Skip to content

Trial · Interventional

CompletedNot applicableResults postedRegistry data

Four Way Crossover Closed Loop With Exercise Detection

This trial does not test a peptide that PepBank tracks.

  • Measures Glucagon, does not give it. It appears in an outcome measure.

Overview

Status
Completed
Phase
Not applicable
Enrollment
25 participants (actual)
Sponsor
Oregon Health and Science University · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Oct 2016
Primary completion
Aug 2017
Completion
31 Jan 2018
First posted
11 Aug 2016 (estimated)
Last update posted
14 Sept 2018
Conditions
Type 1 Diabetes

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2016201720182019
  1. N/A

    Four Way Crossover Closed Loop With Exercise Detection

    NCT02862730

    Oct 2016 to 31 Jan 2018

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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 (MiniMed 530G with Enlite). 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 with an exercise detection algorithm outperforms both single hormone AP and a low glucose suspend algorithm and sensor augmented pump therapy using the subject's own insulin pump.

Interventions

  • Artificial Pancreas Controller in Dual Hormone ModeDevice
  • Subject's insulin pumpDevice
  • Artificial Pancreas Controller in Single Hormone ModeDevice
  • Artificial Pancreas Controller in Predictive Low Glucose Suspend ModeDevice

Arms4

  • Experimental

    Predictive Low Glucose Suspend Arm

    Subjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient. The predictive low glucose suspend system will run through the artificial pancreas controller in predictive low glucose suspend mode and utilize the patient's optimized basal rates, correction factor, and carb ratio, but it will have the additional safety net of the pump suspending insulin when it predicts a hypoglycemic event.

  • Experimental

    Dual Hormone Closed-loop Arm

    Subjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient using the closed-loop artificial pancreas controller in dual hormone mode 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.

  • Experimental

    Single Hormone Closed-loop Arm

    Subjects will undergo an 84 hour study with 24 hours inpatient and 60 hour 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.

  • Active comparator

    Sensor Augmented Pump Therapy arm

    Subjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient with subject's insulin pump and glucose sensor, if he/she typically uses one. Subjects will still wear a heart rate monitor uploading to a smart phone.

Primary outcomes4

Outcomes the sponsor listed as primary.

  1. Percent of Time With Sensed Glucose < 3.9 mmol/L

    Time frame · entire 84 hour study

    Registry description

    Assess the percent of time that the Dexcom G4 Share reported sensor glucose values less than 3.9 mmol/L using Dexcom sensor downloads across all four arms.

  2. Percent of Time With Sensed Glucose < 3.9 mmol/L

    Time frame · From 14:00-18:00 for each 12 hour inpatient visit

    Registry description

    Assess the percent of time that the Dexcom G4 Share reported sensor glucose values less than 3.9 mmol/L using Dexcom sensor downloads across all four arms.

  3. Percent of Time With Sensed Glucose Between 3.9-10 mmol/L

    Time frame · entire 84 hour study

    Registry description

    Assess the percent of time that the Dexcom G4 Share reported sensor glucose values between 3.9-10 mmol/L using Dexcom sensor downloads across all four arms.

  4. Percent of Time With Sensed Glucose Between 3.9-10 mmol/L

    Time frame · From 14:00-18:00 for each 12 hour inpatient visit

    Registry description

    Assess the percent of time that the Dexcom G4 Share reported sensor glucose values between 3.9-10 mmol/L using Dexcom sensor downloads across all four arms.

Secondary outcomes(8)
  1. Mean Sensed Glucose

    Time frame · entire 84 hour study

    Registry description

    Assess the mean sensor glucose using Dexcom sensor downloads across all four arms.

  2. Number of Carbohydrate Treatments

    Time frame · entire 84 hour study

    Registry description

    Assess the number of rescue carbohydrate treatments per day across all four arms.

  3. Percent of Time With Sensed Glucose < 3.0 mmol/L

    Time frame · entire 84 hour study

    Registry description

    Assess the percent of time that the Dexcom G4 Share reported sensor glucose values less than 3.0 mmol/L using Dexcom sensor downloads across all four arms.

