ID

40404

Description

The I-KAN Study: Internet Insulin Education for Kansans; ODM derived from: https://clinicaltrials.gov/show/NCT01408628

Link

https://clinicaltrials.gov/show/NCT01408628

Keywords

Versions (3)
  1. 1/19/19 1/19/19 -
  2. 4/17/20 4/17/20 -
  3. 4/18/20 4/18/20 -
Copyright Holder

David Robbins, MD; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Uploaded on

April 18, 2020

DOI

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License

Creative Commons BY-NC 4.0
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Eligibility Type 2 Diabetes NCT01408628

English

Eligibility Type 2 Diabetes NCT01408628

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
t2dm, meets provider criteria for insulin initiation
Description

Diabetes mellitus type 2 | Insulin initiation indication

Data type

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0021641
UMLS CUI [2,2]
C1704686
UMLS CUI [2,3]
C3146298
starting or having started insulin treatment no longer than six months prior to enrollment or has not yet committed to starting insulin but has agreed to participate in the education
Description

Recent insulin initation | Insulin was not started yet but Agreed to insulin administration education

Data type

boolean

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C0021641
UMLS CUI [1,3]
C1704686
UMLS CUI [2,1]
C1444646
UMLS CUI [2,2]
C0021641
UMLS CUI [2,3]
C1161041
UMLS CUI [2,4]
C3641827
broadband internet and experience with logging into a password-protected site (e.g., ecommerce or social networking);
Description

Access to Internet | Experience Internet Other coding | Internet commerce experience | Social network experience

Data type

boolean

Alias
UMLS CUI [1,1]
C0444454
UMLS CUI [1,2]
C0282111
UMLS CUI [2,1]
C0596545
UMLS CUI [2,2]
C0282111
UMLS CUI [2,3]
C3846158
UMLS CUI [3,1]
C0282111
UMLS CUI [3,2]
C0009431
UMLS CUI [3,3]
C0596545
UMLS CUI [4,1]
C0150775
UMLS CUI [4,2]
C0596545
ability to purchase or otherwise acquire glargine/detemir insulin and testing supplies.
Description

Acquisition ability insulin glargine | Acquisition ability insulin detemir | Acquisition ability blood glucose testing kit

Data type

boolean

Alias
UMLS CUI [1,1]
C1706701
UMLS CUI [1,2]
C0085732
UMLS CUI [1,3]
C0907402
UMLS CUI [2,1]
C1706701
UMLS CUI [2,2]
C0085732
UMLS CUI [2,3]
C0537270
UMLS CUI [3,1]
C1706701
UMLS CUI [3,2]
C0085732
UMLS CUI [3,3]
C0595310
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
use of oral glucocorticoids or second generation anti-psychotics;
Description

Oral glucocorticoids | Second generation antipsychotics

Data type

boolean

Alias
UMLS CUI [1,1]
C0017710
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C0040615
UMLS CUI [2,2]
C0079411
UMLS CUI [2,3]
C0205436
previous use of self-administered insulin more than six months prior to enrollment;
Description

Prior therapy: Insulin, self-administered

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0021641
UMLS CUI [1,3]
C0036589
gestational diabetes or other endocrine conditions causing hyperglycemia
Description

Gestational diabetes | Endocrine disease causing hyperglycemia

Data type

boolean

Alias
UMLS CUI [1]
C0085207
UMLS CUI [2,1]
C0014130
UMLS CUI [2,2]
C0678227
UMLS CUI [2,3]
C0020456
treatment for a malignant condition other than basal cell carcinoma in situ within prior two years
Description

Recent malignant disease therapy | Exception basal cell carcinoma in situ

Data type

boolean

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C0442867
UMLS CUI [1,3]
C0087111
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C0007099
renal insufficiency (ast/alt >2 or concurrent liver disease except nash);
Description

Renal insufficiency | AST | ALT | Comorbidity: Liver diesease, Exception: NASH

Data type

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2,1]
C0201899
UMLS CUI [2,2]
C0201836
UMLS CUI [3,1]
C0009488
UMLS CUI [3,2]
C0023895
UMLS CUI [3,3]
C1705847
UMLS CUI [3,4]
C3241937
pregnant or planning to become pregnant within 6 months;
Description

Pregnancy | Pregnancy, planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
hba1c < 7.0 percent or ongoing weight loss or persistent fasting hyperglycemia > 250 mg/dl
Description

hba1c | ongoing weight loss | persistent fasting hyperglycemia

Data type

boolean

Alias
UMLS CUI [1]
C0019018
UMLS CUI [2,1]
C1262477
UMLS CUI [2,2]
C0549178
UMLS CUI [3,1]
C0583513
UMLS CUI [3,2]
C0020456
UMLS CUI [3,3]
C0205322
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Similar models

