Diabetes MellitusCL2NCT01161862
Integration of Continuous Glucose Monitoring Into a BiHormonal Closed-Loop Artificial Pancreas
A study testing Bi-hormonal (insulin and glucagon) artificial pancreas in people with Diabetes Mellitus, run by Boston University Charles River Campus at 1 site in United States.
Trial summary
The investigators hypothesize that our closed-loop glucose-control system can provide BG control in subjects with type 1 diabetes using the estimated BG signal from a CGM as the input signal to the controller. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Bi-hormonal (insulin and glucagon) artificial pancreas
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jun 2013
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 12 years or older with clinical type 1 diabetes for at least one year
- Weight > 41 kg
- Otherwise healthy (mild chronic disease allowed if well controlled)
- Diabetes managed using an insulin infusion pump and rapid- or very-rapid-acting insulins
- Body mass index (BMI) between 20 and 35 for subjects >18 years of age or BMI between the 5th and 95th percentile for age for subjects < 18 years of age
- Total daily dose (TDD) of insulin that is < 1 U/kg
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- Stimulated C-peptide < 0.1 nmol/L at 90 minutes after liquid mixed meal by DCCT protocol
- Hemoglobin A1c <= 9%
- Prescription medication regimen stable for 1 month
Who cannot join
- Unable to provide informed consent for subjects > 18 years of age or unable to provide assent if < 18 years of age
- Unable to comply with study procedures
- Current participation in another diabetes-related clinical trial other than one that is primarily observational in nature. Potential subjects enrolled in trials of passive monitoring equipment are not excluded.
- Anemia (HCT less than normal for age and sex)
- Alanine aminotransferase > 3 fold above upper limit of normal
- Untreated or inadequately treated hyperthyroidism or hypothyroidism
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- Pregnancy
- Renal insufficiency (creatinine clearance ≤ 50 ml/min)
- Any known history of coronary artery disease
- Abnormal EKG including, but not limited to evidence of active ischemia, prior myocardial infarction, proximal LAD critical stenosis (Wellen's sign), arrhythmia, tachycardia, and prolonged QT interval (> 440 ms)
- Congestive heart failure
- History of TIA or stroke
- Acute illness or exacerbation of chronic illness
- History of seizures
- History of pheochromocytoma (fractionated metanephrines will be tested in patients with history suggestive of pheochromocytoma)
- History of adrenal disease or tumor
- History of pancreatic tumor, including insulinoma
- History of impaired gastric motility or gastroparesis requiring pharmacological or surgical treatment
- 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)
- Untreated or inadequately treated mental illness (indicators would include symptoms such as psychosis, hallucinations, mania, and any psychiatric hospitalization in the last year)
- Impaired cognition or altered mental status.
- Hypertension (blood pressure > 140/90 or > 95% for age, height and weight in subjects < 18 years of age) at the time of screening
- Use of medications that reduce gastric motility (e.g. narcotics, anti-spasmodics, anticholinergics).
- Electrically powered implants (e.g. cochlear implants, neurostimulators) that might be susceptible to RF interference
- Use non-insulin, injectable anti-diabetic medications
- History of adverse reaction to glucagon (including allergy) besides nausea and vomiting.
- Established history of latex, adhesive, or tape allergy
- Inadequate venous access
- History of allergy to aspirin or any history of aspirin intolerance, including Reye syndrome, or gastric ulcer or bleeding associated with salicylates
- Blood dyscrasia or bleeding diathesis, such as hemophilia, Von Willebrands disorder, and idiopathic thrombocytopenic purpura (ITP)
- Peptic ulcer
- Unable to perform 30 minutes of moderate exercise on a treadmill or exercise bicycle
- Unable or unwilling to discontinue dietary supplements for at least 2 weeks prior to each CRC admission
- History of celiac disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Integration of Continuous Glucose Monitoring Into a Bi-Hormonal Closed-Loop Artificial Pancreas for Automated Management of Type 1 Diabetes
The investigators hypothesize that our closed-loop glucose-control system can provide BG control in subjects with type 1 diabetes using the estimated BG signal from a CGM as the input signal to the controller.
