Evidence Based Medicine on FHIR Implementation Guide
2.0.0-ballot - ballot
Evidence Based Medicine on FHIR Implementation Guide
2.0.0-ballot - ballot
Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 2.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions
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value="M11 IGBJ Protocol Example Eligibility Criteria [Database Entry: FHIR Group Resource]. Contributors: Brian S. Alper [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 267506. Revised 2024-09-29. Available at: https://fevir.net/resources/Group/267506. Computable resource at: https://fevir.net/resources/Group/267506."/>
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<description
value="**Inclusion Criteria**
Patients are eligible for inclusion in the study only if they meet all of the following criteria at screening and/or enrollment:
1. Meet either T1DM-specific eligibility criteria or T2DM-specific eligibility criteria
.a. T1DM-specific criteria
..i. Diagnosis of T1DM based on the World Health Organization (WHO) diagnostic criteria
..ii. have been on the following daily insulin therapy for at least 1 year
...1) multiple daily injection of long-acting insulin analog (either insulin glargine [U-100 or U-300] or insulin degludec [U-100]) and rapid-acting insulin analog (insulin lispro, insulin aspart, or insulin glulisine), or
...2) continuous subcutaneous insulin infusion (CSII)
..iii. are between 18 and 64 years old at the time of informed consent
..iv. have a body mass index of 18.5 to 30.0 kg/m2 at the time of screening
.b. T2DM-specific criteria
..i. Diagnosis of T2DM based on the World Health Organization (WHO) diagnostic criteria
..ii. have received the following daily insulin therapy with or without oral anti-hyperglycemic medications (OAMs) for at least 1 year
...1) insulin: long-acting insulin analog (either insulin glargine [U-100 or U-300] or insulin degludec [U-100]) alone, or in combination with rapid-acting insulin analog (insulin lispro, insulin aspart, or insulin glulisine) or CSII
...2) OAM: up to 3 of the following OAMs in accordance with local regulations: metformin, dipeptidyl peptidase-4 inhibitor, sodium glucose cotransporter 2 inhibitor, sulfonylurea (should not be more than half of maximum approved doses), glinides, alpha-glucosidase inhibitor, or thiazolidine
..iii. are between 20 and 70 years old at the time of informed consent
..iv. have a body mass index of 18.5 to 35.0 kg/m2 at the time of screening
2. have a hemoglobin A1c value ≤10% at the time of screening
3. agree to use an effective method of contraception, defined by study protocol
4. have clinical laboratory test results within normal reference range (except for glycemic parameters) for the population or investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
5. have venous access sufficient to allow for blood sampling and administration of insulin for IV administration as per the protocol
6. are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
7. are able and willing to give signed informed consent.
**Exclusion Criteria**
Patients will be excluded from study enrollment if they meet any of the following criteria at screening and/or enrollment:
1. are investigative site personnel directly affiliated with this study and their immediate families. Immediate family is defined as a spouse, biological or legal guardian, child, or sibling
2. are Lilly employees
3. are currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
4. have participated, within the last 4 months, in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 4 months or 5 half-lives (whichever is longer) should have passed from the last dose of investigational product
5. have previously completed or withdrawn from this study or any other study investigating LY900018, and have previously received LY900018
6. have known allergies or sensitivity to LY900018, glucagon, related compounds, or any components of the formulation, or history of significant atopy
7. have an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risks associated with participating in the study
8. any significant changes in insulin regimen and/or unstable blood glucose control within the past 3 months prior to screening as assessed by the investigator
9. have received a total daily dose of insulin >1.2 U/kg at the time of screening
10. have poorly controlled hypertension (ie, supine systolic BP >165 mm Hg or supine diastolic BP >95 mm Hg) at screening, or a change in antihypertensive medications within 30 days prior to screening
11. have a history of pheochromocytoma (ie, adrenal gland tumor) or insulinoma
12. have a history of an episode of severe hypoglycemia (as defined by an episode that required third party assistance for treatment) in the 1 month prior to screening or have a history of loss of consciousness within the last 2 years induced other than by hypoglycemia
13. have a history of epilepsy or seizure disorder
14. have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (apart from T1DM or T2DM), hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data
