Type 1 DiabetesNCT02181127
Closed-Loop Glucagon Administration For Hypoglycemia Treatment
A study testing Glucagon-only Bionic Pancreas in people with Type 1 Diabetes, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Glucagon-only Bionic Pancreas
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Apr 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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).
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: 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.
- Conditions
- Type 1 Diabetes
- Being tested
- Glucagon-only Bionic Pancreas
- Keywords
- bionic pancreas, artificial pancreas, insulin, glucagon, continuous glucose monitoring (CGM), outpatient, insulin pump, glucagon pump
- Medical subject headings
- Diabetes Mellitus, Type 1, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucagon-only Bionic PancreasDevice
Also called Boston University Bionic Pancreas
A computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor.
| Study group | Role | What they receive |
|---|---|---|
| Glucagon-only Bionic Pancreas (active) | Active comparator | 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. Receives: Device: Glucagon-only Bionic Pancreas |
| Glucagon-only Bionic Pancreas (placebo) | Placebo comparator | 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. Receives: Device: Glucagon-only Bionic Pancreas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous Glucose Monitor (CGM) Glucose Total Area Over the Curve and Less Than 60 mg/dl
Measured: From t=0 to study stop after 2 weeks
Secondary outcomes (26)
Percentage of Time CGM Glucose Less Than 70 mg/dl Overnight and During Daytime
Measured: 2 weeks
Number of Hypoglycemic Episodes With CGMG < 50 mg/dl
Measured: From t=0 to study stop after 2 weeks
Number of Hypoglycemic Episodes With CGMG < 60 mg/dl
Measured: from t=0 to study stop after 2 weeks
Number of Hypoglycemic Episodes With CGMG < 70 mg/dl
Measured: 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
Measured: from t=0 to stud stop after 2 weeks
Count of Subjects With Mean CGMG < 154mg/dl
Measured: from t=0 to study stop after 2 weeks
Mean CGMG During Exercise
Times of exercise were not collected during the study, and therefore this outcome cannot be calculated.
Measured: 2 weeks
Mean Absolute Relative Deviation (MARD) vs. Subset of BG Measurements Before Meals and at Bedtime
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.
Measured: 2 weeks
Mean Absolute Relative Deviation (MARD) Between Capillary Blood Glucose and CGM Glucose Values
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.
Measured: from t=0 to study stop after 2 weeks
Number of Hypoglycemic Events (< 60 mg/dl) as Determined From BG Measurements
Measured: from t=0 to study stop after 2 weeks
Average BG as Determined From the Measurements Taken Before Meals and Before Bedtime
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.
Measured: 2 weeks
Percentage of the BG Values Taken Before Meals and Before Bedimte Less Than 70 mg/dl
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.
Measured: 2 weeks
Number of All BG Values Less Than 70 mg/dl
Measured: from t=0 to study stop after 2 weeks
Number of Study Days With Mean BG < 154 mg/dl
Measured: 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
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.
Measured: 2 weeks
Mean BG During Exercise
Times of exercise were not collected during the study, and therefore this outcome cannot be calculated.
Measured: 2 weeks
• Fraction of BG Values < 70 During Exercise Fraction of BG Values < 70 During Exercise
Times of exercise were not collected during the study, and therefore this outcome cannot be calculated.