Read the detailed description
To test the safety and efficacy of our control system in the bi-hormonal configuration in regulating BG in adults (18 years of age or older) and in children (12-17 years of age) with type 1 diabetes based on interstitial-fluid (ISF) glucose data from a CGM. Experiments will be 51 hours in length incorporating 6 meals and two (night) sleep periods. In order to evaluate the effect of exercise on BG control, the last 48 hours of the experiment will be divided into two 24 hour blocks, the second of which will contain a period of structured exercise near the beginning of the block.
- Conditions
- Diabetes Mellitus
- Being tested
- Bi-hormonal (insulin and glucagon) artificial pancreas
- Keywords
- Closed-loop, Artificial pancreas, Bi-hormonal, Insulin, Glucagon, Diabetes mellitus type 1
- Medical subject headings
- Diabetes Mellitus, Insulin Resistance, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bi-hormonal (insulin and glucagon) artificial pancreasDevice
Subjects wore a bionic pancreas consisting of a continuous glucose monitor, an insulin pump and a glucagon pump
| Study group | Role | What they receive |
|---|---|---|
| Bi-hormonal with meal-priming bolus | Experimental | The first meal-priming bolus was solely based on weight (0.05 U/kg), after which meal-priming boluses were automatically adapted by the control system online targeting 75% of the anticipated insulin needed in the first four hours after the start of the meal Receives: Device: Bi-hormonal (insulin and glucagon) artificial pancreas |
| Bi-hormonal without meal-priming bolus | Experimental | The insulin controller was entirely reactive to CGMG; there were no meal priming boluses and no meal announcements Receives: Device: Bi-hormonal (insulin and glucagon) artificial pancreas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Plasma Blood Glucose Achieved by the Bionic Pancreas (mg/dl)
Measured: 48 hours
Secondary outcomes (7)
Percentage of Time Spent With Blood Glucose < 60 mg/dl
Measured: 48 hours
Percentage of Time Spent With Blood Glucose <70 mg/dl
Measured: 48 hours
Percentage of Time Spent With Blood Glucose 70-180 mg/dl
Measured: 48 hours
Insulin Total Daily Dose
Measured: 48 hours
Number of Carbohydrate Interventions for Hypoglycemia
Measured: 48 hours
Number of Blood Glucose Events < 70 mg/dl
Measured: 48 hours
Nadir Blood Glucose in Each Arm
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionDec 2012
- Study completionJun 2013
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Juvenile Diabetes Research Foundation, The Leona M. and Harry B. Helmsley Charitable Trust
- Responsible party
- Principal investigator, Edward R. Damiano, Boston University
- Investigators
- Steven J Russell, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01161862
- Sponsor's protocol ID
- H-29293
- Other IDs
- 1R01DK085633-01
- Acronym
- CL2
- Status last verified
- Oct 2017
- First submitted
- 12 Jul 2010
- Last updated
- 14 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Damiano ER, El-Khatib FH, Zheng H, Nathan DM, Russell SJ. A comparative effectiveness analysis of three continuous glucose monitors. Diabetes Care. 2013 Feb;36(2):251-9. doi: 10.2337/dc12-0070. Epub 2012 Dec 28.
PubMed 23275350Russell SJ, El-Khatib FH, Nathan DM, Magyar KL, Jiang J, Damiano ER. Blood glucose control in type 1 diabetes with a bihormonal bionic endocrine pancreas. Diabetes Care. 2012 Nov;35(11):2148-55. doi: 10.2337/dc12-0071. Epub 2012 Aug 24.
PubMed 22923666
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration of Continuous Glucose Monitoring Into a Bi-Hormonal Closed-Loop Artificial Pancreas for Automated Management of Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT01161862
- Acronym / sponsor ID
- CL2 / H-29293
- Conditions
- Diabetes Mellitus
- Keywords
- Closed-loop, Artificial pancreas, Bi-hormonal, Insulin, Glucagon, Diabetes mellitus type 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Juvenile Diabetes Research Foundation, The Leona M. and Harry B. Helmsley Charitable Trust
- Study start
- Jul 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 14 Jul 2010 (estimated)
- Results
- Posted 14 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators hypothesize that our closed-loop glucose-control system can provide BG control in subjects with type 1 diabetes using the estimated BG signal from a CGM as the input signal to the controller.
