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within category "Diabetes & Hormones"
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Feasibility and Effectiveness of Real-time, Remote Continuous Glucose Monitoring in Adolescents With Poorly Controlled Type 1 Diabetes
Adolescents with Type 1 Diabetes (age 13-18 years, T1D duration >6 months managed on insulin)
and poor glycemic control will wear a blinded CGM to obtain baseline data. After assuring
adherence to CGM wear, participants will receive a non-blinded CGM and will share their blood
glucose levels with the study team. Clinical personnel will remotely monitor patients in
real-time for 3 months and communicate regularly over secure text messaging with participants
and their parents. Following active remote monitoring, the participants will wear a
non-blinded CGM for 3 months. Primary outcome assessment will be the change in HbA1c after 3
months of real-time remote continuous glucose monitoring.
• Age between 13-18
• Diagnosis of type 1 diabetes for at least six months.
• Both sexes and all ethnicities included.
• Subject and at least one parent able to communicate in English.
• Poorly controlled T1D as evidenced by a >40% annual risk of developing DKA in the
following year
• Treated with subcutaneous insulin, either with a basal/bolus insulin regimen or a
continuous subcutaneous insulin infusion (CSII) device.
• Willing to wear CGM and utilize the share function to clinician and guardian, with
measuring blood glucose checks as required by the CGM.
• Owning a smartphone compatible with Dexcom G6 software to allow the use of
share/follow features with internet access capabilities
• Willing to participate in secure text messaging with study personnel.
• Female participants must have a negative pregnancy test.
Exclusion Criteria:
• Type 2 diabetes, secondary diabetes or CF related diabetes.
• Other severe chronic disease (e.g., cancer) which in the judgment of the investigator
is likely to significantly affect glycemic control.
• Patients cannot be taking systemic corticosteroids at enrollment because of adverse
effects on glycemic control, but we will not disqualify subjects who require such
therapy during the study. Inhaled or topical corticosteroids are permissible.
• Patients with hypothyroidism or hyperthyroidism must be clinically euthyroid and have
free T4 and TSH within age-appropriate reference ranges at last medically indicated
testing. Patients with out of range values may be retested after medication dose
adjustment.
• Developmental delay or behavioral disorder in the patient of sufficient severity, in
the judgment of the investigator, to interfere with study activities. Severe
uncontrolled depression defined as PHQ-9A >9 at time of enrollment is an exclusion
criterion.
• Medical or psychiatric disorder in a parent of sufficient severity, in the judgment of
the investigator, to interfere with study activities.
• Regular CGM for the month preceding study period.
• Pregnancy, planned pregnancy or breast feeding
• CGM adhesive allergy
• Skin condition that makes CGM placement contraindicated.
• Sickle cell disease or hemoglobinopathy
• Red blood cell transfusion within 3 months prior to study enrollment
Hydroxychloroquine in Individuals At-risk for Type 1 Diabetes Mellitus (TN-22)
The study is a 2-arm, double blinded, multicenter, 2:1 randomized, placebo controlled
clinical trial. Subjects will receive hydroxychloroquine or placebo and close monitoring for
progression of T1D.
1. Participant in TrialNet Pathway to Prevention Study (TN01)
2. Age 3 years or greater at the time of randomization
3. Willing to provide informed consent
4. Normal glucose tolerance by OGTT within 7 weeks (no more than 52 days) of baseline
5. Two or more diabetes-related autoantibodies present on two separate samples
6. Weight of 12 kg or greater at screening
7. If a female participant with reproductive potential, willing to avoid pregnancy and
undergo pregnancy testing prior to randomization and at each study visit
8. Anticipated ability to swallow study medication.
Exclusion Criteria:
1. Abnormal Glucose Tolerance or Diabetes
2. History of treatment with insulin or other diabetes therapies
3. Ongoing use of medications known to influence glucose tolerance
4. Ongoing or anticipated future use of medications known to have untoward interactions
with hydroxychloroquine
5. Known hypersensitivity to 4-aminoquinoline compounds
6. G6PD deficiency
7. History of retinopathy
8. Have an active infection at time of randomization
9. Have serologic evidence of current or past HIV, Hepatitis B (positive for Hepatitis B
core antibody or surface antigen), or Hepatitis C infection
10. Deemed unlikely or unable to comply with the protocol or have any complicating medical
issues, including prolonged QT interval, a disease previously or likely in the future
to require immunosuppression, or abnormal clinical laboratory results that interfere
with study conduct or cause increased risk.