15. have known or ongoing psychiatric disorders that, in the opinion of the investigator, may preclude the patient from following and completing the protocol
16. regularly use known drugs of abuse and/or show positive findings on urinary drug screening
17. show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies and/or antigen
18. show evidence of hepatitis C and/or positive hepatitis C antibody
19. show evidence of hepatitis B and/or positive hepatitis B surface antigen
20. show evidence of syphilis and/or are positive for syphilis test
21. are women who are lactating
22. use of daily systemic beta-blocker, indomethacin, warfarin, anticholinergic drugs
23. have donated 400 mL or more blood in the last 12 weeks (males) or in the last 16 weeks (females), or any blood donation (including apheresis) within the last 4 weeks, or total volume of blood donation within 12 months is 1200 mL (males)/800 mL (females) or more at screening
24. have an average weekly alcohol intake that exceeds 21 units per week (males up to age 65) and 14 units per week (males over 65 and females), or are unwilling to stop alcohol consumption from Day -2 to discharge from CRU in each period (1 unit = 12 oz or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits)
25. in the opinion of the investigator or sponsor, are unsuitable for inclusion in the study
26. have pre-proliferative and proliferative retinopathy or maculopathy requiring treatment or not clinically stable in the last 6 months, or patients with active changes in subjective eye symptoms as determined by the investigator if an eye exam has not been performed in the last 6 months. Note: If an eye examination has been performed no more than 6 months before screening, it will not have to be repeated; however, the investigator will need to confirm via interview that there is no change in subjective symptoms."/>
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value="Meet either T1DM-specific eligibility criteria or T2DM-specific eligibility criteria
a. T1DM-specific criteria
..i. Diagnosis of T1DM based on the World Health Organization (WHO) diagnostic criteria
..ii. have been on the following daily insulin therapy for at least 1 year
...1) multiple daily injection of long-acting insulin analog (either insulin glargine [U-100 or U-300] or insulin degludec [U-100]) and rapid-acting insulin analog (insulin lispro, insulin aspart, or insulin glulisine), or
...2) continuous subcutaneous insulin infusion (CSII)
..iii. are between 18 and 64 years old at the time of informed consent
..iv. have a body mass index of 18.5 to 30.0 kg/m2 at the time of screening
b. T2DM-specific criteria
..i. Diagnosis of T2DM based on the World Health Organization (WHO) diagnostic criteria
..ii. have received the following daily insulin therapy with or without oral anti-hyperglycemic medications (OAMs) for at least 1 year
...1) insulin: long-acting insulin analog (either insulin glargine [U-100 or U-300] or insulin degludec [U-100]) alone, or in combination with rapid-acting insulin analog (insulin lispro, insulin aspart, or insulin glulisine) or CSII
...2) OAM: up to 3 of the following OAMs in accordance with local regulations: metformin, dipeptidyl peptidase-4 inhibitor, sodium glucose cotransporter 2 inhibitor, sulfonylurea (should not be more than half of maximum approved doses), glinides, alpha-glucosidase inhibitor, or thiazolidine
..iii. are between 20 and 70 years old at the time of informed consent
..iv. have a body mass index of 18.5 to 35.0 kg/m2 at the time of screening"/>
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<comparator value="<="/>
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<text value="Agree to not reproduce per study protocol"/>
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<exclude value="false"/>
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value="Agree to not reproduce:
. for male patients: agree to use an effective method of contraception for the duration of the study and for 28 days following the last study treatment
. for female patients:
.. a. women of childbearing potential who are abstinent (if this is complete abstinence, as their preferred and usual lifestyle) or in a same sex relationship (as part of their preferred and usual lifestyle) must agree to either remain abstinent or stay in a same sex relationship without sexual relationships with males. Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence just for the duration of a trial, and withdrawal are not acceptable methods of contraception.
.. b. otherwise, women of childbearing potential participating must agree to use one highly effective method (less than 1% failure rate) of contraception, or a combination of 2 effective methods of contraception for the entirety of the study.
... i. women of childbearing potential participating must test negative for pregnancy prior to initiation of treatment as indicated by a negative serum pregnancy test at the screening visit followed by a negative urine pregnancy test within 24 hours prior to exposure.
