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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"description" : "**Inclusion Criteria** \nPatients are eligible for inclusion in the study only if they meet all of the following criteria at screening and/or enrollment: \n1.\tMeet either T1DM-specific eligibility criteria or T2DM-specific eligibility criteria\n.a.\tT1DM-specific criteria\n..i.\tDiagnosis of T1DM based on the World Health Organization (WHO) diagnostic criteria\n..ii.\thave been on the following daily insulin therapy for at least 1 year \n...1)\tmultiple 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 \n...2)\tcontinuous subcutaneous insulin infusion (CSII) \n..iii.\tare between 18 and 64 years old at the time of informed consent\n..iv.\thave a body mass index of 18.5 to 30.0 kg/m2 at the time of screening \n.b.\tT2DM-specific criteria\n..i.\tDiagnosis of T2DM based on the World Health Organization (WHO) diagnostic criteria\n..ii.\thave received the following daily insulin therapy with or without oral anti-hyperglycemic medications (OAMs) for at least 1 year \n...1)\tinsulin: 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 \n...2)\tOAM: 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 \n..iii.\tare between 20 and 70 years old at the time of informed consent \n..iv.\thave a body mass index of 18.5 to 35.0 kg/m2 at the time of screening \n2.\thave a hemoglobin A1c value ≤10% at the time of screening \n3.\tagree to use an effective method of contraception, defined by study protocol\n4.\thave 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 \n5.\thave venous access sufficient to allow for blood sampling and administration of insulin for IV administration as per the protocol \n6.\tare reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures \n7.\tare able and willing to give signed informed consent.\n\n**Exclusion Criteria** \nPatients will be excluded from study enrollment if they meet any of the following criteria at screening and/or enrollment: \n1.\tare 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 \n2.\tare Lilly employees \n3.\tare 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 \n4.\thave 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 \n5.\thave previously completed or withdrawn from this study or any other study investigating LY900018, and have previously received LY900018 \n6.\thave known allergies or sensitivity to LY900018, glucagon, related compounds, or any components of the formulation, or history of significant atopy \n7.\thave an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risks associated with participating in the study\n8.\tany significant changes in insulin regimen and/or unstable blood glucose control within the past 3 months prior to screening as assessed by the investigator \n9.\thave received a total daily dose of insulin >1.2 U/kg at the time of screening \n10.\thave 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 \n11.\thave a history of pheochromocytoma (ie, adrenal gland tumor) or insulinoma \n12.\thave 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 \n13.\thave a history of epilepsy or seizure disorder \n14.\thave 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 \n15.\thave known or ongoing psychiatric disorders that, in the opinion of the investigator, may preclude the patient from following and completing the protocol \n16.\tregularly use known drugs of abuse and/or show positive findings on urinary drug screening \n17.\tshow evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies and/or antigen \n18.\tshow evidence of hepatitis C and/or positive hepatitis C antibody\n19.\t show evidence of hepatitis B and/or positive hepatitis B surface antigen \n20.\tshow evidence of syphilis and/or are positive for syphilis test \n21.\tare women who are lactating \n22.\tuse of daily systemic beta-blocker, indomethacin, warfarin, anticholinergic drugs \n23.\thave 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\n24.\thave 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) \n25.\tin the opinion of the investigator or sponsor, are unsuitable for inclusion in the study \n26.\thave 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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"description" : "Agree to not reproduce:\n. 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 \n. for female patients:\n.. 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.\n.. 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.\n... 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.\n... 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.\n.. c. women not of childbearing potential may participate, and include those who are:\n... i. infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation), congenital anomaly such as mullerian agenesis Or\n... ii. postmenopausal, defined as either:\n.... 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\n.... 2. a woman 55 or older not on hormone therapy, who has had at least 6 months of spontaneous amenorrhea, or\n.... 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" : true,
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"text" : "have previously completed or withdrawn from this study or any other study investigating LY900018, and have previously received LY900018"
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"exclude" : true,
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]
}
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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