A 12 Month Site Randomized Trial in Adults With Type 2 Diabetes Mellitus and History of Cardiovascular Disease (COORDINATE)
COORDINATE-Diabetes is a cluster-randomized clinical trial to test the effectiveness of an
innovative, clinic-level educational intervention to improve the management of patients with
type 2 diabetes mellitus and cardiovascular disease.
• Age ≥ 18 years old
• Diagnosis of Type 2 diabetes mellitus (T2DM)
• History of at least one of the following conditions:
1. Coronary artery disease (defined as prior MI, coronary revascularization (CABG or
PCI), and/or obstructive CAD (≥50%) as documented by angiography or CTA)
2. Stroke and/or carotid artery stenosis (≥50%)
3. Peripheral Arterial disease (defined as claudication with ABI<0.9, prior
peripheral revascularization, and/or amputation due to circulatory insufficiency)
• Ability to communicate with site staff and understand and provide written informed
consent and proof of Health Insurance Portability and Accountability Act (HIPAA)
authorization
Exclusion Criteria:
• Determined to be highly unlikely to survive and/or to continue follow-up in that
clinic for at least 1 year, as identified by site investigator
• GFR<30 mL/min/1.73m2
• Already on all guideline-recommended therapies for T2DM and CVD
• Absolute contraindication to any of the guideline recommended therapies for T2DM and
CVD
Other: Intense Education Intervention
Diabetes Mellitus, Type 2, Cardiovascular Diseases
COORDINATE-DIABETES, COORDINATE, T2DM, Diabetes Mellitus, Type 2, Cardiovascular Disease, Prevention
UT Southwestern; Parkland Health & Hospital System
A Research Study to See How Well the New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Level in People With Type 2 Diabetes Compared to Weekly Insulin Icodec (COMBINE 1)
This study will compare the new medicine IcoSema, which is a combination of insulin icodec
and semaglutide, taken once a week, to insulin icodec taken once a week in people with type 2
diabetes.
The study will look at how well IcoSema controls blood sugar level in people with type 2
diabetes compared to insulin icodec.
Participants will either get IcoSema or insulin icodec. Which treatment participants get is
decided by chance. IcoSema and insulin icodec are both new medicines that doctors cannot
prescribe.
Participants will get IcoSema or insulin icodec, which participants must inject once a week
with a pen, which has a small needle, in a skin fold in the thigh, upper arm, or stomach.
The study will last for about 1 year and 1 month. Participants will have 21 clinic visits, 31
phone/video calls with the study doctor, and 4 contacts with the site that can either be
clinic visits or phone/video calls At 11 clinic visits participants will have blood samples
taken. At 7 clinic visits participants cannot eat or drink (except for water) for 8 hours
before the visit.
Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study
period.
Not applicable for China: Participants will be asked to wear a sensor that measures their
blood sugar level all the time during a 5 week period at the end of the study.
Key inclusion criteria
1. Male or female and age above or equal to 18 years at the time of signing informed
consent.
2. Diagnosed with type 2 diabetes mellitus 180 days or more before screening.
3. HbA1c of 7.0 10.0% (53.0 85.8 mmol/mol) (both inclusive) as assessed by central
laboratory on the day of screening.
