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Trial · Interventional

CompletedNot applicableResults postedRegistry data

Three-way, Cross-over Closed-loop Exercise Study

NCTNCT02241889 (opens ClinicalTrials.gov in a new tab)Other idDP3-2014
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Measures Glucagon, does not give it. It appears in the eligibility rules.

Overview

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

United States

Start
Jan 2015
Primary completion
Sept 2015
Completion
Sept 2015
First posted
16 Sept 2014 (estimated)
Last update posted
22 May 2017
Conditions
Type 1 Diabetes

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20152016
  1. N/A

    Three-way, Cross-over Closed-loop Exercise Study

    NCT02241889

    Jan 2015 to Sept 2015

Registry summary

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

Blood glucose control systems that utilize both insulin and glucagon to manage blood sugar are paving the way to revolutionize the management of this disease. The benefit of improved control of blood sugar levels compared to standard insulin pump therapy has already been demonstrated. However, the risk of low blood sugar in type 1 diabetes increases considerably during exercise. The investigators research group has shown that small doses of glucagon can prevent low blood sugar when used in a blood sugar control system in patients with type 1 diabetes. However, as insulin sensitivity changes occur very rapidly during exercise, the ability to recognize the onset of physical activity in order to appropriately adjust the insulin and glucagon delivery is vital to helping prevent exercise-induced hypoglycemia. The purpose of this study is to test how well a new modified blood sugar control system controls blood sugar during exercise compared to: 1) the current system without modifications and 2) standard insulin pump therapy.

Interventions

  • Insulin pump therapyDevice
  • Closed-loop Artificial Pancreas ControllerDevice

Arms3

  • Active comparator

    Standard Insulin Pump Therapy

    Subjects will undergo 21 hour study with exercise using Insulin pump therapy and managing their blood glucose as they normally would.

  • Experimental

    Closed-loop without adjustment

    Subjects will undergo 21 study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will not be annouced to the controller and no adjustments to insulin and glucagon delivery will be made.

  • Experimental

    Closed-loop with adjustment

    Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will be annouced to the controller and adjustments to insulin and glucagon delivery will be made.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Percent of Time With Sensed Glucose < 70 mg/dl

    Time frame · from start of exercise (~hour 12) until study completion (hour 21)

    Registry description

    Assess the percent of time that the Dexcom G4 or G4 Share reported sensor glucose values less than 70 mg/dl using Dexcom sensor downloads.

  2. Percent of Time With Sensed Glucose Between 70-180 mg/dl

    Time frame · from start of exercise (~hour 12) until study completion (hour 21)

    Registry description

    Assess the percent of time that the Dexcom G4 or G4 Share reported sensor glucose values between 70-180 mg/dl using Dexcom sensor downloads.

Secondary outcomes(8)

  1. Mean of the Mean Sensed Glucose Per Participant

    Time frame · Entire 21 hour study duration excluding the first four hours

    Registry description

    Assess the mean sensed glucose per participant using Dexcom sensor downloads.

  2. Number of Carbohydrate Treatments

    Time frame · Entire 21 hour study duration excluding the first four hours

    Registry description

    Assess the number of rescue carbohydrate treatments.

  3. Percent of Time With Sensed Glucose < 50 mg/dl

    Time frame · Entire 21 hour study duration excluding the first four hours

    Registry description

    Assess the percent of time that the Dexcom G4 or G4 Share reported sensor glucose values less than 50 mg/dl using Dexcom sensor downloads.

  4. Percent of Time With Sensed Glucose > 180 mg/dl

    Time frame · Entire 21 hour study duration excluding the first four hours

    Registry description

    Assess the percent of time that the Dexcom G4 or G4 Share reported sensor glucose values greater than 180 mg/dl using Dexcom sensor downloads.

  5. Number of Events Capillary Blood Glucose (CBG) <70 mg/dl

    Time frame · Entire 21 hour study duration excluding the first four hours

    Registry description

    Number of events measured with capillary blood glucose \<70 mg/dl.

  6. Number of Events With CBG Between 70 - 180 mg/dl

    Time frame · Entire 21 hour study duration excluding the first four hours

    Registry description

    Assess the number of events that the Contour Next BG meter reported blood glucose values between 70-180 mg/dl using meter downloads.

