Closed-Loop Glucagon Administration For Hypoglycemia Treatment

December 19, 2018 updated by: Steven J. Russell, MD, PhD, Massachusetts General Hospital

Closed-Loop Glucagon Administration for the Automated Prevention and Treatment of Hypoglycemia

This study will test the hypothesis that a wearable automated bionic pancreas system that automatically delivers glucagon only can prevent or treat hypoglycemia vs. usual care for people with type 1 diabetes > 21 years old.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 21 years or older with type 1 diabetes for at least one year.
  • Otherwise healthy (mild chronic disease such as asthma, hypertension, and depression will be allowed if well controlled).
  • Self-reported frequency of documented hypoglycemia (BG < 60 mg/dl) of at least 2 times per week
  • Partial hypoglycemic unawareness (inconsistent symptoms with BG < 50 mg/dl) or hypoglycemic unawareness (minimal or no symptoms with BG < 50 mg/dl)

Exclusion Criteria:

  • Unable to provide informed consent.
  • Unable to comply with study procedures.
  • Current participation in another diabetes-related clinical trial other than one that is primarily observational in nature.
  • Pregnancy (positive urine HCG), breast feeding, plan to become pregnant in the immediate future, or sexually active without use of contraception
  • History of cystic fibrosis, pancreatitis, or other pancreatic disease other than type 1 diabetes
  • End stage renal disease on dialysis (hemodialysis or peritoneal dialysis).
  • Any known liver or biliary disease including cirrhosis, alcoholic liver disease, non-alcoholic fatty liver disease, non-alcoholic steatohepatitis, any form of viral hepatitis.
  • Congestive heart failure (established history of CHF, paroxysmal nocturnal dyspnea, or orthopnea).
  • Acute illness or exacerbation of chronic illness at the time of the study.
  • Seizure disorder or history of hypoglycemic seizure in the last 1 year
  • History of pheochromocytoma. Fractionated metanephrines will be tested in patients with history increasing the risk for a catecholamine secreting tumor:
  • Untreated or inadequately treated mental illness (indicators would include symptoms such as psychosis, hallucinations, mania, and any psychiatric hospitalization in the last year).
  • Current alcohol abuse (intake averaging > 3 drinks daily in last 30 days) or substance abuse (any use within the last 6 months of controlled substances without a prescription).
  • Electrically powered implants (e.g. cochlear implants, neurostimulators) that might be susceptible to RF interference.
  • History of adverse reaction to glucagon (including allergy) besides nausea and vomiting.
  • Unwilling or unable to completely avoid acetaminophen during the study period.
  • Any factors that, in the opinion of the principal investigator, would interfere with the safe completion of the study procedures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Glucagon-only Bionic Pancreas (active)
Glucagon-only Bionic Pancreas will deliver glucagon during 7 of the 14 days. The order of the glucagon days will be randomized in blocks of 2, with no more than 2 days in a row of glucagon.
Device: Glucagon-only Bionic Pancreas
A computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor.
Other Names:
  • Boston University Bionic Pancreas
Placebo Comparator: Glucagon-only Bionic Pancreas (placebo)
Glucagon-only Bionic Pancreas will deliver placebo during 7 of the 14 days. The order of the placebo days will be randomized in blocks of 2, with no more than 2 days in a row of placebo.
Device: Glucagon-only Bionic Pancreas
A computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor.
Other Names:
  • Boston University Bionic Pancreas

