HypoglycemiaNCT02966275
Post Bariatric Closed Loop Glucagon Trial
A study testing Glucagon-only bionic pancreas - glucagon in people with Hypoglycemia, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This study is to test our automated hypoglycemia prevention and treatment device (glucagon-only bionic pancreas) in subjects that have undergone post-bariatric surgery that are experiencing symptoms of hypoglycemia. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypoglycemia
- What is being tested?
- Glucagon-only bionic pancreas - glucagon
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Dec 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 a gastric bypass for more than 1 year.
- Post-bariatric hypoglycemia with prior episodes of neuroglycopenia, unresponsive to dietary intervention (low glycemic index, controlled carbohydrate portions) and trial of acarbose therapy at the maximally tolerated dose. Other therapies will not exclude a subject as long as the therapy is continued during the study.
- 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 verified by capillary blood glucose measurements) of at least 2 times per week.
Who cannot join
- Unable to provide informed consent.
- Unable to comply with study procedures.
- Current participation in another hypoglycemia 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.
- Use of insulin and/or insulin secretogues as sulfonylurea, metglitides, and glitazones.
- History of cystic fibrosis, pancreatitis, type 1 diabetes or other pancreatic disease.
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- 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.
- Known insulinoma or predominantly fasting pattern of hypoglycemia
- Adrenal insufficiency. Congenital hyperinsulinemia presenting with hypoglycemia during infancy.
- History of pheochromocytoma. Fractionated metanephrines will be tested in patients with history increasing the risk for a catecholamine secreting tumor:
- Paroxysms of tachycardia, pallor, or headache.
- Personal or family history of MEN 2A, MEN 2B, neurofibromatosis, or von Hippel-Lindau disease.
- Episodic or treatment refractory (requiring 4 or more medications to achieve normotension) hypertension.
- Untreated or inadequately treated mental illness (indicators would include symptoms such as psychosis, hallucinations, mania, and/or 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).
- Unwilling or unable to refrain from drinking more than two drinks in an hour or more than four drinks in a day during the trial.
- 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 Treatment Of Post-Bariatric Hypoglycemia
This study is to test our automated hypoglycemia prevention and treatment device (glucagon-only bionic pancreas) in subjects that have undergone post-bariatric surgery that are experiencing symptoms of hypoglycemia.
- Conditions
- Hypoglycemia
- Being tested
- Glucagon-only bionic pancreas - glucagon, Glucagon-only bionic pancreas - placebo
- Keywords
- glucagon, continuous glucose monitorering (CGM), artificial pancreas, hypoglycemia, post-bariatric hypoglycemia, bionic pancreas, bariatric surgery
- Medical subject headings
- Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucagon-only bionic pancreas - glucagonDevice
A computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor.
Glucagon-only bionic pancreas - placeboDevice
A computer algorithm will automatically deliver placebo based on the signal from a minimally invasive continuous glucose monitor.
| Study group | Role | What they receive |
|---|---|---|
| Glucagon-only bionic pancreas - glucagon | Experimental | Subjects will wear the bionic pancreas that consists of a continuous glucose monitor linked to a smartphone running a hypoglycemia prevention algorithm that doses glucagon from an insulin pump through a subcutaneous infusion set.
Subjects will continue to manage any hypoglycemia that occurs according to the current recommendations of their care provider. Receives: Device: Glucagon-only bionic pancreas - glucagon |
| Glucagon-only bionic pancreas - placebo | Placebo comparator | Subjects will wear the bionic pancreas that consists of a continuous glucose monitor linked to a smartphone running a hypoglycemia prevention algorithm that doses placebo from an insulin pump through a subcutaneous infusion set.
Subjects will continue to manage any hypoglycemia that occurs according to the current recommendations of their care provider. Receives: Device: Glucagon-only bionic pancreas - placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Over the Curve and <60 mg/dl (CGM) Measured in mg/dl *Min
The measure for area over the curve is used when an integrated assessment (e.g., a measurement of something over a specific amount of time) is more useful in understanding a phenomenon. To calculate this measure, a method of approximation is often used. One way would be to estimate the curve via curve-fitting techniques. For this outcome, using area over the curve and <60mg/dl provides a more robust method of calculating amount of hypoglycemia (by including more severe degrees of hypoglycemia in the product of mg/dl*min as opposed to percentage of time below 60mg/dl.
