ID

36282

Description

An Open Label, Pilot Investigation, to Assess the Safety and Efficacy of Transplantation of Macro-encapsulated Human Islets Within the Bioartificial Pancreas Beta-Air in Patients With Type 1 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT02064309

Link

https://clinicaltrials.gov/show/NCT02064309

Keywords

Versions (1)
  1. 4/29/19 4/29/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 29, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Long-standing Type 1 Diabetes Mellitus NCT02064309

English

Eligibility Long-standing Type 1 Diabetes Mellitus NCT02064309

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. informed consent obtained before any investigation-related activities. investigation-related activities are any procedure that would not have been performed during normal management of the subject.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
2. diagnosis of type 1 diabetes mellitus for > 5 years
Description

Insulin-Dependent Diabetes Mellitus Disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0872146
3. men or women > 18 years of age at the time of enrolment
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
4. involvement in intensive diabetes management defined as self-monitoring of blood glucose level no less than a mean of three times per day averaged over each week and by the administration of three or more insulin injections per day or insulin pump therapy. this management must be under the direction of a diabetologist or diabetes specialist during the 12 months prior to study enrolment.
Description

Diabetes mellitus management With intensity | Blood Glucose Self-Monitoring times/day | Insulin injection Quantity per day | Insulin pump Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0948092
UMLS CUI [1,2]
C0522510
UMLS CUI [2,1]
C0005803
UMLS CUI [2,2]
C0439511
UMLS CUI [3,1]
C0199782
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0439505
UMLS CUI [4,1]
C1140609
UMLS CUI [4,2]
C0087111
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. body mass index (bmi) > 30 kg/m²
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
2. insulin requirement of > 1.0 units/kg/day
Description

Patient need for Insulin Unit/kilogram/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0021641
UMLS CUI [1,3]
C1532634
3. hba1c > 10 % (dcct)
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
4. random c-peptide > 0.003 nmol/l
Description

C-peptide measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202100
5. known untreated active proliferative diabetic retinopathy changes or increasing macular oedema
Description

Proliferative diabetic retinopathy Change Untreated | Macular edema Increasing

Data type

boolean

Alias
UMLS CUI [1,1]
C0154830
UMLS CUI [1,2]
C0392747
UMLS CUI [1,3]
C0332155
UMLS CUI [2,1]
C0271051
UMLS CUI [2,2]
C0442808
6. renal failure (glomerular filtration rate <60 ml/min)
Description

Kidney Failure | Glomerular Filtration Rate

Data type

boolean

Alias
UMLS CUI [1]
C0035078
UMLS CUI [2]
C0017654
7. women of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or unwilling to use adequate contraceptive methods for the duration of the trial (implants, injectables, combined oral contraceptives, hormonal intrauterine device, sexual abstinence or vasectomised partner).
Description

Pregnancy | Breast Feeding | Childbearing Potential Planned Pregnancy | Childbearing Potential Contraceptive methods Unwilling | Contraceptive implant | Injectable contraception | Combined Oral Contraceptives | Hormone-Releasing Intrauterine Devices | Sexual Abstinence | Partner had vasectomy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0032992
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C0558080
UMLS CUI [5]
C1657106
UMLS CUI [6]
C1262153
UMLS CUI [7]
C0009906
UMLS CUI [8]
C0021902
UMLS CUI [9]
C0036899
UMLS CUI [10]
C0420842
8. active infection including hepatitis b, hepatitis c, hiv, tbc
Description

Communicable Disease | Hepatitis B | Hepatitis C | HIV Infection | Tuberculosis

Data type

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
UMLS CUI [4]
C0019693
UMLS CUI [5]
C0041296
9. any history of malignancy except for completely resected squamous or basal cell carcinoma of the skin
Description

Malignant Neoplasms | Exception Complete excision Squamous cell carcinoma of skin | Exception Complete excision Basal cell carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0015250
UMLS CUI [2,3]
C0553723
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0015250
UMLS CUI [3,3]
C0007117
10. known active alcohol or drug abuse.
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
11. any coagulopathy or medical condition that would require long-term anticoagulant therapy (e.g., warfarin) after transplantation (low-dose aspirin treatment is allowed) or subjects with an international normalized ratio (inr) > 1.5.
Description