  4. Percent of Time With Sensed Glucose > 10 mmol/L

    Time frame · entire 84 hour study

    Registry description

    Assess the percent of time that the Dexcom G4 Share reported sensor glucose values greater than 10 mmol/L using Dexcom sensor downloads across all four arms

  5. Number of Events With Capillary Blood Glucose < 3.9 mmol/L

    Time frame · entire 84 hour study

    Registry description

    Assess number of events with capillary blood glucose \< 3.9 mmol/L using downloads from a Contour Next blood glucose meter across all four arms. .

  6. Number of Events With Capillary Blood Glucose < 3.0 mmol/L

    Time frame · entire 84 hour study

    Registry description

    Assess number of events with capillary blood glucose \< 3.0 mmol/L using downloads from a Contour Next blood glucose meter across all four arms.

  7. Mean Amount of Insulin Delivered

    Time frame · 24 hours

    Registry description

    Assess the average amount of insulin delivered per day in units/kg as documented through the artificial pancreas controller across all four arms.

  8. Mean Amount of Glucagon Delivered

    Time frame · 24 hours

    Registry description

    Assess the average amount of insulin delivered per day in units/kg as documented through the artificial pancreas controller in dual hormone arm.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· entire 84 hour study

Percent of Time With Sensed Glucose < 3.9 mmol/L

GroupValue (percentage of 84 hours)Spread
Predictive Low Glucose Suspend Arm1.81.5
Dual Hormone Closed-loop Arm1.21.0
Single Hormone Closed-loop Arm2.71.7
Sensor Augmented Pump Therapy Arm3.03.1
Primary outcomeMean· From 14:00-18:00 for each 12 hour inpatient visit

Percent of Time With Sensed Glucose < 3.9 mmol/L

GroupValue (percentage of 4 hours after exercise)Spread
Predictive Low Glucose Suspend Arm6.98.0
Dual Hormone Closed-loop Arm3.54.9
Single Hormone Closed-loop Arm7.512.2
Sensor Augmented Pump Therapy Arm4.06.6
Primary outcomeMean· entire 84 hour study

Percent of Time With Sensed Glucose Between 3.9-10 mmol/L

GroupValue (percentage of 84 hours)Spread
Predictive Low Glucose Suspend Arm62.914.5
Dual Hormone Closed-loop Arm72.710.5
Single Hormone Closed-loop Arm75.68.7
Sensor Augmented Pump Therapy Arm63.117.6
Primary outcomeMean· From 14:00-18:00 for each 12 hour inpatient visit

Percent of Time With Sensed Glucose Between 3.9-10 mmol/L

GroupValue (percentage of 4 hours after exercise)Spread
Predictive Low Glucose Suspend Arm78.020.1
Dual Hormone Closed-loop Arm84.616.1
Single Hormone Closed-loop Arm84.416.3
Sensor Augmented Pump Therapy Arm79.425.3
Secondary and other outcome results(4)
Secondary outcomeMean· entire 84 hour study

Mean Sensed Glucose

GroupValue (mg/dL)Spread
Predictive Low Glucose Suspend Arm165.921.8
Dual Hormone Closed-loop Arm154.115.8
Single Hormone Closed-loop Arm146.812
Sensor Augmented Pump Therapy Arm161.929
Secondary outcomeMean· entire 84 hour study

Number of Carbohydrate Treatments

GroupValue (number of carbohydrate treatments/day)Spread
Predictive Low Glucose Suspend Arm1.31.3
Dual Hormone Closed-loop Arm0.80.7
Single Hormone Closed-loop Arm1.61.4
Sensor Augmented Pump Therapy Arm1.41.2
Secondary outcomeMean· entire 84 hour study

