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  1. 1. Clinical Trial
  2. 2. Routine Documentation
  3. 3. Registry/Cohort Study
  4. 4. Quality Assurance
  5. 5. Data Standard
  6. 6. Patient-Reported Outcome
  7. 7. Medical Specialty
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Eligibility Type 2 Diabetes NCT00479973

- 9/27/21 - 1 form, 2 itemgroups, 14 items, 1 language
Itemgroups: Inclusion Criteria,Exclusion Criteria
The Anti-Diabetic and Cholesterol-Lowering Effects of Cinnamon and Cassia Bark; ODM derived from: https://clinicaltrials.gov/show/NCT00479973

Eligibility Diabetes NCT02210871

- 9/27/21 - 1 form, 2 itemgroups, 8 items, 1 language
Itemgroups: Inclusion Criteria,Exclusion Criteria
Investigating the Pharmacokinetics, Safety and Tolerability After a Single Subcutaneous Injection of Semaglutide in Subjects With Mild, Moderate or Severe Hepatic Impairment Compared to Subjects With Normal Hepatic Function; ODM derived from: https://clinicaltrials.gov/show/NCT02210871

Eligibility Diabetes Mellitus, Type 2 NCT02420392

- 9/27/21 - 1 form, 2 itemgroups, 19 items, 1 language
Itemgroups: Inclusion Criteria,Exclusion Criteria
Effects of Dapagliflozin on the Incretin Sensitivity of the Pancreatic Beta Cell; ODM derived from: https://clinicaltrials.gov/show/NCT02420392

Eligibility Diabetes NCT01028404

- 9/27/21 - 1 form, 2 itemgroups, 16 items, 1 language
Itemgroups: Inclusion Criteria,Exclusion Criteria
A Two Part Trial Investigating NN1952 in Healthy Subjects and Subjects With Type 1 and Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01028404

Eligibility Diabetes Mellitus NCT02310555

- 9/27/21 - 1 form, 2 itemgroups, 14 items, 1 language
Itemgroups: Inclusion Criteria,Exclusion Criteria
Surgical Techniques in Diabetes Mellitus-II and Obesity. Metabolic Surgery Study (MSS); ODM derived from: https://clinicaltrials.gov/show/NCT02310555

Eligibility Diabetes Mellitus NCT01796834

- 9/27/21 - 1 form, 2 itemgroups, 10 items, 1 language
Itemgroups: Inclusion Criteria,Exclusion Criteria
Managing Diabetes Mindfully Study; ODM derived from: https://clinicaltrials.gov/show/NCT01796834

Eligibility Obstructive Sleep Apnea and Diabetes Mellitus NCT01136785

- 9/27/21 - 1 form, 2 itemgroups, 10 items, 1 language
Itemgroups: Inclusion Criteria,Exclusion Criteria
Effects of Continuous Positive Airway Pressure (CPAP)Treatment on Glucose Control; ODM derived from: https://clinicaltrials.gov/show/NCT01136785

Eligibility New Onset Diabetes Mellitus After Renal Transplantation NCT01268995

- 9/23/21 - 1 form, 2 itemgroups, 10 items, 1 language
Itemgroups: Inclusion Criteria,Exclusion Criteria
Improving Secretion of Insulin in New Onset Diabetes After Renal Transplantation; ODM derived from: https://clinicaltrials.gov/show/NCT01268995

Eligibility Type 2 Diabetes NCT01792206

- 9/22/21 - 1 form, 2 itemgroups, 13 items, 1 language
Itemgroups: Inclusion Criteria,Exclusion Criteria
Effect Of Paricalcitol (Zemplar) On Endothelial Function And Inflammation In Type 2 Diabetes And Chronic Kidney Disease; ODM derived from: https://clinicaltrials.gov/show/NCT01792206

ICHOM Type 1 and Type 2 Diabetes in Adults - Annual Characteristics, Patient reported Form