4. Treated with once daily or twice daily basal insulin (neutral protamine hagedorn
insulin, insulin degludec, insulin detemir, insulin glargine 100 units/mL, or insulin
glargine 300 units/mL) 20- 80 units/day for 90 days or more before screening. Short
term bolus insulin treatment for a maximum of 14 days before screening is allowed, as
is prior insulin treatment for gestational diabetes. The treatment can be with or
without any of the following anti diabetic drugs with stable doses for 90 days or more
before screening:
• Metformin
• Sulfonylureas (a)
• Meglitinides (glinides) (a)
• DPP 4 inhibitors (a)
• Sodium glucose co transporter 2 inhibitors
• Alpha glucosidase inhibitors
• Thiazolidinediones
• Marketed oral combination products only including the products listed above.
5. Body mass index (BMI) below or equal to 40.0 kg/m^2. (a) Sulfonylureas, meglitinides
(glinides) and DPP 4 inhibitors must be discontinued at randomisation.
Key exclusion criteria
1. Female who is pregnant, breast-feeding or intends to become pregnant or is of
childbearing potential and not using a highly effective contraceptive method.
2. Anticipated initiation or change in concomitant medication (for more than 14
consecutive days) known to affect weight or glucose metabolism (e.g. treatment with
orlistat, thyroid hormones, or systemic corticosteroids).
3. Treatment with any medication for the indication of diabetes or obesity other than
stated in the inclusion criteria within 90 days before screening.
4. Any episodes (as declared by the participant or in the medical records.) of diabetic
ketoacidosis within 90 days before screening.
5. Presence or history of pancreatitis (acute or chronic) within 180 days before
screening.
6. Any of the following: Myocardial infarction, stroke, hospitalization for unstable
angina pectoris or transient ischaemic attack within 180 days before screening.
7. Chronic heart failure classified as being in New York Heart Association Class IV at
screening.
8. Recurrent severe hypoglycaemic episodes within the last year (12 months) as judged by
the investigator.
9. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by
a fundus examination performed within the past 90 days before screening or in the
period between screening and randomisation. Pharmacological pupil dilation is a
requirement unless using a digital fundus photography camera specified for non-dilated
examination.
Multi-center Study to Assess Safety, Tolerability and Efficacy of Topical Pravibismane in Moderate/Severe DFI Patients
This is a randomized, open label, controlled, multi-center study to assess safety,
tolerability, and efficacy of adjunctive treatment with topically applied pravibismane
(MBN-101) in patients with moderate diabetic foot infections. Patients will be randomized in
a 2:1 ratio (MBN-101:standard of care). Topical pravibismane (MBN-101) will be applied three
times per week for up to 12 weeks. All patients will receive systemic antibiotic treatment
for a least a portion of that period. Randomization will be stratified by site.
• Has diabetes mellitus, according to the American Diabetes Association (ADA) criteria.
• Has an infection located on or distal to the malleolus that is ≥ 4 weeks old and where
the excision post-surgically measures 1.5-20 cm2 and presents with clinical
manifestations of a moderate infection.
• Has received no more than 36 hours of antibiotic therapy for the moderately infected
ulcer prior to enrollment or there is clinical and/or microbiological evidence of
failure of antibiotic treatment for the treatment of the moderately infected ulcer.
• Has documented adequate arterial perfusion in the affected limb by biphasic or
triphasic Doppler wave forms, a toe brachial index (TBI) ≥0.75, or an ankle brachial
index (ABI) of >0.9).
• Has read and signed the Informed Consent Form (ICF) after the nature of the study has
been fully explained.
Exclusion Criteria:
• Has proven or highly suspected, involvement of bone (i.e., osteomyelitis).
• Has an ulcer due to Charcot arthropathy.
• Has more than one concurrent, infected, diabetic foot wound on the study limb.
• Is unwilling or unable to attend clinic visits and keep research appointments.
• Is unwilling or unable to adhere to the systemic antibiotic treatment prescribed.
• Is unwilling or unable to adhere to proper pressure off-loading of the foot wound
(when needed) from enrollment through EOS as directed by the treating physician.
