The patient does not meet several key exclusion criteria, including BMI > 32 kg/m2, HbA1c > 9.5%, and use of metformin within the past three months. These factors make the patient ineligible for the trial.
Age: Females 18-50 years; males 21-50 years (minimum age based on skeletal maturity)
The patient is a 48-year-old male, which fits the age criteria for males (21-50 years).
References:
Diagnosis of type 1 diabetes (T1D) based on ADA Criteria:. Hyperglycemia (glycosylated hemoglobin (HbA1c) ≥ 6.5%; OR. fasting plasma glucose ≥ 126 mg/dl (7.0 mmol/L); OR. 2-hour plasma glucose ≥ 200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test; OR. In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose ≥ 200 mg/dl (11.1 mmol/L)
The patient has a diagnosis of type 1 diabetes mellitus, confirmed by both the FHIR bundle and patient note. However, the HbA1c level is 9.8%, which is above the inclusion threshold of 6.5%.
References:
Documented history of at least one type 1 diabetes associated autoantibody. GAD specific autoantibodies (GADA);. Islet-antigen 2 specific autoantibody (IA-2A); and/or. Zinc Transporter 8 specific autoantibody (ZNT8A)
There is no information available regarding the presence of type 1 diabetes-associated autoantibodies.
Time from T1D diagnosis to screening MMTT must be ≥ 12 months but ≤ 5 years
There is no information available regarding the time from T1D diagnosis to screening MMTT.
Non-fasting C-peptide concentrations of at least 0.2 nmol/L (0.6 ng/ml) at pre-screening and confirmed during a MMTT done at screening visit.
There is no information available regarding non-fasting C-peptide concentrations.
Serum calcium (corrected for albumin) within normal limits per site's local lab
There is no information available regarding serum calcium levels.
Agreement by women of childbearing potential (WOCBP) and males of childbearing potential to use a highly effective method of birth control for the course of the study through at least 5 months from the last dose of protocol therapy
The patient is male, and there is no information on the use of birth control methods.
History of delayed puberty unless there is radiologic evidence of skeletal maturity
There is no information available regarding a history of delayed puberty.
Use of other investigational agents within 3 months of enrollment
The patient has been taking metformin for the past three months, which is an investigational agent.
References:
Vitamin D3 deficiency (< 30 ng/ml)
There is no information available regarding Vitamin D3 levels.
History of anorexia and/or eating disorder
There is no information available regarding a history of anorexia or eating disorders.
BMI > 32 kg/m2
The patient has a BMI of 33 kg/m2, which exceeds the exclusion threshold of 32 kg/m2.
References:
HbA1c > 9.5%
The patient's HbA1c level is 9.8%, which exceeds the exclusion threshold of 9.5%.
References:
Severe hypoglycemia or diabetic ketoacidosis (DKA) within 3 months prior to screening. Subjects who had such episodes within 3-6 months prior to screening, must have written clearance from their treating physician.
The patient denies any recent episodes of severe hypoglycemia or diabetic ketoacidosis.
References:
Use of any of the diabetes medications other than insulin within 3 months of enrollment (e.g., metformin, sulfonylurea, GLP-1 agonists, DPP4 inhibitors, Symlin, SGLT2-inhibitors, amylin)
The patient has been taking metformin, a diabetes medication other than insulin, within the past three months.
References:
Treatment with any of the following drugs in past year: immunosuppressants, anticonvulsant therapy, adrenal or anabolic steroids, calcitonin, selective estrogen receptor modulator, sodium fluoride (other than dental treatment), teriparatide, abaloparatide, strontium or aromatase inhibitors; any history of bisphosphonate treatment.
There is no information available regarding treatment with the specified drugs in the past year.
Bone fractures (excluding skull, facial bones, metacarpals, fingers, toes and spontaneous fractures associated with severe trauma) within the past 12 months
There is no information available regarding bone fractures in the past 12 months.
Disorders associated with altered skeletal structure or function (Paget's disease, chronic liver disease (liver enzymes > twice the upper limit of normal), malignancy, hypoparathyroidism or hyperparathyroidism, acromegaly, Cushing's syndrome, hypopituitarism, chronic obstructive pulmonary disease, alcohol intake > 3 units/day)
There is no information available regarding disorders associated with altered skeletal structure or function.
Significant dental/oral disease, including prior history or current evidence of osteonecrosis/osteomyelitis of the jaw, active dental or jaw condition requiring oral surgery, non-healed dental/oral surgery, or planned invasive dental procedures for the course of the study
There is no information available regarding significant dental/oral disease.
Pregnancy or actively breastfeeding (within 6 months prior to screening), or planning to become pregnant with 5 months after last dose of protocol therapy
The patient is male, so this criterion regarding pregnancy and breastfeeding is not applicable.
The patient does not meet the key inclusion criterion regarding the time from T1D diagnosis to screening (criterion 4).