Blood Coagulation Disorders Requirement Anticoagulant therapy Long-term | Medical condition Requirement Anticoagulant therapy Long-term | Warfarin | Status post Transplantation | Aspirin Low Dose allowed | International Normalized Ratio

Data type

boolean

Alias
UMLS CUI [1,1]
C0005779
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0150457
UMLS CUI [1,4]
C0443252
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0150457
UMLS CUI [2,4]
C0443252
UMLS CUI [3]
C0043031
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C0040732
UMLS CUI [5,1]
C2608320
UMLS CUI [5,2]
C0683607
UMLS CUI [6]
C0525032
12. severe co-existing cardiac disease, characterized by any of these conditions:
Description

Heart Disease Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205082
1. recent myocardial infarction (within past 36 weeks)
Description

Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0027051
2. evidence of ischemia on functional cardiac exam within the last year
Description

Ischemia Heart Function Tests

Data type

boolean

Alias
UMLS CUI [1,1]
C0022116
UMLS CUI [1,2]
C0018803
3. left ventricular ejection fraction < 30 %
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
4. cardiovascular conditions within 36 weeks prior to this trial:
Description

Cardiovascular Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0007222
i. decompensated heart failure new york heart association (nyha) class iii or iv ii. unstable angina pectoris iii. coronary arterial bypass graft iv. coronary angioplasty
Description

Decompensated cardiac failure New York Heart Association Classification | Angina, Unstable | Coronary Artery Bypass Surgery | Coronary angioplasty

Data type

boolean

Alias
UMLS CUI [1,1]
C0581377
UMLS CUI [1,2]
C1275491
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0010055
UMLS CUI [4]
C0190211
13. inadequately treated blood pressure elevation (systolic bp > 160 mmhg or diastolic blood pressure > 100 mmhg)
Description

Increase in blood pressure Treated Inadequate | Systolic Pressure | Diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1,1]
C0497247
UMLS CUI [1,2]
C1522326
UMLS CUI [1,3]
C0205412
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
14. use of any medications to treat diabetes other than insulin within 4 weeks of enrolment
Description

Antidiabetics | Exception Insulin

Data type

boolean

Alias
UMLS CUI [1]
C0935929
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0021641
15. administration of live attenuated vaccine(s) within 8 weeks of enrolment
Description

Vaccines, Attenuated

Data type

boolean

Alias
UMLS CUI [1]
C0042211
16. any previous organ transplant
Description

Organ Transplantation

Data type

boolean

Alias
UMLS CUI [1]
C0029216
17. treatment with any immunosuppressive drug
Description

Immunosuppressive Agents

Data type

boolean

Alias
UMLS CUI [1]
C0021081
18. any medical condition that, in the opinion of the investigator, will interfere with safe participation in the trial (e.g., systemic glucocorticoids)
Description

Medical condition Interferes with Study Subject Participation Status | Glucocorticoids, Systemic

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
UMLS CUI [2]
C3540777
19. known or suspected allergy of hypersensitivity to trial product(s) or related products
Description

Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related | Hypersensitivity Suspected Pharmaceutical Preparations Related

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0750491
UMLS CUI [2,3]
C0013230
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0013227
UMLS CUI [3,3]
C0439849
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0750491
UMLS CUI [4,3]
C0013227
UMLS CUI [4,4]
C0439849
20. the receipt of any investigational product within 30 days of screening for this trial
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
21. any scheduled transplant in addition to the islet transplantation
Description

Transplantation Scheduled In addition to Islet Transplantation

Data type

boolean

Alias
UMLS CUI [1,1]
C0040732
UMLS CUI [1,2]
C0205539
UMLS CUI [1,3]
C0332287
UMLS CUI [1,4]
C0079646
22. fulfillment of criteria for clinical pancreas or islet transplantation
Description

Criteria Fulfill Pancreas Transplantation | Criteria Fulfill Islet Transplantation

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
UMLS CUI [1,3]
C0030275
UMLS CUI [2,1]
C0243161
UMLS CUI [2,2]
C1550543
UMLS CUI [2,3]
C0079646
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Similar models

