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Integration of Continuous Glucose Monitoring Into a BiHormonal Closed-Loop Artificial Pancreas | Clinical Trials | Clareo Health

COMPLETEDNA

Integration of Continuous Glucose Monitoring Into a BiHormonal Closed-Loop Artificial Pancreas

Integration of Continuous Glucose Monitoring Into a Bi-Hormonal Closed-Loop Artificial Pancreas for Automated Management of Type 1 Diabetes

NCT01161862•Boston University Charles River Campus

View on ClinicalTrials.gov

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.

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.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

Exclusion Criteria

•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)
+24 more criteria

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States

Key Dates

Start Date

July 1, 2010

Primary Completion Date

December 1, 2012

Completion Date

June 1, 2013

Last Updated

November 14, 2017

Enrollment

ACTUAL participants

Conditions

Diabetes Mellitus

Interventions

Bi-hormonal (insulin and glucagon) artificial pancreas

DEVICE

Genetic Studies of Insulin and Diabetes

NCT00001987

Diabetes MellitusSevere Insulin Resistance

View study

RECRUITINGNA

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 14, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Integration of Continuous Glucose Monitoring Into a BiHormonal Closed-Loop Artificial Pancreas

Inclusion Criteria

Exclusion Criteria

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