Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot3 - STU 1 ballot
Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot3 - STU 1 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 1.0.0-ballot3 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
| Page standards status: Informative |
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<div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: Composition 568062</b></p><a name="568062"> </a><a name="hc568062"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">version: 4; Last updated: 2026-05-30 22:22:09+0000</p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-m11-report-section-05.html">M11ReportSection05</a></p></div><p><b>ArtifactPublicationStatus</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/cited-artifact-status-type active}">Active</span></p><p><b>url</b>: <a href="https://fevir.net/resources/Composition/568062">https://fevir.net/resources/Composition/568062</a></p><p><b>identifier</b>: FEvIR Object Identifier/568062</p><p><b>status</b>: Final</p><p><b>type</b>: <span title="Codes:{http://loinc.org 35528-9}">CeSHarP Report</span></p><p><b>category</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C218547}">section5-trial-population</span></p><p><b>date</b>: 2026-05-30 22:22:09+0000</p><p><b>author</b>: Brian S. Alper, MD, MSPH</p><p><b>title</b>: M11 Report Section 5 (Trial Population) for A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example</p><p><b>custodian</b>: <a href="Organization-118079.html">Computable Publishing LLC</a></p><blockquote><p><b>relatesTo</b></p><p><b>type</b>: Derived From</p><p><b>target</b>: <a href="ResearchStudy-267245.html">A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example</a></p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: Cite As</p><p><b>target</b>: </p><div><p>M11 Report Section 5 (Trial Population) for A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example [Database Entry: FHIR Composition Resource]. Contributors: Brian S. Alper, MD, MSPH [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 568062. Revised 2026-05-30. Available at: https://fevir.net/resources/Composition/568062. Computable resource at: https://fevir.net/resources/Composition/568062#json.</p>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>Seventy-five patients may be enrolled in order to have at least 66 patients (at least 30 patients with T1DM and T2DM, respectively) complete the study. For purposes of this study, a completer is defined as a patient who completes both periods with evaluable primary outcome. If patients discontinue from the study before completion of both periods with evaluable primary outcome for any reason, the patient may be replaced to ensure 66 patients complete the study. The replacement patients will be assigned the same treatment sequence as the patients to be replaced and will complete that treatment sequence in its entirety. Replacement should not occur beyond 75 patients enrolled, if it is expected to have at least 66 patients complete the study. Eligibility of patients for the study will be based on the results of screening medical history, physical examination, vital signs, clinical laboratory tests, and ECG. The nature of any conditions present at the time of the physical examination and any preexisting conditions will be documented. Screening may occur up to 28 days prior to enrollment. Patients who are not enrolled within 28 days of screening may be subjected to an additional medical assessment and/or clinical measurements to confirm their eligibility. Prospective approval of protocol deviations to recruitment and enrollment criteria, also known as protocol waivers or exemptions, are not permitted.</p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>Patients are eligible for inclusion in the study only if they meet all of the following criteria at screening and/or enrollment: </p>
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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 </p>
<p>
2. have a hemoglobin A1c value ≤10% at the time of screening </p>
<p>
3. agree to use an effective method of contraception, defined by study protocol
</p>
<p>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 </p>
<p>
5. have venous access sufficient to allow for blood sampling and administration of insulin for IV administration as per the protocol </p>
<p>
6. are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures </p>
<p>
7. are able and willing to give signed informed consent.