• Has an untreated, uncontrolled, or poorly managed immunosuppressive and or autoimmune
disorder.
• Plans to use any topical antibiotics, herbals remedies (e.g., honey), alternative
medicines or antimicrobials, either directly or by dressings on their infected DFU at
any time from enrollment through the EOS visit.
• Plans to receive treatment with larvae (maggots) for their infected DFU at any time
from enrollment through the EOS visit.
• Plans to receive treatment with advanced cellular therapies (e.g., Platelet-derived
growth factor (PDGF), Cellular Tissue Products (CTP), granulocyte colony-stimulating
factor (G CSF)) for their infected DFU at any time from enrollment through the EOS
visit.
• History of major medical noncompliance.
• Any condition that has required treatment with any other bismuth containing compound
within 2 weeks prior to enrollment through EOS visit (i.e., Kaopectate or
Pepto-Bismol, including topical applications such as Xeroform).
• Plans to receive treatment with Hyperbaric oxygen therapy (HBOT) or topical negative
pressure wound therapy (NPWT) for their infected DFU at any time from enrollment
through the EOS visit.
• Glycated hemoglobin >12%.
• Has a serum creatinine, ALT, AST or Alkaline Phosphatase >3 times the upper limit of
the normal range of the local testing laboratory.
• End stage renal disease requiring dialysis.
• Has an absolute neutrophil count <1000.
• Has participated in an investigational trial to evaluate pharmaceuticals or biologics
either concurrently or within the past 30 days.
• Will undergo a planned surgical therapy beyond standard bedside debridement or
incision and drainage, to treat the DFI after enrollment.
• Has a known allergy to bismuth and/or MBN-101 excipients (methylcellulose, Tween 80
(polysorbate 80)).
• Is immunocompromised and not well-managed due to illness [human immunodeficiency virus
(HIV), autoimmune disease] or organ transplant.
• Has a history of any type of cancer (excluding non-melanoma localized skin cancer or
completely excised and cured carcinoma-in-situ of uterine cervix) unless the subject
has been free of cancer for > 5 years.
• Developmental disability/significant psychological disorder that in the opinion of the
investigator could impair the subject's ability to provide informed consent,
participate in the study protocol or record study measures.
• Active alcohol abuse (> 14 drinks per week over the last 3 months) or substance abuse
(current use of cocaine, heroin, or methamphetamines) or if drug or alcohol use will
interfere with visits in clinic in the opinion of the investigator.
• Has other medical condition(s) which, in the opinion of the Principal Investigator,
would jeopardize the safety of the study subject or impact the validity of the study
results.
Drug: Topical Pravibismane, Other: Standard of Care
A Study of CIN-107 in Adults With Primary Aldosteronism
This is a multicenter, open-label study in adult patients with PA to evaluate the
effectiveness and safety of CIN-107 after up to 12 weeks of treatment, at doses from 2 to 8
mg per day, for the management of blood pressure in patients with primary aldosteronism (PA).
1. Have been diagnosed with PA.
2. Are taking mineralocorticoid receptor antagonist (MRA) to control BP; or are newly
diagnosed with PA and have not started MRA treatment.
3. Are willing and able to cease dosing of MRA for up to 4 weeks in patients taking MRA.
4. Are willing to be compliant with the contraception and reproduction restrictions of
the study.
5. Have increased SBP by ≥ 20 mmHg or have SBP ≥ 160 mmHg after dosing of MRA treatment
is ceased for up to 4 weeks duration, or have SBP ≥ 150 mmHg for patients who are
newly diagnosed with PA and have not taken an MRA in the past 12 weeks.
Exclusion Criteria:
1. At Screening Visit, have a single occurrence of mean seated SBP > 180 mmHg or DBP >
110 mmHg if not taking an MRA; or have a mean seated SBP ≥ 160 mmHg or DBP ≥ 100 mmHg
if currently taking an MRA.
