ID

38835

Description

A Study Evaluating the Perception of Insertion Pain With Accu-Chek FlexLink and FlexLink Plus Insulin Pump Devices Under Real Life Conditions in Diabetic Patients.; ODM derived from: https://clinicaltrials.gov/show/NCT02103595

Link

https://clinicaltrials.gov/show/NCT02103595

Keywords

Versions (1)
  1. 11/8/19 11/8/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 8, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1 NCT02103595

English

Eligibility Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1 NCT02103595

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and female subjects at least 18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
diabetes mellitus type 1 or type 2
Description

Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0011860
continuous subcutaneous insulin therapy (csii) for at least 3 months
Description

Continuous subcutaneous infusion of insulin

Data type

boolean

Alias
UMLS CUI [1]
C0393124
insulin pump compatible with luer lock infusion set (accu-chek, disetronic, animas, deltec cozmo and minimed 506 to 508)
Description

Insulin pump Consistent with Luer Lock Syringes | Accu-Chek Complete Kit | CARTRIDGE,DISETRONIC | CARTRIDGE,ANIMAS | Other Coding

Data type

boolean

Alias
UMLS CUI [1,1]
C1140609
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C0728266
UMLS CUI [2]
C0724905
UMLS CUI [3]
C1874734
UMLS CUI [4]
C1874733
UMLS CUI [5]
C3846158
sufficient potential infusion sites suitable for the usage of a cannula length of 8 mm and a tubing length of 70 and 80 cm
Description

Infusion Site Suitable Cannula | Infusion Site Suitable Tubing | Use of Cannula Length | Use of Tubing Length

Data type

boolean

Alias
UMLS CUI [1,1]
C2697750
UMLS CUI [1,2]
C3900053
UMLS CUI [1,3]
C0520453
UMLS CUI [2,1]
C2697750
UMLS CUI [2,2]
C3900053
UMLS CUI [2,3]
C0184165
UMLS CUI [3,1]
C1524063
UMLS CUI [3,2]
C0520453
UMLS CUI [3,3]
C1444754
UMLS CUI [4,1]
C1524063
UMLS CUI [4,2]
C0184165
UMLS CUI [4,3]
C1444754
willing to measure blood glucose at least 4 times per day and 1-3 hrs after each new insertion
Description

Blood glucose measurement times per day

Data type

boolean

Alias
UMLS CUI [1,1]
C0392201
UMLS CUI [1,2]
C0439511
willing and able to participate and comply with study procedures including the general recommendation of shifting infusion sets (at least every 3 days)
Description

Participation Willing | Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0600109
UMLS CUI [2]
C0525058
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
significantly impaired awareness of hypoglycemia
Description

Loss of hypoglycemic warning

Data type

boolean

Alias
UMLS CUI [1]
C0342317
a history of or high risk of ketoacidosis during csii therapy
Description

Ketoacidosis | High risk of Ketoacidosis

Data type

boolean

Alias
UMLS CUI [1]
C0220982
UMLS CUI [2,1]
C0332167
UMLS CUI [2,2]
C0220982
frequent catheter abscesses in the past year, as per investigator´s discretion
Description

Catheter site abscess Frequent

Data type

boolean

Alias
UMLS CUI [1,1]
C3267041
UMLS CUI [1,2]
C0332183
known strong plaster incompatibility and/or allergy (history of catheter use)
Description

Plaster Incompatibility | Hypersensitivity Plaster | Relationship Use of Catheter

Data type

boolean

Alias
UMLS CUI [1,1]
C0460977
UMLS CUI [1,2]
C0920399
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0460977
UMLS CUI [3,1]
C0439849
UMLS CUI [3,2]
C1524063
UMLS CUI [3,3]
C0085590
unstable chronic disease other than diabetes
Description

Chronic disease Unstable | Exception Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1,1]
C0008679
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0011849
chronic use of steroids in adrenal suppressive doses, other immuno-modulatory medication or chemotherapy
Description

Steroid use chronic | Biological Response Modifiers | Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0281991
UMLS CUI [1,2]
C0205191
UMLS CUI [2]
C0005525
UMLS CUI [3]
C0392920
acute illness or abnormality at the time of screening rendering the patient not suitable to participate in the study in the opinion of the investigator
Description

Illness Study Subject Participation Status Inappropriate | Abnormality Study Subject Participation Status Inappropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1548788
UMLS CUI [2,1]
C1704258
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C1548788
chronic use of analgesics and any other condition interfering with the assessment of pain, as per investigator´s discretion
Description