- 9/20/21 - 1 form, 9 itemgroups, 32 items, 1 language
Itemgroups: Patient ID,Demographic Factors,Lifestyle and Social Factors,Treatment variables,Clinician-reported Outcomes: Chronic Complications,Patient reported Outcomes: Financial Barriers to Care,Patient reported Outcome: Psychological Well-being,Patient-reported outcomes: Diabetes Distress,Patient-reported outcomes: Depression
Type 1 and Type 2 Diabetes in Adults DATA COLLECTION Version 1.0.0 Revised February 28th, 2019 www.ichom.org Notice: This work was conducted using resources from ICHOM, the International Consortium for Health Outcomes Measurement (www.ICHOM.org). The content is solely the responsibility of the authors and does not necessarily represent the official views of ICHOM. Conditions: Type 1 Diabetes | Type 2 Diabetes Excluded Conditions: Diabetes mellitus types other than 1 and 2 | Secondary Diabetes | Gestational Diabetes Population: Adults Aged 18 years and Above Excluded Populations: Children and Young persons below 18 years Treatment Approaches: Non-Pharmacological Therapy | Non-Insulin-based Pharmacological Therapy | Insulin-based Pharmacological Therapy This form is for documentation of characteristics to be reported annually by the patient. If necessary (i.e. information not already on the 6-monthly clinician-reported form) please also fill in the 6-monthly patient-reported form. It is sufficient for the educational status to only be updated every 5 years. Use of the following Scores for this standard set: WHO (Five) Well-Being Index (WHO-5): The WHO-5 is free for all health care organizations, and a license is not needed. There are translations available. The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being. More information (including the WHO-5 Scoring Guide) may be found at www.who-5.org. Problem Areas in Diabetes Questionnaire (PAID): The PAID, authored by Joslin Diabetes Center (http://www.joslin.org), is the copyright of Joslin Diabetes Center (Copyright ©2000, Joslin Diabetes Center). The PAID, provided under license from Joslin Diabetes Center may not be copied, distributed or used in any way without the prior written consent of Joslin Diabetes Center. Contact Susan D. Sjostrom at Joslin Diabetes Center at: susan.sjostrom@joslin.harvard.edu for licensing details and scoring guide. Patient Health Questionnaire (PHQ-9): Copyright by Pfizer: "content found on the PHQ Screeners site is free for download and use as stated within the PHQ Screeners site", please visit http://www.phqscreeners.com/ for more information. For this standard set ICHOM was supported by Imperial College London Diabetes Centre and JDRF. Publication: Nano J, Carinci F, Okunade O, et al. A standard set of person-centred outcomes for diabetes mellitus: results of an international and unified approach. Diabetic Medicine [Internet]. [cited 2020 Mar 4];n/a(n/a). Available from: https://onlinelibrary.wiley.com/doi/abs/10.1111/dme.14286 For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Type 1 and Type 2 Diabetes in Adults - Baseline Characteristics, Patient reported Form

- 9/20/21 - 1 form, 12 itemgroups, 37 items, 1 language
Itemgroups: Patient ID,Demographic Factors,Diagnosis Profile,Lifestyle and Social Factors,Treatment variables,Clinician Reported Outcomes: Glycemic Control,Clinician Reported Outcomes: Acute Events,Clinician-reported Outcomes: Chronic Complications,Patient reported Outcomes: Financial Barriers to Care,Patient reported Outcome: Psychological Well-being,Patient-reported outcomes: Diabetes Distress,Patient-reported outcomes: Depression
Type 1 and Type 2 Diabetes in Adults DATA COLLECTION Version 1.0.0 Revised February 28th, 2019 www.ichom.org Notice: This work was conducted using resources from ICHOM, the International Consortium for Health Outcomes Measurement (www.ICHOM.org). The content is solely the responsibility of the authors and does not necessarily represent the official views of ICHOM. Conditions: Type 1 Diabetes | Type 2 Diabetes Excluded Conditions: Diabetes mellitus types other than 1 and 2 | Secondary Diabetes | Gestational Diabetes Population: Adults Aged 18 years and Above Excluded Populations: Children and Young persons below 18 years Treatment Approaches: Non-Pharmacological Therapy | Non-Insulin-based Pharmacological Therapy | Insulin-based Pharmacological Therapy This form is for documentation of baseline characteristics to be reported by the patient. Use of the following Scores for this standard set: WHO (Five) Well-Being Index (WHO-5): The WHO-5 is free for all health care organizations, and a license is not needed. There are translations available. The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being. More information (including the WHO-5 Scoring Guide) may be found at www.who-5.org. Problem Areas in Diabetes Questionnaire (PAID): The PAID, authored by Joslin Diabetes Center (http://www.joslin.org), is the copyright of Joslin Diabetes Center (Copyright ©2000, Joslin Diabetes Center). The PAID, provided under license from Joslin Diabetes Center may not be copied, distributed or used in any way without the prior written consent of Joslin Diabetes Center. Contact Susan D. Sjostrom at Joslin Diabetes Center at: susan.sjostrom@joslin.harvard.edu for licensing details and scoring guide. Patient Health Questionnaire (PHQ-9): Copyright by Pfizer: "content found on the PHQ Screeners site is free for download and use as stated within the PHQ Screeners site", please visit http://www.phqscreeners.com/ for more information. For this standard set ICHOM was supported by Imperial College London Diabetes Centre and JDRF. Publication: Nano J, Carinci F, Okunade O, et al. A standard set of person-centred outcomes for diabetes mellitus: results of an international and unified approach. Diabetic Medicine [Internet]. [cited 2020 Mar 4];n/a(n/a). Available from: https://onlinelibrary.wiley.com/doi/abs/10.1111/dme.14286 For this version of the standard set, semantic annotation with UMLS CUIs has been added.

Eligibility Insulin Resistance NCT00508937

- 9/20/21 - 1 form, 2 itemgroups, 15 items, 1 language
Itemgroups: Inclusion Criteria,Exclusion Criteria
Dietary Protein and Insulin Sensitivity Study; ODM derived from: https://clinicaltrials.gov/show/NCT00508937

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