2. Have a body mass index > 45 kg/m2.
3. Have had a previous surgical intervention for an adrenal adenoma or have a planned
adrenal carcinoma, adrenalectomy, renal nerve denervation, or adrenal ablative
procedure during the course of the study.
4. Have a documented estimated glomerular filtration rate < 45 mL/min/1.73 m2.
5. Have a planned dialysis, kidney transplantation or any major surgical procedure during
the course of the study.
6. Have known documented New York Heart Association class III or IV chronic heart
failure.
7. Have had a stroke, transient ischemic attack, hypertensive encephalopathy, acute
coronary syndrome, or hospitalization for heart failure within 6 months before the
Screening Visit.
8. Have known current severe left ventricular outflow obstruction.
9. Have had major cardiac surgery within 6 months before the Screening Visit.
10. Have a history of, or currently experiencing, clinically significant arrhythmias.
11. Have had a prior solid organ transplant or cell transplant.
12. Are positive for HIV antibody, hepatitis C virus RNA, or hepatitis B surface antigen.
13. Have typical consumption of > 14 alcoholic drinks weekly.
RATIONALE
The accrual of data from the laboratory and from epidemiologic and prevention trials has
improved the understanding of the etiology and pathogenesis of type 1 diabetes mellitus
(T1DM). Genetic and immunologic factors play a key role in the development of T1DM, and
characterization of the early metabolic abnormalities in T1DM is steadily increasing.
However, information regarding the natural history of T1DM remains incomplete. The TrialNet
Natural History Study of the Development of T1DM (Pathway to Prevention Study) has been
designed to clarify this picture, and in so doing, will contribute to the development and
implementation of studies aimed at prevention of and early treatment in T1DM.
Purpose:
TrialNet is an international network dedicated to the study, prevention, and early treatment
of type 1 diabetes. TrialNet sites are located throughout the United States, Canada,
Finland, United Kingdom, Italy, Germany, Sweden, Australia, and New Zealand. TrialNet is
dedicated to testing new approaches to the prevention of and early intervention for type 1
diabetes.
The goal of the TrialNet Natural History Study of the Development of Type 1 Diabetes is to
enhance our understanding of the demographic, immunologic, and metabolic characteristics of
individuals at risk for developing type 1 diabetes.
The Natural History Study will screen relatives of people with type 1 diabetes to identify
those at risk for developing the disease. Relatives of people with type 1 diabetes have
about a 5% percent chance of being positive for the antibodies associated with diabetes.
TrialNet will identify adults and children at risk for developing diabetes by testing for
the presence of these antibodies in the blood. A positive antibody test is an early
indication that damage to insulin-secreting cells may have begun. If this test is positive,
additional testing will be offered to determine the likelihood that a person may develop
diabetes. Individuals with antibodies will be offered the opportunity for further testing to
determine their risk of developing diabetes over the next 5 years and to receive close
monitoring for the development of diabetes.
• Individuals 1 to 45 years old who have an immediate family member with type 1
diabetes (such as a child, parent, or sibling)
• Individuals 1-20 years old who have an extended family member with type 1 diabetes
(such as a cousin, niece, nephew, aunt, uncle, grandparent, or half-sibling)
Exclusion Criteria:
To be eligible a person must not:
• Have diabetes already
• Have a previous history of being treated with insulin or oral diabetes medications.
• Currently be using systemic immunosuppressive agents (topical and inhaled agents are
acceptable)
• Have any known serious diseases
Diabetes Mellitus, Type 1, Pancreas
"at risk" for developing type 1 diabetes, T1DM, T1D, juvenile diabetes, Type 1 Diabetes TrialNet, TrialNet
UT Southwestern; Children’s Health; Parkland Health & Hospital System
This is a prospective, non-randomized, non-blinded observational study. The overarching goal
is to discover new disease-associated genes in children, while establishing a specific focus
on disorders where molecular characterization is most likely to lead to novel therapies. This
study will merge detailed phenotypic characterization of patients presenting to the Pediatric
Genetics and Metabolism Division in the Department of Pediatrics/Children's Medical Center at
Dallas and collaborating clinics with Next-Generation sequencing techniques to identify
disease-producing mutations. The primary objective of the study is to identify novel
pathogenic mutations in children with rare Mendelian disorders. A secondary objective of the
study is to establish normative ranges of a large number of metabolites from healthy newborns
and older children.
