visits, subjects will wear an Omnipod to deliver insulin and a Dexcom G5 CGM to measure glucose. In the dual-hormone closed-loop study, participants will wear a second Omnipod filled with XeriSol™ glucagon. The first day of intervention visit will be a 12 hour inpatient visit with the subsequent time spent as an outpatient. The subject will come back to the research center on Day 4 in the morning to remove all devices. The blood glucose control system is called the Artificial Pancreas Controller (APC). During one of the studies, glucose will be controlled using the dual hormone mode. During another study, glucose will be controlled using the single hormone mode. The single and dual hormone modes of the APC controller determine insulin only and insulin with glucagon delivery rates based on proportional and derivative error and contain an exercise detection component. During the other study, glucose will be controlled using a predictive low glucose suspend (PLGS) mode. In the PLGS mode, the APC will be programmed with the subject's basal profile(s) which will be transmitted to the Omnipod Personal Diabetes Manager (PDM) and allow for boluses to be inputted by the subjects for meals and corrections using their typical carb ratios and correction factors. However, this system will have a safety feature to suspend insulin delivery when sensor glucose is predicted to go below a threshold. Treatment order will be randomized.
Subjects will arrive at the clinic at approximately 7 or 8am for the inpatient visits. Subjects will eat breakfast and lunch at approximately 8:30am, noon and 6pm respectively. The dinner meal will be consumed while the subject is at home. Subjects will exercise on a treadmill for 45 minutes. Subjects will be discharged 9 hours after admission. The subject will then go home for the remainder of the study visit. Studies will be remotely monitored. Subjects will return to OHSU on Day 4 for removal of all devices.
During each 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 capillary blood glucose. 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 for all 3 modes is a Google Nexus 5 phone. The smart phone will wirelessly communicate via BTLE to an Omnipod through a PDM (Insulet Corp. ) for automated insulin delivery or in the case of dual-hormone AP, one used for automated insulin delivery and one for automated glucagon delivery.
A physician or nurse practitioner will be present for study start-up, will be on campus for exercise on Day 1 and will be immediately available on call at all other times.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will undergo a 76 hour study with 9 hours inpatient and 67 hours outpatient using the closed-loop artificial pancreas controller in dual hormone mode and XeriSol glucagon to manage blood sugar that includes an exercise detection component that includes a reduction in insulin delivery and an increase in glucagon delivery upon detection.
Device: Artificial Pancreas Controller in Dual Hormone Mode · Drug: XeriSol glucagon
Subjects will undergo a 76 hour study with 9 hours inpatient and 67 hours outpatient using the closed-loop artificial pancreas controller in single hormone mode to manage blood sugar that includes an exercise detection component that includes a reduction in insulin delivery upon detection.
Device: Artificial Pancreas Controller in Single Hormone Mode
Subjects will undergo a 76 hour study with 9 hours inpatient and 67 hours outpatient using the closed-loop artificial pancreas controller in predictive low glucose suspend mode. The system will run through the closed-loop system but will utilize the patient's optimized basal rates, correction factors and carb ratios as they would normally run on their own insulin pump. But the mode will have the additional safety net of the pump suspending insulin when it predicts a hypoglycemic event.
Device: Artificial Pancreas Controller in Predictive Low Glucose Suspend Mode
The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The algorithm has 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. The Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G5 sensor and sending delivery commands to two Omnipod insulin pumps, one filled with insulin and one with glucagon.
The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. The Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G5 sensor and sending delivery commands to one Omnipod pump filled with insulin.
The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. The Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G5 sensor and sending delivery commands to one Omnipod insulin pump filled with insulin.
XeriSol glucagon is an investigational drug that is a stable, soluble liquid glucagon formulation that can be injected or administered through an insulin pump. XeriSol glucagon will be used to fill the Omnipod to deliver glucagon for the Artificial Pancreas Controller in Dual Hormone mode.
Percent of Time With Sensed Glucose < 70 mg/dl
Assess the percent of time that the Dexcom G5 or G6 reported sensor glucose values less than 70 mg/dl using Dexcom sensor across all three arms.
Time frame: 4 hours post exercise on Day 1
Percent of Time With Sensed Glucose Between 70-180 mg/dl
Assess the percent of time that the Dexcom G5 or G6 reported sensor glucose values between 70-180 mg/dl using Dexcom sensor across all three arms.
Time frame: entire 76 hour study
Number of Carbohydrate Treatments
Assess the number of rescue carbohydrate treatments across all three arms per day.
Time frame: 24 hours
Percent of Time With Sensed Glucose < 54 mg/dl
Assess the percent of time that the Dexcom G5 or G6 reported sensor glucose values less than 54 mg/dl using Dexcom sensor across all three arms.
Time frame: entire 76 hour study
Percent of Time With Sensed Glucose > 180 mg/dl
Assess the percent of time that the Dexcom G5 or G6 reported sensor glucose values greater than 180 mg/dl using Dexcom sensor across all three arms.
Time frame: entire 76 hour study
Mean Amount of Insulin Delivered in One Day
Assess the mean amount of insulin delivered in units/kg as documented through the artificial pancreas controller across all three arms.