</p><p> </p><p>As structured eligibility criteria:</p><p>1. <strong>Characteristic: </strong>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; <strong>Defined as: </strong>Defined by Reference matching value of CohortDefinition: Meet either T1DM-specific eligibility criteria or T2DM-specific eligibility criteria</p>
<p>2. <strong>Characteristic: </strong>have a hemoglobin A1c value ≤10% at the time of screening ; <strong>Defined as: </strong>Hemoglobin A1c/Hemoglobin.total standardized per IFCC-RMP for CDT in Blood (LOINC code: 59261-8) matching value of ≤ 10.000 %</p>
<p>3. <strong>Characteristic: </strong>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 ; <strong>Defined as: </strong>Defined by CodeableConcept matching value of Agree to not reproduce per study protocol</p>
<p>4. <strong>Characteristic: </strong>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; <strong>Defined as: </strong>Defined by CodeableConcept matching value of 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</p>
<p>5. <strong>Characteristic: </strong>have venous access sufficient to allow for blood sampling and administration of insulin for IV administration as per the protocol; <strong>Defined as: </strong>Defined by CodeableConcept matching value of have venous access sufficient to allow for blood sampling and administration of insulin for IV administration as per the protocol</p>
<p>6. <strong>Characteristic: </strong>are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures; <strong>Defined as: </strong>Defined by CodeableConcept matching value of are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures</p>
<p>7. <strong>Characteristic: </strong>are able and willing to give signed informed consent; <strong>Defined as: </strong>Defined by CodeableConcept matching value of are able and willing to give signed informed consent</p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>Patients will be excluded from study enrollment if they meet any of the following criteria at screening and/or enrollment: </p>
<p>
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 </p>
<p>
2. are Lilly employees </p>
<p>
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 </p>
<p>
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 </p>
<p>
5. have previously completed or withdrawn from this study or any other study investigating LY900018, and have previously received LY900018 </p>
<p>
6. have known allergies or sensitivity to LY900018, glucagon, related compounds, or any components of the formulation, or history of significant atopy </p>
<p>
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
</p>
<p>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 </p>
<p>
9. have received a total daily dose of insulin >1.2 U/kg at the time of screening </p>
<p>
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 </p>
<p>
11. have a history of pheochromocytoma (ie, adrenal gland tumor) or insulinoma </p>
<p>
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 </p>
<p>
13. have a history of epilepsy or seizure disorder </p>
<p>
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 </p>
<p>
15. have known or ongoing psychiatric disorders that, in the opinion of the investigator, may preclude the patient from following and completing the protocol </p>
<p>
16. regularly use known drugs of abuse and/or show positive findings on urinary drug screening </p>
<p>
17. show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies and/or antigen </p>
<p>
18. show evidence of hepatitis C and/or positive hepatitis C antibody
</p>
<p>19. show evidence of hepatitis B and/or positive hepatitis B surface antigen </p>
<p>
20. show evidence of syphilis and/or are positive for syphilis test </p>
<p>
21. are women who are lactating </p>
<p>
22. use of daily systemic beta-blocker, indomethacin, warfarin, anticholinergic drugs </p>
<p>
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
</p>
<p>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) </p>
<p>
25. in the opinion of the investigator or sponsor, are unsuitable for inclusion in the study</p>
<p>
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.</p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>Male patients must use an effective method of contraception for the duration of the study and for 28 days following the last study treatment. Female patients of childbearing potential must use one highly effective method of contraception (<1% failure rate; such as combined oral contraceptive pill, implanted contraceptives, or intrauterine device) or a combination of 2 effective methods of contraception (such as male or female condoms with spermicide [not approved in Japan], diaphragms with spermicide [not approved in Japan], or cervical sponges) during the study and for 28 days following the last study treatment. 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.</p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>In both treatment periods, patients will fast for at least 8 hours prior to beginning the hypoglycemia induction procedure. Patients should not be given any calorie-containing food/drink during insulin-induced hypoglycemia and within 90 minutes of glucagon administration unless there is a safety concern. The patients will receive a carbohydrate-rich meal after completion of all pharmacokinetic (PK) blood sample collections, at 240 minutes post glucagon dose. Patients will be given access to calorie-free water up to 240 minutes post study treatment. While resident in the CRU, patients should not consume any food or caloric drinks other than that provided by the CRU. When not resident in the CRU, patients will be encouraged to follow their normal diets</p></div>
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<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>Patients are encouraged to maintain their regular exercise habits for the duration of the study. However, patients should avoid strenuous exercise 48 hours prior to admission or study visit. From the beginning of hypoglycemia induction to 240 minutes post study treatment, patients should remain recumbent or sitting on the bed.</p></div>
</text>
</section>
<section>
<title value="Other Activity Restrictions"/>
<code>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C218558"/>
<display
value="ICH M11 Protocol Section 5.5.4 Other Activity Restrictions"/>
</coding>
<text value="section5.5.4-other-restrictions"/>
</code>
<text>
<status value="empty"/>
<div xmlns="http://www.w3.org/1999/xhtml">[If applicable, describe restrictions on any other activity (for example, blood or tissue donation, driving, heavy machinery use, or sun exposure).]</div>
</text>
</section>
</section>
<section>
<title value="Screen Failure and Rescreening"/>
<code>
<coding>
<system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C218559"/>
<display
value="ICH M11 Protocol Section 5.6 Screen Failure and Rescreening"/>
</coding>
<text value="section5.6-screen-failure"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>Individuals who do not meet the criteria for participation in this study (screen failure) may not be re-screened.</p></div>
</text>
</section>
</section>
</Composition>
IG © 2024+ HL7 International / Clinical Decision Support.
Package hl7.fhir.uv.ebm#1.0.0-ballot3 based on FHIR 6.0.0-ballot3.
Generated
2026-06-02
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