  7. Number of Events With CBG <50 mg/dl

    Time frame · Entire 21 hour study duration excluding the first four hours

    Registry description

    Assess the total number of events that the Contour Next BG meter reported blood glucose values less than 50 mg/dl across all participants in each group.

  8. Percent of Time of CBG>180 mg/dl

    Time frame · Entire 21 hour study duration excluding the first four hours

    Registry description

    Assess the percent of time that the Contour Next BG meter reported blood glucose values greater than 180 mg/dl using meter downloads.

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· from start of exercise (~hour 12) until study completion (hour 21)

Percent of Time With Sensed Glucose < 70 mg/dl

GroupValue (percentage of time)
Standard Insulin Pump Therapy0.9
Closed-loop Without Adjustment3.2
Closed-loop With Adjustment0.3
Primary outcomeMean· from start of exercise (~hour 12) until study completion (hour 21)

Percent of Time With Sensed Glucose Between 70-180 mg/dl

GroupValue (percent of time)
Standard Insulin Pump Therapy67.6
Closed-loop Without Adjustment72.5
Closed-loop With Adjustment67.3
Secondary and other outcome results(6)
Secondary outcomeMean· Entire 21 hour study duration excluding the first four hours

Mean of the Mean Sensed Glucose Per Participant

GroupValue (mg/dl)
Standard Insulin Pump Therapy8.6
Closed-loop Without Adjustment8.0
Closed-loop With Adjustment8.6
Secondary outcomeMean· Entire 21 hour study duration excluding the first four hours

Number of Carbohydrate Treatments

GroupValue (carbohydrate treatments)
Standard Insulin Pump Therapy0.33
Closed-loop Without Adjustment0.43
Closed-loop With Adjustment0.29
Secondary outcomeMean· Entire 21 hour study duration excluding the first four hours

Percent of Time With Sensed Glucose < 50 mg/dl

GroupValue (percent of time)
Standard Insulin Pump Therapy0.001
Closed-loop Without Adjustment0.001
Closed-loop With Adjustment0.0
Secondary outcomeMean· Entire 21 hour study duration excluding the first four hours

Percent of Time With Sensed Glucose > 180 mg/dl

GroupValue (percent of time)
Standard Insulin Pump Therapy26.9
Closed-loop Without Adjustment16.9
Closed-loop With Adjustment25.2
Secondary outcomeMean· Entire 21 hour study duration excluding the first four hours

Number of Events Capillary Blood Glucose (CBG) <70 mg/dl

GroupValue (occurrences of blood glucose < 70 mg/dl)
Standard Insulin Pump Therapy0.43
Closed-loop Without Adjustment0.33
Closed-loop With Adjustment0.24
Secondary outcomeMean· Entire 21 hour study duration excluding the first four hours

Number of Events With CBG Between 70 - 180 mg/dl

GroupValue (# of events)
Standard Insulin Pump Therapy1.6
Closed-loop Without Adjustment3.1
Closed-loop With Adjustment3.0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Standard Insulin Pump TherapySubjects will undergo 21 hour study with exercise using Insulin pump therapy and managing their blood glucose as they normally would. Insulin pump therapy: Subject's own insulin pump will be used to manage blood glucose.0 / 230 / 231 / 23
Closed-loop Without AdjustmentSubjects will undergo 21 study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will not be annouced to the controller and no adjustments to insulin and glucagon delivery will be made. Closed-loop Artificial Pancreas Controller: 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 / 230 / 233 / 23
Closed-loop With AdjustmentSubjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will be annouced to the controller and adjustments to insulin and glucagon delivery will be made. Closed-loop Artificial Pancreas Controller: 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 / 230 / 233 / 23

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 45 Years
Healthy volunteers
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 45 years of age. * 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. * 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). * Impaired liver function, defined as AST or ALT ≥2.5 times upper limit of normal, according to OHSU laboratory reference ranges. * Hematocrit of less than or equal to 34%. * History of severe hypoglycemia during the past 12 months prior to screening visit or hypoglycemia unawareness 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 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). * C peptide level of ≥0.5 ng/ml * Any concurrent illness, other than diabetes, that is not controlled by a stable therapeutic regimen. * Beta blockers or non-dihydropyridine calcium channel blockers. * A positive response to any of the questions from the Physical Activity Readiness Questionnaire. * Any clinically significant disease or disorder which in the opinion of the Investigator may jeopardize the subject's safety or compliance with the protocol.

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