... ii. either one highly effective method of contraception or a combination of 2 effective methods of contraception will be used. The patient may choose to use a double barrier method of contraception. Barrier protection methods without concomitant use of a spermicide are not a reliable or acceptable method. Thus, each barrier method must include use of a spermicide. It should be noted that the use of male and female condoms as a double barrier method is not considered acceptable due to the high failure rate when these methods are combined.
.. c. women not of childbearing potential may participate, and include those who are:
... i. infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation), congenital anomaly such as mullerian agenesis Or
... ii. postmenopausal, defined as either:
.... 1. a woman at least 50 years of age with an intact uterus, not on hormone therapy, who has had either: a. cessation of menses for at least 1 year, or b. at least 6 months of spontaneous amenorrhea with a follicle-stimulating hormone >40 mIU/mL; or
.... 2. a woman 55 or older not on hormone therapy, who has had at least 6 months of spontaneous amenorrhea, or
.... 3. a woman at least 55 years of age with a diagnosis of menopause prior to starting hormone replacement therapy"/>
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<exclude value="false"/>
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<characteristic>
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<text
value="are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures"/>
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<exclude value="false"/>
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<exclude value="true"/>
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</characteristic>
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<text value="Lilly"/>
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<exclude value="true"/>
<description value="are Lilly employees"/>
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<characteristic>
<code>
<text value="Defined by CodeableConcept"/>
</code>
<valueCodeableConcept>
<text
value="are currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study"/>
</valueCodeableConcept>
<exclude value="true"/>
<description
value="are currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study"/>
</characteristic>
<characteristic>
<code>
<text value="Defined by CodeableConcept"/>
</code>
<valueCodeableConcept>
<text
value="have participated, within the last 4 months, in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 4 months or 5 half-lives (whichever is longer) should have passed from the last dose of investigational product"/>
</valueCodeableConcept>
<exclude value="true"/>
<description
value="have participated, within the last 4 months, in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 4 months or 5 half-lives (whichever is longer) should have passed from the last dose of investigational product"/>
</characteristic>
<characteristic>
<code>
<text value="Defined by CodeableConcept"/>
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<valueCodeableConcept>
<text
value="have previously completed or withdrawn from this study or any other study investigating LY900018, and have previously received LY900018"/>
</valueCodeableConcept>
<exclude value="true"/>
<description
value="have previously completed or withdrawn from this study or any other study investigating LY900018, and have previously received LY900018"/>
</characteristic>
<characteristic>
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<text value="Defined by CodeableConcept"/>
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<valueCodeableConcept>
<text
value="have known allergies or sensitivity to LY900018, glucagon, related compounds, or any components of the formulation, or history of significant atopy"/>
</valueCodeableConcept>
<exclude value="true"/>
<description
value="have known allergies or sensitivity to LY900018, glucagon, related compounds, or any components of the formulation, or history of significant atopy"/>
</characteristic>
<characteristic>
<code>
<text value="Defined by CodeableConcept"/>
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<valueCodeableConcept>
<text
value="have an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risks associated with participating in the study"/>
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<exclude value="true"/>
<description
value="have an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risks associated with participating in the study"/>
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<characteristic>
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value="significant change in insulin regimen and/or unstable blood glucose control"/>
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<exclude value="true"/>
<description
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<characteristic>
<code>
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<valueQuantity>
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<comparator value=">"/>
<unit value="U/kg"/>
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<exclude value="true"/>
<description
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<characteristic>
<code>
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</valueCodeableConcept>
<exclude value="true"/>
<description
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<code>
<coding>
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<description
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<exclude value="true"/>
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<code>
<coding>
<system value="http://snomed.info/sct"/>
<code value="64572001"/>
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<valueCodeableConcept>
<text value="epilepsy or seizure disorder"/>
</valueCodeableConcept>
<exclude value="true"/>