Eligibility Long-standing Type 1 Diabetes Mellitus NCT02064309

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. informed consent obtained before any investigation-related activities. investigation-related activities are any procedure that would not have been performed during normal management of the subject.
boolean
C0021430 (UMLS CUI [1])
Insulin-Dependent Diabetes Mellitus Disease length
Item
2. diagnosis of type 1 diabetes mellitus for > 5 years
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Age
Item
3. men or women > 18 years of age at the time of enrolment
boolean
C0001779 (UMLS CUI [1])
Diabetes mellitus management With intensity | Blood Glucose Self-Monitoring times/day | Insulin injection Quantity per day | Insulin pump Therapy
Item
4. involvement in intensive diabetes management defined as self-monitoring of blood glucose level no less than a mean of three times per day averaged over each week and by the administration of three or more insulin injections per day or insulin pump therapy. this management must be under the direction of a diabetologist or diabetes specialist during the 12 months prior to study enrolment.
boolean
C0948092 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0005803 (UMLS CUI [2,1])
C0439511 (UMLS CUI [2,2])
C0199782 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0439505 (UMLS CUI [3,3])
C1140609 (UMLS CUI [4,1])
C0087111 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Body mass index
Item
1. body mass index (bmi) > 30 kg/m²
boolean
C1305855 (UMLS CUI [1])
Patient need for Insulin Unit/kilogram/day
Item
2. insulin requirement of > 1.0 units/kg/day
boolean
C0686904 (UMLS CUI [1,1])
C0021641 (UMLS CUI [1,2])
C1532634 (UMLS CUI [1,3])
Hemoglobin A1c measurement
Item
3. hba1c > 10 % (dcct)
boolean
C0474680 (UMLS CUI [1])
C-peptide measurement
Item
4. random c-peptide > 0.003 nmol/l
boolean
C0202100 (UMLS CUI [1])
Proliferative diabetic retinopathy Change Untreated | Macular edema Increasing
Item
5. known untreated active proliferative diabetic retinopathy changes or increasing macular oedema
boolean
C0154830 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0332155 (UMLS CUI [1,3])
C0271051 (UMLS CUI [2,1])
C0442808 (UMLS CUI [2,2])
Kidney Failure | Glomerular Filtration Rate
Item
6. renal failure (glomerular filtration rate <60 ml/min)
boolean
C0035078 (UMLS CUI [1])
C0017654 (UMLS CUI [2])
Pregnancy | Breast Feeding | Childbearing Potential Planned Pregnancy | Childbearing Potential Contraceptive methods Unwilling | Contraceptive implant | Injectable contraception | Combined Oral Contraceptives | Hormone-Releasing Intrauterine Devices | Sexual Abstinence | Partner had vasectomy
Item
7. women of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or unwilling to use adequate contraceptive methods for the duration of the trial (implants, injectables, combined oral contraceptives, hormonal intrauterine device, sexual abstinence or vasectomised partner).
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0032992 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0558080 (UMLS CUI [4,3])
C1657106 (UMLS CUI [5])
C1262153 (UMLS CUI [6])
C0009906 (UMLS CUI [7])
C0021902 (UMLS CUI [8])
C0036899 (UMLS CUI [9])
C0420842 (UMLS CUI [10])
Communicable Disease | Hepatitis B | Hepatitis C | HIV Infection | Tuberculosis
Item
8. active infection including hepatitis b, hepatitis c, hiv, tbc
boolean
C0009450 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
C0019693 (UMLS CUI [4])
C0041296 (UMLS CUI [5])
Malignant Neoplasms | Exception Complete excision Squamous cell carcinoma of skin | Exception Complete excision Basal cell carcinoma
Item
9. any history of malignancy except for completely resected squamous or basal cell carcinoma of the skin
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0015250 (UMLS CUI [2,2])
C0553723 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0015250 (UMLS CUI [3,2])
C0007117 (UMLS CUI [3,3])
Substance Use Disorders
Item
10. known active alcohol or drug abuse.
boolean
C0038586 (UMLS CUI [1])
Blood Coagulation Disorders Requirement Anticoagulant therapy Long-term | Medical condition Requirement Anticoagulant therapy Long-term | Warfarin | Status post Transplantation | Aspirin Low Dose allowed | International Normalized Ratio