Measured: 14 days
Secondary outcomes (15)
Mean Continuous Glucose Monitor (CGM) Glucose
Measured: 2 weeks
Percentage of Time With CGM Glucose Less Than 60 mg/dl Overnight (11:00 PM - 7:00 AM)
Measured: 14 days
Percentage of Time With CGM Glucose Less Than 60 mg/dl During Daytime ( 7:00 AM-11:00 PM)
Measured: 14 days
Percentage of Time Spent Within the Glucose Range 70-120 mg/dl
Measured: 14 days
Percentage of Time Spent Within the Glucose Range 70-180 mg/dl
Measured: 14 days
Percentage of Time Spent Within the Glucose Range >180 mg/dl
Measured: 14 days
Fraction of Time Spent Within the Glucose Range >250 mg/dl
Measured: 2 weeks
Mean Absolute Relative Deviation (MARD) of CGM vs. All StatStrip Xpress BG Measurements
MARD is computed using the difference between the CGM readings and the values measured at the same time by the reference measurement system. The mean (or average) of all the absolute relative deviations produces the MARD. In this study, the reference measurement system was the StatStrip Xpress meter, to which the CGM values were compared.
Measured: 14 days
Number of Carbohydrate Interventions for Hypoglycemia Per Day
Number of carbohydrate interventions for hypoglycemia per day calculated from daily email survey
Measured: 14 days
Total Number of Grams of Carbohydrate Taken for Hypoglycemia Per Day
Calculated from daily email survey
Measured: 14 days
Total Glucagon Dosing (mcg/kg/24 Hours)
Measured: 2 weeks
Number of Symptomatic Hypoglycemia Events Per Day
Number of symptomatic hypoglycemia events per day calculated from daily email survey
Measured: 14 days
Percentage of Days When Participants Correctly Guessed Intervention (Glucagon vs Placebo) Out of a Total of 14 Days.
Measured: 2 weeks
Number of Days With Nausea
Number of days with nausea calculated from daily survey
Measured: 14 days
Severity of Nausea on Daily E-mail Survey
The visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. We used a simple VAS is a straight horizontal line of fixed length measuring 0-100mm with subscale markings every 10mm. The ends are defined as the extreme limits of the parameter to be measured (nausea) orientated from the left (least severity or 0) to the right (most severity or 100mm). Subjects can mark their response anywhere from 0 to 100mm. The mean severity of nausea for the group in each arm was calculated by averaging all responses in either arm.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2017
- Study completionDec 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 HypoglycemiaStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Joslin Diabetes Center
- Responsible party
- Principal investigator, Steven J. Russell, MD, PhD, Massachusetts General Hospital
- Investigators
- Steven J Russell, MD, PhD, Principal investigator, Massachusetts General Hospital, Boston, Massachusetts
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02966275
- Sponsor's protocol ID
- 2016P000710
- Status last verified
- Nov 2018
- First submitted
- 10 May 2016
- Last updated
- 13 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closed-Loop Glucagon Administration For The Automated Treatment Of Post-Bariatric Hypoglycemia
- ClinicalTrials.gov ID
- NCT02966275
- Acronym / sponsor ID
- 2016P000710
- Conditions
- Hypoglycemia
- Keywords
- glucagon, continuous glucose monitorering (CGM), artificial pancreas, hypoglycemia, post-bariatric hypoglycemia, bionic pancreas, bariatric surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Joslin Diabetes Center
- Study start
- Sep 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 17 Nov 2016 (estimated)
- Results
- Posted 23 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to test our automated hypoglycemia prevention and treatment device (glucagon-only bionic pancreas) in subjects that have undergone post-bariatric surgery that are experiencing symptoms of hypoglycemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glucagon-only bionic pancreas - glucagon | Experimental | Device: Glucagon-only bionic pancreas - glucagonSubjects will wear the bionic pancreas that consists of a continuous glucose monitor linked to a smartphone running a hypoglycemia prevention algorithm that doses glucagon from an insulin pump through a subcutaneous infusion set. Subjects will continue to manage any hypoglycemia that occurs according to the current recommendations of their care provider. |
| Glucagon-only bionic pancreas - placebo | Placebo comparator | Device: Glucagon-only bionic pancreas - placeboSubjects will wear the bionic pancreas that consists of a continuous glucose monitor linked to a smartphone running a hypoglycemia prevention algorithm that doses placebo from an insulin pump through a subcutaneous infusion set. Subjects will continue to manage any hypoglycemia that occurs according to the current recommendations of their care provider. |
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 a gastric bypass for more than 1 year.