<description value="have a history of epilepsy or seizure disorder"/>
</characteristic>
<characteristic>
<code>
<text value="Defined by CodeableConcept"/>
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<valueCodeableConcept>
<text
value="have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (apart from T1DM or T2DM), hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data"/>
</valueCodeableConcept>
<exclude value="true"/>
<description
value="have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (apart from T1DM or T2DM), hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data"/>
</characteristic>
<characteristic>
<code>
<text value="Defined by CodeableConcept"/>
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value="have known or ongoing psychiatric disorders that, in the opinion of the investigator, may preclude the patient from following and completing the protocol"/>
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<exclude value="true"/>
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<characteristic>
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<exclude value="true"/>
<description
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</characteristic>
<characteristic>
<code>
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<text
value="show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies and/or antigen"/>
</valueCodeableConcept>
<exclude value="true"/>
<description
value="show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies and/or antigen"/>
</characteristic>
<characteristic>
<code>
<text value="Defined by CodeableConcept"/>
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<valueCodeableConcept>
<text
value="show evidence of hepatitis C and/or positive hepatitis C antibody"/>
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<exclude value="true"/>
<description
value="show evidence of hepatitis C and/or positive hepatitis C antibody"/>
</characteristic>
<characteristic>
<code>
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<text
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</valueCodeableConcept>
<exclude value="true"/>
<description
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</characteristic>
<characteristic>
<code>
<text value="Defined by CodeableConcept"/>
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<valueCodeableConcept>
<text
value="show evidence of syphilis and/or are positive for syphilis test"/>
</valueCodeableConcept>
<exclude value="true"/>
<description
value="show evidence of syphilis and/or are positive for syphilis test"/>
</characteristic>
<characteristic>
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<coding>
<system value="http://snomed.info/sct"/>
<code value="260905004"/>
<display value="Condition"/>
</coding>
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<valueCodeableConcept>
<text value="Lactating"/>
</valueCodeableConcept>
<exclude value="true"/>
<description value="are women who are lactating"/>
</characteristic>
<characteristic>
<code>
<coding>
<system value="http://hl7.org/fhir/fhir-types"/>
<code value="MedicationRequest"/>
<display value="MedicationRequest"/>
</coding>
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<valueCodeableConcept>
<text
value="use of daily systemic beta-blocker, indomethacin, warfarin, anticholinergic drugs"/>
</valueCodeableConcept>
<exclude value="true"/>
<description
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</characteristic>
<characteristic>
<code>
<text value="Defined by CodeableConcept"/>
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<valueCodeableConcept>
<text
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</valueCodeableConcept>
<exclude value="true"/>
<description
value="have an average weekly alcohol intake that exceeds 21 units per week (males up to age 65) and 14 units per week (males over 65 and females), or are unwilling to stop alcohol consumption from Day -2 to discharge from CRU in each period (1 unit = 12 oz or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits)"/>
</characteristic>
<characteristic>
<code>
<text value="Defined by CodeableConcept"/>
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<valueCodeableConcept>
<text
value="in the opinion of the investigator or sponsor, are unsuitable for inclusion in the study"/>
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<exclude value="true"/>
<description
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</characteristic>
<characteristic>
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<valueCodeableConcept>
<text
value="have pre-proliferative and proliferative retinopathy or maculopathy requiring treatment or not clinically stable in the last 6 months, or patients with active changes in subjective eye symptoms as determined by the investigator if an eye exam has not been performed in the last 6 months. Note: If an eye examination has been performed no more than 6 months before screening, it will not have to be repeated; however, the investigator will need to confirm via interview that there is no change in subjective symptoms."/>
</valueCodeableConcept>
<exclude value="true"/>
<description
value="have pre-proliferative and proliferative retinopathy or maculopathy requiring treatment or not clinically stable in the last 6 months, or patients with active changes in subjective eye symptoms as determined by the investigator if an eye exam has not been performed in the last 6 months. Note: If an eye examination has been performed no more than 6 months before screening, it will not have to be repeated; however, the investigator will need to confirm via interview that there is no change in subjective symptoms."/>
</characteristic>
</Group>
IG © 2024+ HL7 International / Clinical Decision Support. Package hl7.fhir.uv.ebm#2.0.0-ballot based on FHIR 6.0.0-ballot2. Generated 2024-12-19
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