Analgesics chronic | Condition Interferes with Pain Assessment

Data type

boolean

Alias
UMLS CUI [1,1]
C0002771
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0030198
are either pregnant or breastfeeding or are currently planning a pregnancy
Description

Pregnancy | Breast Feeding | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
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Similar models

Eligibility Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1 NCT02103595

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male and female subjects at least 18 years of age
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent
Item
diabetes mellitus type 1 or type 2
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
Continuous subcutaneous infusion of insulin
Item
continuous subcutaneous insulin therapy (csii) for at least 3 months
boolean
C0393124 (UMLS CUI [1])
Insulin pump Consistent with Luer Lock Syringes | Accu-Chek Complete Kit | CARTRIDGE,DISETRONIC | CARTRIDGE,ANIMAS | Other Coding
Item
insulin pump compatible with luer lock infusion set (accu-chek, disetronic, animas, deltec cozmo and minimed 506 to 508)
boolean
C1140609 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0728266 (UMLS CUI [1,3])
C0724905 (UMLS CUI [2])
C1874734 (UMLS CUI [3])
C1874733 (UMLS CUI [4])
C3846158 (UMLS CUI [5])
Infusion Site Suitable Cannula | Infusion Site Suitable Tubing | Use of Cannula Length | Use of Tubing Length
Item
sufficient potential infusion sites suitable for the usage of a cannula length of 8 mm and a tubing length of 70 and 80 cm
boolean
C2697750 (UMLS CUI [1,1])
C3900053 (UMLS CUI [1,2])
C0520453 (UMLS CUI [1,3])
C2697750 (UMLS CUI [2,1])
C3900053 (UMLS CUI [2,2])
C0184165 (UMLS CUI [2,3])
C1524063 (UMLS CUI [3,1])
C0520453 (UMLS CUI [3,2])
C1444754 (UMLS CUI [3,3])
C1524063 (UMLS CUI [4,1])
C0184165 (UMLS CUI [4,2])
C1444754 (UMLS CUI [4,3])
Blood glucose measurement times per day
Item
willing to measure blood glucose at least 4 times per day and 1-3 hrs after each new insertion
boolean
C0392201 (UMLS CUI [1,1])
C0439511 (UMLS CUI [1,2])
Participation Willing | Protocol Compliance
Item
willing and able to participate and comply with study procedures including the general recommendation of shifting infusion sets (at least every 3 days)
boolean
C0679823 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Loss of hypoglycemic warning
Item
significantly impaired awareness of hypoglycemia
boolean
C0342317 (UMLS CUI [1])
Ketoacidosis | High risk of Ketoacidosis
Item
a history of or high risk of ketoacidosis during csii therapy
boolean
C0220982 (UMLS CUI [1])
C0332167 (UMLS CUI [2,1])
C0220982 (UMLS CUI [2,2])
Catheter site abscess Frequent
Item
frequent catheter abscesses in the past year, as per investigator´s discretion
boolean
C3267041 (UMLS CUI [1,1])
C0332183 (UMLS CUI [1,2])
Plaster Incompatibility | Hypersensitivity Plaster | Relationship Use of Catheter
Item
known strong plaster incompatibility and/or allergy (history of catheter use)
boolean
C0460977 (UMLS CUI [1,1])
C0920399 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0460977 (UMLS CUI [2,2])
C0439849 (UMLS CUI [3,1])
C1524063 (UMLS CUI [3,2])
C0085590 (UMLS CUI [3,3])
Chronic disease Unstable | Exception Diabetes Mellitus
Item
unstable chronic disease other than diabetes
boolean
C0008679 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0011849 (UMLS CUI [2,2])
Steroid use chronic | Biological Response Modifiers | Chemotherapy
Item
chronic use of steroids in adrenal suppressive doses, other immuno-modulatory medication or chemotherapy
boolean
C0281991 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0005525 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
Illness Study Subject Participation Status Inappropriate | Abnormality Study Subject Participation Status Inappropriate
Item
acute illness or abnormality at the time of screening rendering the patient not suitable to participate in the study in the opinion of the investigator
boolean
C0221423 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
C1704258 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1548788 (UMLS CUI [2,3])
Analgesics chronic | Condition Interferes with Pain Assessment
Item
chronic use of analgesics and any other condition interfering with the assessment of pain, as per investigator´s discretion
boolean
C0002771 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0030198 (UMLS CUI [2,3])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
are either pregnant or breastfeeding or are currently planning a pregnancy
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
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