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Continuous Glucose Monitor (CGM) Glucose Total Area Over the Curve and Less Than 60 mg/dl
Time Frame: From t=0 to study stop after 2 weeks
From t=0 to study stop after 2 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Time CGM Glucose Less Than 70 mg/dl Overnight and During Daytime
Time Frame: 2 weeks
2 weeks
Number of Hypoglycemic Episodes With CGMG < 50 mg/dl
Time Frame: From t=0 to study stop after 2 weeks
From t=0 to study stop after 2 weeks
Number of Hypoglycemic Episodes With CGMG < 60 mg/dl
Time Frame: from t=0 to study stop after 2 weeks
from t=0 to study stop after 2 weeks
Number of Hypoglycemic Episodes With CGMG < 70 mg/dl
Time Frame: from t=0 to study stop after 2 weeks
from t=0 to study stop after 2 weeks
Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From All CGMG Measurements: < 70 mg/dl,70-120 mg/dl,70-180 mg/dl, >180 mg/dl, >250 mg/dl
Time Frame: from t=0 to stud stop after 2 weeks
from t=0 to stud stop after 2 weeks
Count of Subjects With Mean CGMG < 154mg/dl
Time Frame: from t=0 to study stop after 2 weeks
from t=0 to study stop after 2 weeks
Mean CGMG During Exercise
Time Frame: 2 weeks
Times of exercise were not collected during the study, and therefore this outcome cannot be calculated.
2 weeks
Mean Absolute Relative Deviation (MARD) vs. Subset of BG Measurements Before Meals and at Bedtime
Time Frame: 2 weeks
Blood sugar measurements were not specified as before meals and before bed during the study, so we are unable to calculate and report this outcome.
2 weeks
Mean Absolute Relative Deviation (MARD) Between Capillary Blood Glucose and CGM Glucose Values
Time Frame: from t=0 to study stop after 2 weeks
Paired values between the blood glucose measurements and CGM glucose measurements were compared, and the percent difference was recorded. The mean of the absolute value of all the differences is reported here, and reflects the accuracy of the CGM glucose measurements relative to the capillary blood glucose measurements.
from t=0 to study stop after 2 weeks
Number of Hypoglycemic Events (< 60 mg/dl) as Determined From BG Measurements
Time Frame: from t=0 to study stop after 2 weeks
from t=0 to study stop after 2 weeks
Average BG as Determined From the Measurements Taken Before Meals and Before Bedtime
Time Frame: 2 weeks
Blood sugar measurements were not specified as before meals and before bed during the study, so we are unable to calculate and report this outcome.
2 weeks
Percentage of the BG Values Taken Before Meals and Before Bedimte Less Than 70 mg/dl
Time Frame: 2 weeks
Blood sugar measurements were not specified as before meals and before bed during the study, so we are unable to calculate and report this outcome.
2 weeks
Number of All BG Values Less Than 70 mg/dl
Time Frame: from t=0 to study stop after 2 weeks
from t=0 to study stop after 2 weeks
Number of Study Days With Mean BG < 154 mg/dl
Time Frame: 2 weeks
2 weeks
Fraction Measurements Within Each of the Following Glucose Ranges as Determined From HemoCue Measurements Taken Before Meals and Before Bed: < 70 mg/dl,70-120 mg/dl,70-180 mg/dl,>180 mg/dl,>250 mg/dl
Time Frame: 2 weeks
Blood sugar measurements were not specified as before meals and before bed during the study, so we are unable to calculate and report this outcome.
2 weeks
Mean BG During Exercise
Time Frame: 2 weeks
Times of exercise were not collected during the study, and therefore this outcome cannot be calculated.
2 weeks
• Fraction of BG Values < 70 During Exercise Fraction of BG Values < 70 During Exercise
Time Frame: 2 weeks
Times of exercise were not collected during the study, and therefore this outcome cannot be calculated.
2 weeks
Number of Carbohydrate Interventions for Hypoglycemia
Time Frame: from t=0 to study stop after 2 weeks
from t=0 to study stop after 2 weeks
Total Number of Grams of Carbohydrate Taken for Hypoglycemia
Time Frame: from t=0 to study stop after 2 weeks
from t=0 to study stop after 2 weeks
Insulin Total Daily Dose
Time Frame: from t=0 to study stop after 2 weeks
from t=0 to study stop after 2 weeks
• Number of Carbohydrate Interventions for Hypoglycemia During the Daytime (7:00 AM - 11:00 PM)
Time Frame: 2 weeks
Timing of carbohydrate consumption for treatment of hypoglycemia was not collected during the study, so this outcome cannot be calculated
2 weeks
Total Number of Grams of Carbohydrate Taken for Hypoglycemia During the Daytime (7:00 AM - 11:00 PM)
Time Frame: 2 weeks
Timing of carbohydrate consumption for treatment of hypoglycemia was not collected during the study, so this outcome cannot be calculated
2 weeks
Number of Carbohydrate Interventions for Hypoglycemia Overnight (11:00 PM - 7:00 AM)
Time Frame: 2 weeks
Timing of carbohydrate consumption for treatment of hypoglycemia was not collected during the study, so this outcome cannot be calculated
2 weeks
Total Number of Grams of Carbohydrate Taken for Hypoglycemia Overnight (11:00 PM - 7:00 AM)
Time Frame: 2 weeks
Timing of carbohydrate consumption for treatment of hypoglycemia was not collected during the study, so this outcome cannot be calculated
2 weeks
Total Glucagon Dosing (mcg/kg/24 Hours)
Time Frame: from t=0 to study stop after 2 weeks
from t=0 to study stop after 2 weeks
Episodes of Nausea Per Day on Glucagon vs Placebo
Time Frame: from t=0 to study stop after 2 weeks
from t=0 to study stop after 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Boston University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 9, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 3, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 10, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2013P001663/MGH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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