Item
11. any coagulopathy or medical condition that would require long-term anticoagulant therapy (e.g., warfarin) after transplantation (low-dose aspirin treatment is allowed) or subjects with an international normalized ratio (inr) > 1.5.
boolean
C0005779 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0150457 (UMLS CUI [1,3])
C0443252 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0150457 (UMLS CUI [2,3])
C0443252 (UMLS CUI [2,4])
C0043031 (UMLS CUI [3])
C0231290 (UMLS CUI [4,1])
C0040732 (UMLS CUI [4,2])
C2608320 (UMLS CUI [5,1])
C0683607 (UMLS CUI [5,2])
C0525032 (UMLS CUI [6])
Heart Disease Severe
Item
12. severe co-existing cardiac disease, characterized by any of these conditions:
boolean
C0018799 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Myocardial Infarction
Item
1. recent myocardial infarction (within past 36 weeks)
boolean
C0027051 (UMLS CUI [1])
Ischemia Heart Function Tests
Item
2. evidence of ischemia on functional cardiac exam within the last year
boolean
C0022116 (UMLS CUI [1,1])
C0018803 (UMLS CUI [1,2])
Left ventricular ejection fraction
Item
3. left ventricular ejection fraction < 30 %
boolean
C0428772 (UMLS CUI [1])
Cardiovascular Diseases
Item
4. cardiovascular conditions within 36 weeks prior to this trial:
boolean
C0007222 (UMLS CUI [1])
Decompensated cardiac failure New York Heart Association Classification | Angina, Unstable | Coronary Artery Bypass Surgery | Coronary angioplasty
Item
i. decompensated heart failure new york heart association (nyha) class iii or iv ii. unstable angina pectoris iii. coronary arterial bypass graft iv. coronary angioplasty
boolean
C0581377 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0002965 (UMLS CUI [2])
C0010055 (UMLS CUI [3])
C0190211 (UMLS CUI [4])
Increase in blood pressure Treated Inadequate | Systolic Pressure | Diastolic blood pressure
Item
13. inadequately treated blood pressure elevation (systolic bp > 160 mmhg or diastolic blood pressure > 100 mmhg)
boolean
C0497247 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C0205412 (UMLS CUI [1,3])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Antidiabetics | Exception Insulin
Item
14. use of any medications to treat diabetes other than insulin within 4 weeks of enrolment
boolean
C0935929 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0021641 (UMLS CUI [2,2])
Vaccines, Attenuated
Item
15. administration of live attenuated vaccine(s) within 8 weeks of enrolment
boolean
C0042211 (UMLS CUI [1])
Organ Transplantation
Item
16. any previous organ transplant
boolean
C0029216 (UMLS CUI [1])
Immunosuppressive Agents
Item
17. treatment with any immunosuppressive drug
boolean
C0021081 (UMLS CUI [1])
Medical condition Interferes with Study Subject Participation Status | Glucocorticoids, Systemic
Item
18. any medical condition that, in the opinion of the investigator, will interfere with safe participation in the trial (e.g., systemic glucocorticoids)
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C3540777 (UMLS CUI [2])
Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related | Hypersensitivity Suspected Pharmaceutical Preparations Related
Item
19. known or suspected allergy of hypersensitivity to trial product(s) or related products
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C0439849 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0013227 (UMLS CUI [4,3])
C0439849 (UMLS CUI [4,4])
Investigational New Drugs
Item
20. the receipt of any investigational product within 30 days of screening for this trial
boolean
C0013230 (UMLS CUI [1])
Transplantation Scheduled In addition to Islet Transplantation
Item
21. any scheduled transplant in addition to the islet transplantation
boolean
C0040732 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
C0332287 (UMLS CUI [1,3])
C0079646 (UMLS CUI [1,4])
Criteria Fulfill Pancreas Transplantation | Criteria Fulfill Islet Transplantation
Item
22. fulfillment of criteria for clinical pancreas or islet transplantation
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
C0030275 (UMLS CUI [1,3])
C0243161 (UMLS CUI [2,1])
C1550543 (UMLS CUI [2,2])
C0079646 (UMLS CUI [2,3])
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