Time frame: 24 hours
Mean Amount of Glucagon Delivered in One Day
Assess the mean amount of XeriSol glucagon delivered in mcg/kg as documented through the artificial pancreas controller in dual hormone arm.
Time frame: 24 hours
| Milestone | PLGS-SH-DH | DH-PLGS-SH | SH-DH-PLGS | SH-PLGS-DH | DH-SH-PLGS | PLGS-DH-SH | SH-SH-DH | SH-SH-PLGS-DH | DH-DH-PLGS-SH |
|---|---|---|---|---|---|---|---|---|---|
| Started | 4 | 3 | 3 | 3 | 3 | 4 | 1 | 1 | 1 |
| Completed | 4 | 3 | 3 | 3 | 3 | 4 | 1 | 1 | 1 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | PLGS-SH-DH | DH-PLGS-SH | SH-DH-PLGS | SH-PLGS-DH | DH-SH-PLGS | PLGS-DH-SH | SH-SH-DH | SH-SH-PLGS-DH | DH-DH-PLGS-SH |
|---|---|---|---|---|---|---|---|---|---|
| Started | 4 | 3 | 3 | 3 | 3 | 4 | 1 | 1 | 1 |
| Completed | 4 | 3 | 2 | 3 | 3 | 4 | 1 | 1 | 1 |
| Not completed | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | PLGS-SH-DH | DH-PLGS-SH | SH-DH-PLGS | SH-PLGS-DH | DH-SH-PLGS | PLGS-DH-SH | SH-SH-DH | SH-SH-PLGS-DH | DH-DH-PLGS-SH |
|---|---|---|---|---|---|---|---|---|---|
| Started | 4 | 3 | 2 | 3 | 3 | 4 | 1 | 1 | 1 |
| Completed | 4 | 3 | 2 | 3 | 2 | 4 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 1 | 1 |
| Withdrew: Adverse event | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Device issues | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 |
| Milestone | PLGS-SH-DH | DH-PLGS-SH | SH-DH-PLGS | SH-PLGS-DH | DH-SH-PLGS | PLGS-DH-SH | SH-SH-DH | SH-SH-PLGS-DH | DH-DH-PLGS-SH |
|---|---|---|---|---|---|---|---|---|---|
| Started | 4 | 3 | 2 | 3 | 2 | 4 | 1 | 1 | 1 |
| Completed | 4 | 3 | 2 | 3 | 2 | 4 | 1 | 1 | 1 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | PLGS-SH-DH | DH-PLGS-SH | SH-DH-PLGS | SH-PLGS-DH | DH-SH-PLGS | PLGS-DH-SH | SH-SH-DH | SH-SH-PLGS-DH | DH-DH-PLGS-SH |
|---|---|---|---|---|---|---|---|---|---|
| Started | 4 | 3 | 2 | 3 | 2 | 4 | 1 | 1 | 1 |
| Completed | 4 | 3 | 2 | 3 | 2 | 4 | 1 | 1 | 1 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | PLGS-SH-DH | DH-PLGS-SH | SH-DH-PLGS | SH-PLGS-DH | DH-SH-PLGS | PLGS-DH-SH | SH-SH-DH | SH-SH-PLGS-DH | DH-DH-PLGS-SH |
|---|---|---|---|---|---|---|---|---|---|
| Started | 4 | 3 | 2 | 3 | 2 | 4 | 1 | 1 | 1 |
| Completed | 4 | 3 | 2 | 3 | 2 | 4 | 1 | 1 | 1 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | PLGS-SH-DH | DH-PLGS-SH | SH-DH-PLGS | SH-PLGS-DH | DH-SH-PLGS | PLGS-DH-SH | SH-SH-DH | SH-SH-PLGS-DH | DH-DH-PLGS-SH |
|---|---|---|---|---|---|---|---|---|---|
| Started | 4 | 3 | 2 | 3 | 2 | 4 | 1 | 1 | 1 |
| Completed | 3 | 3 | 2 | 2 | 2 | 4 | 0 | 1 | 1 |
| Not completed | 1 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Adverse event | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Milestone | PLGS-SH-DH | DH-PLGS-SH | SH-DH-PLGS | SH-PLGS-DH | DH-SH-PLGS | PLGS-DH-SH | SH-SH-DH | SH-SH-PLGS-DH | DH-DH-PLGS-SH |
|---|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | PLGS-SH-DH | DH-PLGS-SH | SH-DH-PLGS | SH-PLGS-DH | DH-SH-PLGS | PLGS-DH-SH | SH-SH-DH | SH-SH-PLGS-DH | DH-DH-PLGS-SH |
|---|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Assess the percent of time that the Dexcom G5 or G6 reported sensor glucose values less than 70 mg/dl using Dexcom sensor across all three arms.
| percentage 4 hrs post exercise on Day 1 | Dual Hormone Closed-loop Arm | Single Hormone Closed-loop Arm | Predictive Low Glucose Suspend Arm |
|---|---|---|---|
| Percent of Time With Sensed Glucose < 70 mg/dl | 0 (0 to 4.2) | 8.3 (0 to 12.5) | 4.2 (0 to 9.4) |
Assess the percent of time that the Dexcom G5 or G6 reported sensor glucose values between 70-180 mg/dl using Dexcom sensor across all three arms.