Detailed description
To test the safety and efficacy of our control system in the bi-hormonal configuration in regulating BG in adults (18 years of age or older) and in children (12-17 years of age) with type 1 diabetes based on interstitial-fluid (ISF) glucose data from a CGM. Experiments will be 51 hours in length incorporating 6 meals and two (night) sleep periods. In order to evaluate the effect of exercise on BG control, the last 48 hours of the experiment will be divided into two 24 hour blocks, the second of which will contain a period of structured exercise near the beginning of the block.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bi-hormonal with meal-priming bolus | Experimental | Device: Bi-hormonal (insulin and glucagon) artificial pancreasThe first meal-priming bolus was solely based on weight (0.05 U/kg), after which meal-priming boluses were automatically adapted by the control system online targeting 75% of the anticipated insulin needed in the first four hours after the start of the meal |
| Bi-hormonal without meal-priming bolus | Experimental | Device: Bi-hormonal (insulin and glucagon) artificial pancreasThe insulin controller was entirely reactive to CGMG; there were no meal priming boluses and no meal announcements |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Age 12 years or older with clinical type 1 diabetes for at least one year
- Weight > 41 kg
- Otherwise healthy (mild chronic disease allowed if well controlled)
- Diabetes managed using an insulin infusion pump and rapid- or very-rapid-acting insulins
- Body mass index (BMI) between 20 and 35 for subjects >18 years of age or BMI between the 5th and 95th percentile for age for subjects < 18 years of age
Key exclusion criteria (34 listed)
- Unable to provide informed consent for subjects > 18 years of age or unable to provide assent if < 18 years of age
- Unable to comply with study procedures
- Current participation in another diabetes-related clinical trial other than one that is primarily observational in nature. Potential subjects enrolled in trials of passive monitoring equipment are not excluded.
- Anemia (HCT less than normal for age and sex)
- Alanine aminotransferase > 3 fold above upper limit of normal
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 |
|---|---|---|
| Bi-hormonal (insulin and glucagon) artificial pancreasSubjects wore a bionic pancreas consisting of a continuous glucose monitor, an insulin pump and a glucagon pump | Device | Bi-hormonal with meal-priming bolus, Bi-hormonal without meal-priming bolus |
Primary outcome
Mean Plasma Blood Glucose Achieved by the Bionic Pancreas (mg/dl)
Time frame: 48 hours
7 secondary outcomes
Percentage of Time Spent With Blood Glucose < 60 mg/dl
Time frame: 48 hours
Percentage of Time Spent With Blood Glucose <70 mg/dl
Time frame: 48 hours
Percentage of Time Spent With Blood Glucose 70-180 mg/dl
Time frame: 48 hours
Insulin Total Daily Dose
Time frame: 48 hours
Number of Carbohydrate Interventions for Hypoglycemia
Time frame: 48 hours
Number of Blood Glucose Events < 70 mg/dl
Time frame: 48 hours
Nadir Blood Glucose in Each Arm
Time frame: 48 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23275350Damiano ER, El-Khatib FH, Zheng H, Nathan DM, Russell SJ. A comparative effectiveness analysis of three continuous glucose monitors. Diabetes Care. 2013 Feb;36(2):251-9. doi: 10.2337/dc12-0070. Epub 2012 Dec 28.
- Derived from this study: PubMed 22923666Russell SJ, El-Khatib FH, Nathan DM, Magyar KL, Jiang J, Damiano ER. Blood glucose control in type 1 diabetes with a bihormonal bionic endocrine pancreas. Diabetes Care. 2012 Nov;35(11):2148-55. doi: 10.2337/dc12-0071. Epub 2012 Aug 24.
- Related InfoLink provided by the sponsor.
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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 Bi-hormonal (insulin and glucagon) artificial pancreas in people with Diabetes Mellitus, run by Boston University Charles River Campus 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 9 inclusion and 34 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 14 Nov 2017. 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. 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 14 Nov 2017). 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?
Mean Plasma Blood Glucose Achieved by the Bionic Pancreas (mg/dl) (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01161862, which also lists 2 linked publications.
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 14 Nov 2017.