ID

37289

Description

Combined Basal-bolus Insulin and Post-exercise Carbohydrate Feeding Strategy in T1DM; ODM derived from: https://clinicaltrials.gov/show/NCT02204839

Link

https://clinicaltrials.gov/show/NCT02204839

Keywords

Versions (1)
  1. 7/14/19 7/14/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 14, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 1 Diabetes Mellitus NCT02204839

English

Eligibility Type 1 Diabetes Mellitus NCT02204839

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
aged between 18-50 years old (male or female).
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
free from any diabetes related complications (apart from mild background diabetic retinopathy).
Description

Free of Complications of Diabetes Mellitus | Exception Nonproliferative diabetic retinopathy Mild

Data type

boolean

Alias
UMLS CUI [1,1]
C0332296
UMLS CUI [1,2]
C0342257
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0004606
UMLS CUI [2,3]
C2945599
hba1c <8.5%.
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
not taking any prescribed medication other than insulin, and treated with a stable insulin regimen composed of a combination of slow/long acting insulin (glargine or detemir) and fast-acting insulin analogues (lispro or aspart), for a minimum of 6 months before the start of the study.
Description

Absence Prescribed medication Except Insulin | Insulin regime Stable | Combined Modality Therapy | Insulin, Long-Acting | Insulin Glargine | Insulin detemir | Short-Acting Insulin Analogue | Insulin Lispro | Insulin Aspart

Data type

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C2239117
UMLS CUI [1,3]
C0332300
UMLS CUI [1,4]
C0021641
UMLS CUI [2,1]
C0557978
UMLS CUI [2,2]
C0205360
UMLS CUI [3]
C0009429
UMLS CUI [4]
C0304870
UMLS CUI [5]
C0907402
UMLS CUI [6]
C0537270
UMLS CUI [7,1]
C0356365
UMLS CUI [7,2]
C0243071
UMLS CUI [8]
C0293359
UMLS CUI [9]
C1708521
demonstrate normal cardiac function in response to exercise.
Description

Cardiac function test normal | Response to exercise

Data type

boolean

Alias
UMLS CUI [1]
C0438176
UMLS CUI [2]
C2265833
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
aged younger than 18, or older than 50 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
suffering from, or diagnosed with a diabetes related complication (apart from mild background diabetic retinopathy).
Description

Complications of Diabetes Mellitus | Exception Nonproliferative diabetic retinopathy Mild

Data type

boolean

Alias
UMLS CUI [1]
C0342257
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0004606
UMLS CUI [2,3]
C2945599
hba1c >8.5%.
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
currently taking prescribed medication, and not currently treated with a stable basal bolus regimen composed of a combination glargine or determir, and lispro or aspart for at least 6 months before the start of the study.
Description

Prescribed medication | Absence Insulin regime Stable | Combined Modality Therapy Absent | Insulin Glargine Absent | Insulin detemir Absent | Insulin Lispro Absent | Insulin Aspart Absent

Data type

boolean

Alias
UMLS CUI [1]
C2239117
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0557978
UMLS CUI [2,3]
C0205360
UMLS CUI [3,1]
C0009429
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0907402
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0537270
UMLS CUI [5,2]
C0332197
UMLS CUI [6,1]
C0293359
UMLS CUI [6,2]
C0332197
UMLS CUI [7,1]
C1708521
UMLS CUI [7,2]
C0332197
failure to demonstrate normal cardiopulmonary responses during exercise, or have a medical condition which could prevent completion of exercise or be exacerbated because of.
Description

Exercise | Response Cardiopulmonary failed | Medical condition Preventing Completion Exercise | Medical condition Exacerbation Due to Exercise

Data type

boolean

Alias
UMLS CUI [1]
C0015259
UMLS CUI [2,1]
C1704632
UMLS CUI [2,2]
C0553534
UMLS CUI [2,3]
C0231175
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C1292733
UMLS CUI [3,3]
C0205197
UMLS CUI [3,4]
C0015259
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C4086268
UMLS CUI [4,3]
C0678226
UMLS CUI [4,4]
C0015259
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Similar models

