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Trial · Interventional

CompletedNot applicableResults postedRegistry data

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

Short name CL2

NCTNCT01161862 (opens ClinicalTrials.gov in a new tab)Other idH-29293Other id1R01DK085633-01

Overview

Status
Completed
Phase
Not applicable
Enrollment
24 participants (actual)
Sponsor
Boston University Charles River Campus · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Jul 2010
Primary completion
Dec 2012
Completion
Jun 2013
First posted
14 Jul 2010 (estimated)
Last update posted
14 Nov 2017
Conditions
Diabetes Mellitus

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20102011201220132014
  1. N/A

    CL2

    NCT01161862

    Jul 2010 to Jun 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Bi-hormonal (insulin and glucagon) artificial pancreasDevice

Arms2

  • Experimental

    Bi-hormonal with meal-priming bolus

    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

  • Experimental

    Bi-hormonal without meal-priming bolus

    The insulin controller was entirely reactive to CGMG; there were no meal priming boluses and no meal announcements

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Mean Plasma Blood Glucose Achieved by the Bionic Pancreas (mg/dl)

    Time frame · 48 hours

Secondary outcomes(7)
  1. Percentage of Time Spent With Blood Glucose < 60 mg/dl

    Time frame · 48 hours

  2. Percentage of Time Spent With Blood Glucose <70 mg/dl

    Time frame · 48 hours

  3. Percentage of Time Spent With Blood Glucose 70-180 mg/dl

    Time frame · 48 hours

  4. Insulin Total Daily Dose

    Time frame · 48 hours

  5. Number of Carbohydrate Interventions for Hypoglycemia

    Time frame · 48 hours

  6. Number of Blood Glucose Events < 70 mg/dl

    Time frame · 48 hours

  7. Nadir Blood Glucose in Each Arm

    Time frame · 48 hours

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 48 hours

Mean Plasma Blood Glucose Achieved by the Bionic Pancreas (mg/dl)

GroupValue (mg/dl)Spread
Bionic Pancreas With Automated Meal-priming Bolus1323
Bionic Pancreas Without Automated Meal-priming Bolus1469
Secondary and other outcome results(7)
Secondary outcomeMean· 48 hours

Percentage of Time Spent With Blood Glucose < 60 mg/dl

GroupValue (percentage of total time)Spread
Bionic Pancreas With Automated Meal-priming Bolus2.33.9
Bionic Pancreas Without Automated Meal-priming Bolus1.42.7
Secondary outcomeMean· 48 hours

Percentage of Time Spent With Blood Glucose <70 mg/dl

GroupValue (percentage of total time)Spread
Bionic Pancreas With Automated Meal-priming Bolus5.16.7
Bionic Pancreas Without Automated Meal-priming Bolus3.64.5
Secondary outcomeMean· 48 hours

Percentage of Time Spent With Blood Glucose 70-180 mg/dl

GroupValue (percentage of total time)Spread
Bionic Pancreas With Automated Meal-priming Bolus806
Bionic Pancreas Without Automated Meal-priming Bolus709
Secondary outcomeMean· 48 hours

Insulin Total Daily Dose

GroupValue (u/kg/day)Spread
Bionic Pancreas With Automated Meal-priming Bolus0.60.2
Bionic Pancreas Without Automated Meal-priming Bolus0.70.2
Secondary outcomeNumber· 48 hours

Number of Carbohydrate Interventions for Hypoglycemia

GroupValue (Carbohydrate Interventions)
Bi-hormonal With Meal Priming Bolus12
Bi-hormonal Without Meal Priming Bolus10
Secondary outcomeNumber· 48 hours

Number of Blood Glucose Events < 70 mg/dl

GroupValue (Number of events)
Bi-hormonal With Meal Priming Bolus59
Bi-hormonal Without Meal Priming Bolus48
Secondary outcomeMean· 48 hours

Nadir Blood Glucose in Each Arm

GroupValue (mg/dl)Spread
Bionic Pancreas With Automated Meal-priming Bolus65.917.4
Bionic Pancreas Without Automated Meal-priming Bolus66.417.8

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Bi-hormonal With Meal Priming BolusBi-hormonal with adaptive meal priming bolus0 / 120 / 121 / 12
Bi-hormonal Without Meal Priming BolusBi-hormonal with no meal announcements or meal priming boluses0 / 120 / 121 / 12

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedDamiano 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 23275350
  • DerivedRussell 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 22923666

Eligibility

Who could join, as posted.

Sex
All
Age
from 12 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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) * 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

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