Age: Females 18-50 years; males 21-50 years (minimum age based on skeletal maturity)
The patient is a 33-year-old female, which meets the age criterion for females (18-50 years).
References:
Diagnosis of type 1 diabetes (T1D) based on ADA Criteria:. Hyperglycemia (glycosylated hemoglobin (HbA1c) ≥ 6.5%; OR. fasting plasma glucose ≥ 126 mg/dl (7.0 mmol/L); OR. 2-hour plasma glucose ≥ 200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test; OR. In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose ≥ 200 mg/dl (11.1 mmol/L)
The patient has a history of type 1 diabetes diagnosed 13 years ago, and her HbA1c level is 7.8%, which confirms hyperglycemia. This meets the diagnosis criteria for T1D based on ADA criteria.
References:
Documented history of at least one type 1 diabetes associated autoantibody. GAD specific autoantibodies (GADA);. Islet-antigen 2 specific autoantibody (IA-2A); and/or. Zinc Transporter 8 specific autoantibody (ZNT8A)
There is no information provided about the presence of type 1 diabetes-associated autoantibodies, such as GADA, IA-2A, or ZNT8A.
Time from T1D diagnosis to screening MMTT must be ≥ 12 months but ≤ 5 years
The patient was diagnosed with T1D 13 years ago, which is outside the required range of 12 months to 5 years from diagnosis to screening.
References:
Non-fasting C-peptide concentrations of at least 0.2 nmol/L (0.6 ng/ml) at pre-screening and confirmed during a MMTT done at screening visit.
The patient's C-peptide level is 0.7 ng/mL, which is above the required minimum of 0.6 ng/mL.
References:
Serum calcium (corrected for albumin) within normal limits per site's local lab
There is no information provided about the patient's serum calcium levels.
Agreement by women of childbearing potential (WOCBP) and males of childbearing potential to use a highly effective method of birth control for the course of the study through at least 5 months from the last dose of protocol therapy
The patient is a woman of childbearing potential, but there is no information about her agreement to use birth control during the study.
History of delayed puberty unless there is radiologic evidence of skeletal maturity
There is no information provided about a history of delayed puberty.
Use of other investigational agents within 3 months of enrollment
There is no information provided about the use of investigational agents within 3 months of enrollment.
Vitamin D3 deficiency (< 30 ng/ml)
There is no information provided about the patient's Vitamin D3 levels.
History of anorexia and/or eating disorder
There is no information provided about a history of anorexia or eating disorders.
BMI > 32 kg/m2
The patient's BMI is 28 kg/m2, which is below the exclusion threshold of 32 kg/m2.
References:
HbA1c > 9.5%
The patient's HbA1c level is 7.8%, which is below the exclusion threshold of 9.5%.
References:
Severe hypoglycemia or diabetic ketoacidosis (DKA) within 3 months prior to screening. Subjects who had such episodes within 3-6 months prior to screening, must have written clearance from their treating physician.
The patient denies any recent episodes of severe hypoglycemia or diabetic ketoacidosis.
References:
Use of any of the diabetes medications other than insulin within 3 months of enrollment (e.g., metformin, sulfonylurea, GLP-1 agonists, DPP4 inhibitors, Symlin, SGLT2-inhibitors, amylin)
The patient is managing her condition with insulin therapy, and there is no mention of other diabetes medications.
References:
Treatment with any of the following drugs in past year: immunosuppressants, anticonvulsant therapy, adrenal or anabolic steroids, calcitonin, selective estrogen receptor modulator, sodium fluoride (other than dental treatment), teriparatide, abaloparatide, strontium or aromatase inhibitors; any history of bisphosphonate treatment.
There is no information provided about the use of the specified drugs in the past year.
Bone fractures (excluding skull, facial bones, metacarpals, fingers, toes and spontaneous fractures associated with severe trauma) within the past 12 months
There is no information provided about bone fractures in the past 12 months.
Disorders associated with altered skeletal structure or function (Paget's disease, chronic liver disease (liver enzymes > twice the upper limit of normal), malignancy, hypoparathyroidism or hyperparathyroidism, acromegaly, Cushing's syndrome, hypopituitarism, chronic obstructive pulmonary disease, alcohol intake > 3 units/day)
There is no information provided about disorders associated with altered skeletal structure or function.
Significant dental/oral disease, including prior history or current evidence of osteonecrosis/osteomyelitis of the jaw, active dental or jaw condition requiring oral surgery, non-healed dental/oral surgery, or planned invasive dental procedures for the course of the study
There is no information provided about significant dental/oral disease.
Pregnancy or actively breastfeeding (within 6 months prior to screening), or planning to become pregnant with 5 months after last dose of protocol therapy
The patient is not pregnant or breastfeeding, and there is no mention of plans to become pregnant.
