Integration of Continuous Glucose Monitoring Into a BiHormonal Closed-Loop Artificial Pancreas
CL2
2 other identifiers
interventional
24
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes-mellitus
Started Jul 2010
Typical duration for not_applicable diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 12, 2010
CompletedFirst Posted
Study publicly available on registry
July 14, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedResults Posted
Study results publicly available
November 14, 2017
CompletedNovember 14, 2017
October 1, 2017
2.4 years
July 12, 2010
October 31, 2016
October 13, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Plasma Blood Glucose Achieved by the Bionic Pancreas (mg/dl)
48 hours
Secondary Outcomes (7)
Percentage of Time Spent With Blood Glucose < 60 mg/dl
48 hours
Percentage of Time Spent With Blood Glucose <70 mg/dl
48 hours
Percentage of Time Spent With Blood Glucose 70-180 mg/dl
48 hours
Insulin Total Daily Dose
48 hours
Number of Carbohydrate Interventions for Hypoglycemia
48 hours
- +2 more secondary outcomes
Study Arms (2)
Bi-hormonal with meal-priming bolus
EXPERIMENTALThe 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
EXPERIMENTALThe insulin controller was entirely reactive to CGMG; there were no meal priming boluses and no meal announcements
Interventions
Subjects wore a bionic pancreas consisting of a continuous glucose monitor, an insulin pump and a glucagon pump
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
- 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)
- +19 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Related Publications (2)
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.
PMID: 23275350DERIVEDRussell 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.
PMID: 22923666DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Edward R. Damiano
- Organization
- Department of Biomedical Engineering, Boston University, Boston, Massachusetts.
Study Officials
- PRINCIPAL INVESTIGATOR
Steven J Russell, MD, PhD
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Biomedical Engineering
Study Record Dates
First Submitted
July 12, 2010
First Posted
July 14, 2010
Study Start
July 1, 2010
Primary Completion
December 1, 2012
Study Completion
June 1, 2013
Last Updated
November 14, 2017
Results First Posted
November 14, 2017
Record last verified: 2017-10