Inclusion criteria of Cohort 1- Newborn:
• Subjects aged 1-2 days
• Subjects with gestational age 37-42 weeks
• Subjects with stable clinical status (admitted to normal newborn nursery)
Inclusion criteria of Cohort 2 •Older children:
• Subjects aged 0-18 years
Inclusion criteria of Cohort 3 •Diseased children:
Subjects (no age limit) with ANY phenotype as below:
• Confirmed metabolic or genetic diseases
• Suspected metabolic or genetic diseases
• Episodic metabolic decompensation (e.g. hypoglycemia, hyperammonemia, metabolic
acidosis)
• Developmental regression
• Major congenital malformation
• Other unexplained symptoms of potential genetic origin
Exclusion criteria of Cohort 1 •Newborn:
• Subjects with gestational age <37 weeks or >42 weeks
• Subjects with overt signs of metabolic dysfunction, distress or genetic diseases
including hypoglycemia, hyperglycemia, sepsis/shock, hypoxemia, or major congenital
malformation
• Subjects with mothers whose pregnancies were complicated by gestational diabetes,
gestational hyperglycemia, gestational hypertension, preeclampsia, or any other major
disorders.
Exclusion criteria of Cohort 2 •Older children:
• Subjects with confirmed metabolic or genetic diseases
• Subjects with suspected metabolic or genetic diseases
• Subjects with episodic metabolic decompensation (e.g. hypoglycemia, hyperammonemia,
metabolic acidosis)
• Subjects with developmental regression
• Subjects with major congenital malformation
Exclusion criteria of Cohort 3 •Diseased children No.
Procedure: Skin Biopsy
Genetic Diseases, Metabolic Diseases, Other
Metabolism, Genetics, Metabolomics, Genomics
UT Southwestern; Children’s Health; Parkland Health & Hospital System
1. Adolescents and adults with previously documented diagnosis of Glut1 Deficiency with
diagnosis genetically confirmed or confirmed by PET scan of the brain.
2. Ages 16 to 65
3. Persons with dental fillings, dental crowns, and short (max.4 cm) dental retainer
wires can be included.
Exclusion Criteria:
1. People or patients with uncontrolled seizure disorder, defined as grand mal (not
absence) seizure in the preceding 3 months.
2. Pregnant females will be excluded. A serum or urine pregnancy test will be
administered to all females of child bearing potential within 24 hours of
administration of the tracer and MRI scan. The pregnancy test will be communicated in
person by the study PI. Positive results in subjects 17 years old or younger will be
disclosed to parent/guardian only.
3. Subjects with typical implanted orthopedic metal in bone may be considered for
inclusion in a 7T scan providing the implant is not within the volume of the radio
frequency coil. The PI and the AIRC Medical Director will discuss each case and
determine eligibility.
4. Persons with ICD, pacemakers, neurostimulators and other such devices will be
excluded.
5. Persons with claustrophobia are excluded.
6. Persons with questionable ferrous implants, bullets, BB's, and shrapnel will be
excluded.
7. Subjects who are not fluent in English will be excluded because immediate cooperation
and the ability to respond to instructions from the investigators are necessary.
Device: Magnetic resonance imaging
Glucose Transporter Type 1 Deficiency Syndrome, Epilepsy, Glut1 Deficiency Syndrome 1, Autosomal Recessive, Glucose Metabolism Disorders, Glucose Transport Defect, Glucose Transporter Protein Type 1 Deficiency Syndrome, Glut1 Deficiency Syndrome 1