Measured: 2 weeks
Number of Carbohydrate Interventions for Hypoglycemia
Measured: from t=0 to study stop after 2 weeks
Total Number of Grams of Carbohydrate Taken for Hypoglycemia
Measured: from t=0 to study stop after 2 weeks
Insulin Total Daily Dose
Measured: from t=0 to study stop after 2 weeks
• Number of Carbohydrate Interventions for Hypoglycemia During the Daytime (7:00 AM - 11:00 PM)
Timing of carbohydrate consumption for treatment of hypoglycemia was not collected during the study, so this outcome cannot be calculated
Measured: 2 weeks
Total Number of Grams of Carbohydrate Taken for Hypoglycemia During the Daytime (7:00 AM - 11:00 PM)
Timing of carbohydrate consumption for treatment of hypoglycemia was not collected during the study, so this outcome cannot be calculated
Measured: 2 weeks
Number of Carbohydrate Interventions for Hypoglycemia Overnight (11:00 PM - 7:00 AM)
Timing of carbohydrate consumption for treatment of hypoglycemia was not collected during the study, so this outcome cannot be calculated
Measured: 2 weeks
Total Number of Grams of Carbohydrate Taken for Hypoglycemia Overnight (11:00 PM - 7:00 AM)
Timing of carbohydrate consumption for treatment of hypoglycemia was not collected during the study, so this outcome cannot be calculated
Measured: 2 weeks
Total Glucagon Dosing (mcg/kg/24 Hours)
Measured: from t=0 to study stop after 2 weeks
Episodes of Nausea Per Day on Glucagon vs Placebo
Measured: from t=0 to study stop after 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2014 (estimated)
- Study startNov 2014
- Primary completionJun 2015
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Boston University
- Responsible party
- Principal investigator, Steven J. Russell, MD, PhD, Massachusetts General Hospital
- Investigators
- Steven J Russell, MD PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02181127
- Sponsor's protocol ID
- 2013P001663/MGH
- Status last verified
- Dec 2018
- First submitted
- 9 Sep 2013
- Last updated
- 10 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closed-Loop Glucagon Administration for the Automated Prevention and Treatment of Hypoglycemia
- ClinicalTrials.gov ID
- NCT02181127
- Acronym / sponsor ID
- 2013P001663/MGH
- Conditions
- Type 1 Diabetes
- Keywords
- bionic pancreas, artificial pancreas, insulin, glucagon, continuous glucose monitoring (CGM), outpatient, insulin pump, glucagon pump
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Boston University
- Study start
- Nov 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 3 Jul 2014 (estimated)
- Results
- Posted 26 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glucagon-only Bionic Pancreas (active) | Active comparator | Device: Glucagon-only Bionic PancreasGlucagon-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. |
| Glucagon-only Bionic Pancreas (placebo) | Placebo comparator | Device: Glucagon-only Bionic PancreasGlucagon-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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glucagon-only Bionic PancreasAlso: Boston University Bionic PancreasA computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor. | Device | Glucagon-only Bionic Pancreas (active), Glucagon-only Bionic Pancreas (placebo) |
Primary outcome
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
26 secondary outcomes
Percentage of Time CGM Glucose Less Than 70 mg/dl Overnight and During Daytime
Time frame: 2 weeks
Number of Hypoglycemic Episodes With CGMG < 50 mg/dl
Time frame: 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
Number of Hypoglycemic Episodes With CGMG < 70 mg/dl
Time frame: 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
Count of Subjects With Mean CGMG < 154mg/dl
Time frame: from t=0 to study stop after 2 weeks
Mean CGMG During Exercise
Time frame: 2 weeks
Mean Absolute Relative Deviation (MARD) vs. Subset of BG Measurements Before Meals and at Bedtime
Time frame: 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
Number of Hypoglycemic Events (< 60 mg/dl) as Determined From BG Measurements
Time frame: 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
Percentage of the BG Values Taken Before Meals and Before Bedimte Less Than 70 mg/dl
Time frame: 2 weeks
Number of All BG Values Less Than 70 mg/dl
Time frame: from t=0 to study stop after 2 weeks
Number of Study Days With Mean BG < 154 mg/dl
Time frame: 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
Mean BG During Exercise
Time frame: 2 weeks
• Fraction of BG Values < 70 During Exercise Fraction of BG Values < 70 During Exercise
Time frame: 2 weeks
Number of Carbohydrate Interventions for Hypoglycemia
Time frame: 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
Insulin Total Daily Dose
Time frame: 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
Total Number of Grams of Carbohydrate Taken for Hypoglycemia During the Daytime (7:00 AM - 11:00 PM)
Time frame: 2 weeks
Number of Carbohydrate Interventions for Hypoglycemia Overnight (11:00 PM - 7:00 AM)
Time frame: 2 weeks
Total Number of Grams of Carbohydrate Taken for Hypoglycemia Overnight (11:00 PM - 7:00 AM)
Time frame: 2 weeks
Total Glucagon Dosing (mcg/kg/24 Hours)
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Information about this and related studiesLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven J Russell, MD PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucagon-only Bionic Pancreas in people with Type 1 Diabetes, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2019.