- Post-bariatric hypoglycemia with prior episodes of neuroglycopenia, unresponsive to dietary intervention (low glycemic index, controlled carbohydrate portions) and trial of acarbose therapy at the maximally tolerated dose. Other therapies will not exclude a subject as long as the therapy is continued during the study.
- 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 verified by capillary blood glucose measurements) of at least 2 times per week.
Key exclusion criteria (23 listed)
- Unable to provide informed consent.
- Unable to comply with study procedures.
- Current participation in another hypoglycemia 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.
- Use of insulin and/or insulin secretogues as sulfonylurea, metglitides, and glitazones.
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 pancreas - glucagonA computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor. | Device | Glucagon-only bionic pancreas - glucagon |
| Glucagon-only bionic pancreas - placeboA computer algorithm will automatically deliver placebo based on the signal from a minimally invasive continuous glucose monitor. | Device | Glucagon-only bionic pancreas - placebo |
Primary outcome
Area Over the Curve and <60 mg/dl (CGM) Measured in mg/dl *Min
Time frame: 14 days
The measure for area over the curve is used when an integrated assessment (e.g., a measurement of something over a specific amount of time) is more useful in understanding a phenomenon. To calculate this measure, a method of approximation is often used. One way would be to estimate the curve via curve-fitting techniques. For this outcome, using area over the curve and <60mg/dl provides a more robust method of calculating amount of hypoglycemia (by including more severe degrees of hypoglycemia in the product of mg/dl*min as opposed to percentage of time below 60mg/dl.
15 secondary outcomes
Mean Continuous Glucose Monitor (CGM) Glucose
Time frame: 2 weeks
Percentage of Time With CGM Glucose Less Than 60 mg/dl Overnight (11:00 PM - 7:00 AM)
Time frame: 14 days
Percentage of Time With CGM Glucose Less Than 60 mg/dl During Daytime ( 7:00 AM-11:00 PM)
Time frame: 14 days
Percentage of Time Spent Within the Glucose Range 70-120 mg/dl
Time frame: 14 days
Percentage of Time Spent Within the Glucose Range 70-180 mg/dl
Time frame: 14 days
Percentage of Time Spent Within the Glucose Range >180 mg/dl
Time frame: 14 days
Fraction of Time Spent Within the Glucose Range >250 mg/dl
Time frame: 2 weeks
Mean Absolute Relative Deviation (MARD) of CGM vs. All StatStrip Xpress BG Measurements
Time frame: 14 days
Number of Carbohydrate Interventions for Hypoglycemia Per Day
Time frame: 14 days
Total Number of Grams of Carbohydrate Taken for Hypoglycemia Per Day
Time frame: 14 days
Total Glucagon Dosing (mcg/kg/24 Hours)
Time frame: 2 weeks
Number of Symptomatic Hypoglycemia Events Per Day
Time frame: 14 days
Percentage of Days When Participants Correctly Guessed Intervention (Glucagon vs Placebo) Out of a Total of 14 Days.
Time frame: 2 weeks
Number of Days With Nausea
Time frame: 14 days
Severity of Nausea on Daily E-mail Survey
Time frame: 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Information about this and related studiesLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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, Boston, Massachusetts
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 - glucagon in people with Hypoglycemia, 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 23 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 13 Dec 2018. 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 23 Nov 2018). 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?
Area Over the Curve and <60 mg/dl (CGM) Measured in mg/dl *Min (time frame: 14 days). 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 13 Dec 2018.