Eligibility Type 1 Diabetes Mellitus NCT02204839

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
aged between 18-50 years old (male or female).
boolean
C0001779 (UMLS CUI [1])
Free of Complications of Diabetes Mellitus | Exception Nonproliferative diabetic retinopathy Mild
Item
free from any diabetes related complications (apart from mild background diabetic retinopathy).
boolean
C0332296 (UMLS CUI [1,1])
C0342257 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0004606 (UMLS CUI [2,2])
C2945599 (UMLS CUI [2,3])
Hemoglobin A1c measurement
Item
hba1c <8.5%.
boolean
C0474680 (UMLS CUI [1])
Absence Prescribed medication Except Insulin | Insulin regime Stable | Combined Modality Therapy | Insulin, Long-Acting | Insulin Glargine | Insulin detemir | Short-Acting Insulin Analogue | Insulin Lispro | Insulin Aspart
Item
not taking any prescribed medication other than insulin, and treated with a stable insulin regimen composed of a combination of slow/long acting insulin (glargine or detemir) and fast-acting insulin analogues (lispro or aspart), for a minimum of 6 months before the start of the study.
boolean
C0332197 (UMLS CUI [1,1])
C2239117 (UMLS CUI [1,2])
C0332300 (UMLS CUI [1,3])
C0021641 (UMLS CUI [1,4])
C0557978 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C0009429 (UMLS CUI [3])
C0304870 (UMLS CUI [4])
C0907402 (UMLS CUI [5])
C0537270 (UMLS CUI [6])
C0356365 (UMLS CUI [7,1])
C0243071 (UMLS CUI [7,2])
C0293359 (UMLS CUI [8])
C1708521 (UMLS CUI [9])
Cardiac function test normal | Response to exercise
Item
demonstrate normal cardiac function in response to exercise.
boolean
C0438176 (UMLS CUI [1])
C2265833 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Age
Item
aged younger than 18, or older than 50 years.
boolean
C0001779 (UMLS CUI [1])
Complications of Diabetes Mellitus | Exception Nonproliferative diabetic retinopathy Mild
Item
suffering from, or diagnosed with a diabetes related complication (apart from mild background diabetic retinopathy).
boolean
C0342257 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0004606 (UMLS CUI [2,2])
C2945599 (UMLS CUI [2,3])
Hemoglobin A1c measurement
Item
hba1c >8.5%.
boolean
C0474680 (UMLS CUI [1])
Prescribed medication | Absence Insulin regime Stable | Combined Modality Therapy Absent | Insulin Glargine Absent | Insulin detemir Absent | Insulin Lispro Absent | Insulin Aspart Absent
Item
currently taking prescribed medication, and not currently treated with a stable basal bolus regimen composed of a combination glargine or determir, and lispro or aspart for at least 6 months before the start of the study.
boolean
C2239117 (UMLS CUI [1])
C0332197 (UMLS CUI [2,1])
C0557978 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0009429 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0907402 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0537270 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0293359 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C1708521 (UMLS CUI [7,1])
C0332197 (UMLS CUI [7,2])
Exercise | Response Cardiopulmonary failed | Medical condition Preventing Completion Exercise | Medical condition Exacerbation Due to Exercise
Item
failure to demonstrate normal cardiopulmonary responses during exercise, or have a medical condition which could prevent completion of exercise or be exacerbated because of.
boolean
C0015259 (UMLS CUI [1])
C1704632 (UMLS CUI [2,1])
C0553534 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C1292733 (UMLS CUI [3,2])
C0205197 (UMLS CUI [3,3])
C0015259 (UMLS CUI [3,4])
C3843040 (UMLS CUI [4,1])
C4086268 (UMLS CUI [4,2])
C0678226 (UMLS CUI [4,3])
C0015259 (UMLS CUI [4,4])
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