Percent of Time With Sensed Glucose < 3.0 mmol/L

GroupValue (percentage of 84 hours)Spread
Predictive Low Glucose Suspend Arm0.20.3
Dual Hormone Closed-loop Arm0.20.4
Single Hormone Closed-loop Arm0.60.6
Sensor Augmented Pump Therapy Arm0.30.6
Secondary outcomeMean· entire 84 hour study

Percent of Time With Sensed Glucose > 10 mmol/L

GroupValue (percentage of 84 hours)Spread
Predictive Low Glucose Suspend Arm35.215.1
Dual Hormone Closed-loop Arm26.110.9
Single Hormone Closed-loop Arm21.79.1
Sensor Augmented Pump Therapy Arm33.918.2

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Predictive Low Glucose Suspend ArmArtificial 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 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. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin.0 / 230 / 235 / 23
Dual Hormone Closed-loop ArmArtificial Pancreas Controller in Dual Hormone 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 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. Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon.0 / 220 / 228 / 22
Single Hormone Closed-loop ArmArtificial Pancreas Controller in Single Hormone 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 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. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin.0 / 220 / 222 / 22
Sensor Augmented Pump Therapy ArmSubjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient with subject's insulin pump and glucose sensor, if he/she typically uses one. Subjects will still wear a heart rate monitor uploading to a smart phone. Subject's insulin pump: Subject will continue on their subcutaneous delivery of insulin on his/her own insulin pump using their own basal rates and carb ratios for meal boluses, managing their blood sugar as they normally would.0 / 220 / 223 / 22
Tslim TrainingSubjects used the tslim and Dexcom G4 Share of G5 sensor for two weeks at home to allow subjects to become familiar with the devices.0 / 250 / 252 / 25

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.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedCastle JR, El Youssef J, Wilson LM, Reddy R, Resalat N, Branigan D, Ramsey K, Leitschuh J, Rajhbeharrysingh U, Senf B, Sugerman SM, Gabo V, Jacobs PG. Randomized Outpatient Trial of Single- and Dual-Hormone Closed-Loop Systems That Adapt to Exercise Using Wearable Sensors. Diabetes Care. 2018 Jul;41(7):1471-1477. doi: 10.2337/dc18-0228. Epub 2018 May 11. PMID 29752345

Eligibility

Who could join, as posted.

Sex
All
Age
from 21 Years up to 45 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Diagnosis of type 1 diabetes mellitus for at least 1 year. * Physically willing and able to perform 45 min of exercise (as determined by the investigator after reviewing the subjects activity level) * Current use of an insulin pump. * Lives with another person age 18 or older who will be present while subject exercises at home and that can attend the training on using the system with the subject. * Lives within 20 miles of OHSU. * A1C\<10% * 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 report 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 or equal to 34%. * Hypertensive subjects with systolic blood pressure \>= 160 mmHg or diastolic blood pressure \>= 100 mmHg despite treatment or who have treatment-refractory hypertension (e.g. requiring four or more medications). * History of severe hypoglycemia during the past 12 months prior to screening visit or hypoglycemia unawareness as judged by the investigator. Subjects will complete a hypoglycemia awareness questionnaire. Subjects will be excluded for four or more R responses. * 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 aspart insulin. * Allergy to glucagon. * Insulin resistance requiring more than 200 units per day. * 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). * Diagnosis of pheochromocytoma, insulinoma, or glucagonoma, personal or family history of multiple endocrine neoplasia (MEN) 2A, MEN 2B, neurofibromatosis or von Hippel-Lindau disease. * History of severe hypersensitivity to milk protein. * Current use of any medication with strong anticholinergic properties, such as antihistamines, sleep aids, and antidiarrheal medications. * Current use of indomethacin. * Conditions that may result in low levels of releasable glucose in the liver and an inadequate reversal of hypoglycemia by glucagon such as prolonged fasting, starvation or chronic hypoglycemia as determined by the investigator. * A positive response to any of the questions from the Physical Activity Readiness Questionnaire. * Any chest discomfort with physical activity, including pain or pressure, or other types of discomfort. * 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.