Eligibility Type 2 Diabetes NCT01408628

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes mellitus type 2 | Insulin initiation indication
Item
t2dm, meets provider criteria for insulin initiation
boolean
C0011860 (UMLS CUI [1])
C0021641 (UMLS CUI [2,1])
C1704686 (UMLS CUI [2,2])
C3146298 (UMLS CUI [2,3])
Recent insulin initation | Insulin was not started yet but Agreed to insulin administration education
Item
starting or having started insulin treatment no longer than six months prior to enrollment or has not yet committed to starting insulin but has agreed to participate in the education
boolean
C0332185 (UMLS CUI [1,1])
C0021641 (UMLS CUI [1,2])
C1704686 (UMLS CUI [1,3])
C1444646 (UMLS CUI [2,1])
C0021641 (UMLS CUI [2,2])
C1161041 (UMLS CUI [2,3])
C3641827 (UMLS CUI [2,4])
Access to Internet | Experience Internet Other coding | Internet commerce experience | Social network experience
Item
broadband internet and experience with logging into a password-protected site (e.g., ecommerce or social networking);
boolean
C0444454 (UMLS CUI [1,1])
C0282111 (UMLS CUI [1,2])
C0596545 (UMLS CUI [2,1])
C0282111 (UMLS CUI [2,2])
C3846158 (UMLS CUI [2,3])
C0282111 (UMLS CUI [3,1])
C0009431 (UMLS CUI [3,2])
C0596545 (UMLS CUI [3,3])
C0150775 (UMLS CUI [4,1])
C0596545 (UMLS CUI [4,2])
Acquisition ability insulin glargine | Acquisition ability insulin detemir | Acquisition ability blood glucose testing kit
Item
ability to purchase or otherwise acquire glargine/detemir insulin and testing supplies.
boolean
C1706701 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
C0907402 (UMLS CUI [1,3])
C1706701 (UMLS CUI [2,1])
C0085732 (UMLS CUI [2,2])
C0537270 (UMLS CUI [2,3])
C1706701 (UMLS CUI [3,1])
C0085732 (UMLS CUI [3,2])
C0595310 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Oral glucocorticoids | Second generation antipsychotics
Item
use of oral glucocorticoids or second generation anti-psychotics;
boolean
C0017710 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0040615 (UMLS CUI [2,1])
C0079411 (UMLS CUI [2,2])
C0205436 (UMLS CUI [2,3])
Prior therapy: Insulin, self-administered
Item
previous use of self-administered insulin more than six months prior to enrollment;
boolean
C1514463 (UMLS CUI [1,1])
C0021641 (UMLS CUI [1,2])
C0036589 (UMLS CUI [1,3])
Gestational diabetes | Endocrine disease causing hyperglycemia
Item
gestational diabetes or other endocrine conditions causing hyperglycemia
boolean
C0085207 (UMLS CUI [1])
C0014130 (UMLS CUI [2,1])
C0678227 (UMLS CUI [2,2])
C0020456 (UMLS CUI [2,3])
Recent malignant disease therapy | Exception basal cell carcinoma in situ
Item
treatment for a malignant condition other than basal cell carcinoma in situ within prior two years
boolean
C0332185 (UMLS CUI [1,1])
C0442867 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C0007099 (UMLS CUI [2,3])
Renal insufficiency | AST | ALT | Comorbidity: Liver diesease, Exception: NASH
Item
renal insufficiency (ast/alt >2 or concurrent liver disease except nash);
boolean
C1565489 (UMLS CUI [1])
C0201899 (UMLS CUI [2,1])
C0201836 (UMLS CUI [2,2])
C0009488 (UMLS CUI [3,1])
C0023895 (UMLS CUI [3,2])
C1705847 (UMLS CUI [3,3])
C3241937 (UMLS CUI [3,4])
Pregnancy | Pregnancy, planned
Item
pregnant or planning to become pregnant within 6 months;
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
hba1c | ongoing weight loss | persistent fasting hyperglycemia
Item
hba1c < 7.0 percent or ongoing weight loss or persistent fasting hyperglycemia > 250 mg/dl
boolean
C0019018 (UMLS CUI [1])
C1262477 (UMLS CUI [2,1])
C0549178 (UMLS CUI [2,2])
C0583513 (UMLS CUI [3,1])
C0020456 (UMLS CUI [3,2])
C0205322 (UMLS CUI [3,3])
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