| percentage of 76 hours | Dual Hormone Closed-loop Arm | Single Hormone Closed-loop Arm | Predictive Low Glucose Suspend Arm |
|---|---|---|---|
| Percent of Time With Sensed Glucose Between 70-180 mg/dl | 71.0 ± 9.2 | 72.6 ± 9.2 | 63.4 ± 16.6 |
Assess the number of rescue carbohydrate treatments across all three arms per day.
| number of carbohydrate treatments/day | Dual Hormone Closed-loop Arm | Single Hormone Closed-loop Arm | Predictive Low Glucose Suspend Arm |
|---|---|---|---|
| Number of Carbohydrate Treatments | 0.6 ± 0.9 | 1.7 ± 2.0 | 1.4 ± 1.3 |
Assess the percent of time that the Dexcom G5 or G6 reported sensor glucose values less than 54 mg/dl using Dexcom sensor across all three arms.
| percentage of 76 hours | Dual Hormone Closed-loop Arm | Single Hormone Closed-loop Arm | Predictive Low Glucose Suspend Arm |
|---|---|---|---|
| Percent of Time With Sensed Glucose < 54 mg/dl | 0 (0 to 0.2) | 0.2 (0 to 0.8) | 0.1 (0 to 0.8) |
Assess the percent of time that the Dexcom G5 or G6 reported sensor glucose values greater than 180 mg/dl using Dexcom sensor across all three arms.
| percentage of 76 hours | Dual Hormone Closed-loop Arm | Single Hormone Closed-loop Arm | Predictive Low Glucose Suspend Arm |
|---|---|---|---|
| Percent of Time With Sensed Glucose > 180 mg/dl | 28.2 ± 9.4 | 25.1 ± 9.0 | 34.7 ± 16.7 |
Assess the mean amount of insulin delivered in units/kg as documented through the artificial pancreas controller across all three arms.
| units/kg/day | Dual Hormone Closed-loop Arm | Single Hormone Closed-loop Arm | Predictive Low Glucose Suspend Arm |
|---|---|---|---|
| Mean Amount of Insulin Delivered in One Day | 42.3 ± 16.9 | 41.1 ± 16.4 | 44.0 ± 15.3 |
Assess the mean amount of XeriSol glucagon delivered in mcg/kg as documented through the artificial pancreas controller in dual hormone arm.
| mcg/kg/day | Dual Hormone Closed Loop |
|---|---|
| Mean Amount of Glucagon Delivered in One Day | 4.5 ± 1.9 |
Collected over 13 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dual Hormone Closed-loop Arm | 0/22 (0%) | 0/22 (0%) | 7/22 (31.8%) |
| Single Hormone Closed-loop Arm | 0/21 (0%) | 0/21 (0%) | 3/21 (14.3%) |
| Predictive Low Glucose Suspend Arm | 0/20 (0%) | 0/20 (0%) | 3/20 (15%) |
| Dexcom Training Period Arm | 0/23 (0%) | 0/23 (0%) | 0/23 (0%) |
| Event | Dual Hormone Closed-loop Arm | Single Hormone Closed-loop Arm | Predictive Low Glucose Suspend Arm | Dexcom Training Period Arm |
|---|---|---|---|---|
| GI upsetGastrointestinal disorders | 4/22 | 1/21 | 0/20 | 0/23 |
| Irritation at zephyr siteSkin and subcutaneous tissue disorders | 1/22 | 0/21 | 2/20 | 0/23 |
| headacheNervous system disorders | 2/22 | 0/21 | 0/20 | 0/23 |
| Bruised tailboneMusculoskeletal and connective tissue disorders | 0/22 | 0/21 | 1/20 | 0/23 |
| upper respiratory infectionInfections and infestations | 1/22 | 1/21 | 0/20 | 0/23 |
| Swelling at sensor siteSkin and subcutaneous tissue disorders | 0/22 | 1/21 | 0/20 | 0/23 |
| Burning at glucagon siteSkin and subcutaneous tissue disorders | 1/22 | 0/21 | 0/20 | 0/23 |
| Age, Categorical(Participants) | All Study Participants |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 23 |
| >=65 years | 0 |
| Age, Continuous(years) | All Study Participants |
|---|---|
| Mean | 32.4 ± 7.0 |
| Sex: Female, Male(Participants) | All Study Participants |
|---|---|
| Female | 10 |
| Male | 13 |
| Ethnicity (NIH/OMB)(Participants) | All Study Participants |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 22 |
| Unknown or Not Reported | 1 |
| Race (NIH/OMB)(Participants) | All Study Participants |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 20 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(Participants) | All Study Participants |
|---|---|
| United States | 23 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Mar 2018 to primary completion in May 2019, 13 months.
Results were first posted in May 2020, 11 months after primary completion.
Of 73 non-industry phase 1 interventional studies under Motor Activity, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's 13 months is below that.
Counting every sponsor, half of 75 studies reached it within 20 months; a quarter within 11 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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