References:
The patient meets key inclusion criteria such as age, diagnosis of type 1 diabetes, and C-peptide levels. She does not meet any exclusion criteria based on the available information. Several criteria lack sufficient information, but they do not impact the overall eligibility.
Age: Females 18-50 years; males 21-50 years (minimum age based on skeletal maturity)
The patient is a 38-year-old female, which falls within the required age range of 18-50 years for females.
References:
Diagnosis of type 1 diabetes (T1D) based on ADA Criteria:. Hyperglycemia (glycosylated hemoglobin (HbA1c) ≥ 6.5%; OR. fasting plasma glucose ≥ 126 mg/dl (7.0 mmol/L); OR. 2-hour plasma glucose ≥ 200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test; OR. In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose ≥ 200 mg/dl (11.1 mmol/L)
The patient has a confirmed diagnosis of type 1 diabetes and an HbA1c of 8.7%, which meets the ADA criteria for hyperglycemia.
References:
Documented history of at least one type 1 diabetes associated autoantibody. GAD specific autoantibodies (GADA);. Islet-antigen 2 specific autoantibody (IA-2A); and/or. Zinc Transporter 8 specific autoantibody (ZNT8A)
There is no information provided about the presence of type 1 diabetes-associated autoantibodies.
Time from T1D diagnosis to screening MMTT must be ≥ 12 months but ≤ 5 years
The patient was diagnosed with type 1 diabetes approximately 3 years ago, which is within the required 12 months to 5 years range.
References:
Non-fasting C-peptide concentrations of at least 0.2 nmol/L (0.6 ng/ml) at pre-screening and confirmed during a MMTT done at screening visit.
The patient's C-peptide level is 0.3 nmol/L, which is above the required minimum of 0.2 nmol/L.
References:
Serum calcium (corrected for albumin) within normal limits per site's local lab
There is no information provided about the patient's serum calcium levels.
Agreement by women of childbearing potential (WOCBP) and males of childbearing potential to use a highly effective method of birth control for the course of the study through at least 5 months from the last dose of protocol therapy
The patient is a woman of childbearing potential, but there is no information about her agreement to use birth control.
History of delayed puberty unless there is radiologic evidence of skeletal maturity
There is no information provided about a history of delayed puberty.
Use of other investigational agents within 3 months of enrollment
The patient has not used any investigational agents within the past 3 months.
References:
Vitamin D3 deficiency (< 30 ng/ml)
There is no information provided about the patient's vitamin D3 levels.
History of anorexia and/or eating disorder
There is no information provided about a history of anorexia or eating disorders.
BMI > 32 kg/m2
The patient's BMI is 29 kg/m2, which is below the exclusion threshold of 32 kg/m2.
References:
HbA1c > 9.5%
The patient's HbA1c is 8.7%, which is below the exclusion threshold of 9.5%.
References:
Severe hypoglycemia or diabetic ketoacidosis (DKA) within 3 months prior to screening. Subjects who had such episodes within 3-6 months prior to screening, must have written clearance from their treating physician.
The patient denies any recent episodes of severe hypoglycemia or diabetic ketoacidosis.
References:
Use of any of the diabetes medications other than insulin within 3 months of enrollment (e.g., metformin, sulfonylurea, GLP-1 agonists, DPP4 inhibitors, Symlin, SGLT2-inhibitors, amylin)
The patient is only taking insulin and has not used any other diabetes medications in the past three months.
References:
Treatment with any of the following drugs in past year: immunosuppressants, anticonvulsant therapy, adrenal or anabolic steroids, calcitonin, selective estrogen receptor modulator, sodium fluoride (other than dental treatment), teriparatide, abaloparatide, strontium or aromatase inhibitors; any history of bisphosphonate treatment.
There is no information provided about the use of the specified drugs in the past year.
Bone fractures (excluding skull, facial bones, metacarpals, fingers, toes and spontaneous fractures associated with severe trauma) within the past 12 months
There is no information provided about bone fractures in the past 12 months.
Disorders associated with altered skeletal structure or function (Paget's disease, chronic liver disease (liver enzymes > twice the upper limit of normal), malignancy, hypoparathyroidism or hyperparathyroidism, acromegaly, Cushing's syndrome, hypopituitarism, chronic obstructive pulmonary disease, alcohol intake > 3 units/day)
There is no information provided about disorders associated with altered skeletal structure or function.
Significant dental/oral disease, including prior history or current evidence of osteonecrosis/osteomyelitis of the jaw, active dental or jaw condition requiring oral surgery, non-healed dental/oral surgery, or planned invasive dental procedures for the course of the study
There is no information provided about significant dental/oral disease.
Pregnancy or actively breastfeeding (within 6 months prior to screening), or planning to become pregnant with 5 months after last dose of protocol therapy
The patient is not pregnant or breastfeeding, and there is no information about plans to become pregnant.
References:
The patient does not meet the inclusion criterion regarding the time from T1D diagnosis to screening (criterion 4), which is a key factor for eligibility. Other criteria have insufficient information, but this alone makes the patient not eligible.
Age: Females 18-50 years; males 21-50 years (minimum age based on skeletal maturity)
The patient is a 28-year-old male, which meets the age requirement for males (21-50 years).
References:
Diagnosis of type 1 diabetes (T1D) based on ADA Criteria:. Hyperglycemia (glycosylated hemoglobin (HbA1c) ≥ 6.5%; OR. fasting plasma glucose ≥ 126 mg/dl (7.0 mmol/L); OR. 2-hour plasma glucose ≥ 200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test; OR. In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose ≥ 200 mg/dl (11.1 mmol/L)
The patient has a history of type 1 diabetes and an HbA1c of 7.2%, which meets the ADA criteria for hyperglycemia (HbA1c ≥ 6.5%).
References:
Documented history of at least one type 1 diabetes associated autoantibody. GAD specific autoantibodies (GADA);. Islet-antigen 2 specific autoantibody (IA-2A); and/or. Zinc Transporter 8 specific autoantibody (ZNT8A)
There is no information provided about the presence of type 1 diabetes-associated autoantibodies.
Time from T1D diagnosis to screening MMTT must be ≥ 12 months but ≤ 5 years
The patient was diagnosed with type 1 diabetes approximately eight years ago, which exceeds the 5-year maximum since diagnosis.
References:
Non-fasting C-peptide concentrations of at least 0.2 nmol/L (0.6 ng/ml) at pre-screening and confirmed during a MMTT done at screening visit.
The patient has a C-peptide level of 0.7 ng/mL, which is above the required minimum of 0.6 ng/mL.
References:
Serum calcium (corrected for albumin) within normal limits per site's local lab
There is no information provided about the patient's serum calcium levels.
Agreement by women of childbearing potential (WOCBP) and males of childbearing potential to use a highly effective method of birth control for the course of the study through at least 5 months from the last dose of protocol therapy
The patient is male and married, but there is no information about the use of birth control.
History of delayed puberty unless there is radiologic evidence of skeletal maturity
There is no information provided about a history of delayed puberty.
Use of other investigational agents within 3 months of enrollment
There is no information provided about the use of investigational agents within 3 months of enrollment.
Vitamin D3 deficiency (< 30 ng/ml)
There is no information provided about the patient's Vitamin D3 levels.
History of anorexia and/or eating disorder
There is no information provided about a history of anorexia or eating disorders.
BMI > 32 kg/m2
The patient has a BMI of 24 kg/m2, which is below the exclusion threshold of 32 kg/m2.
References:
HbA1c > 9.5%
The patient's HbA1c is 7.2%, which is below the exclusion threshold of 9.5%.
References:
Severe hypoglycemia or diabetic ketoacidosis (DKA) within 3 months prior to screening. Subjects who had such episodes within 3-6 months prior to screening, must have written clearance from their treating physician.
The patient denies any recent episodes of severe hypoglycemia or diabetic ketoacidosis.
References:
Use of any of the diabetes medications other than insulin within 3 months of enrollment (e.g., metformin, sulfonylurea, GLP-1 agonists, DPP4 inhibitors, Symlin, SGLT2-inhibitors, amylin)
The patient has not used any diabetes medications other than insulin in the past three months.
References:
Treatment with any of the following drugs in past year: immunosuppressants, anticonvulsant therapy, adrenal or anabolic steroids, calcitonin, selective estrogen receptor modulator, sodium fluoride (other than dental treatment), teriparatide, abaloparatide, strontium or aromatase inhibitors; any history of bisphosphonate treatment.
There is no information provided about the use of the specified drugs in the past year.
Bone fractures (excluding skull, facial bones, metacarpals, fingers, toes and spontaneous fractures associated with severe trauma) within the past 12 months
There is no information provided about bone fractures in the past 12 months.
Disorders associated with altered skeletal structure or function (Paget's disease, chronic liver disease (liver enzymes > twice the upper limit of normal), malignancy, hypoparathyroidism or hyperparathyroidism, acromegaly, Cushing's syndrome, hypopituitarism, chronic obstructive pulmonary disease, alcohol intake > 3 units/day)
There is no information provided about disorders associated with altered skeletal structure or function.
Significant dental/oral disease, including prior history or current evidence of osteonecrosis/osteomyelitis of the jaw, active dental or jaw condition requiring oral surgery, non-healed dental/oral surgery, or planned invasive dental procedures for the course of the study
There is no information provided about significant dental/oral disease.
Pregnancy or actively breastfeeding (within 6 months prior to screening), or planning to become pregnant with 5 months after last dose of protocol therapy
The patient is male, so this criterion about pregnancy and breastfeeding is not applicable.