This group will continue to receive standard care for ACTH monitoring and follow-up with includes blood pressure and blood glucose monitoring by the patient's PCP while on therapy, a one week nursing follow-up phone call, and a two-week EEG and Neurology appointment.

This group will be provided remote monitoring technology where they will be able to monitor blood pressure and blood glucose at home. In addition, they will receive a nurse-led telemedicine visit at one week and three weeks of therapy. Like the control group, they will still receive a two-week EEG and Neurology appointment.

Infantile Spasms, Non-Intractable

Caregivers will be able to monitor blood pressure and blood glucose from home and upload in a cloud-based application on a hand-held tablet. In addition, this technology will administer surveys to the caregiver to assess for therapy side effects and adherence. Nurse-led telemedicine visits will also be utilized. The healthcare team will be able to monitor these parameters remotely.

Remote monitoring

Children's Hospital Colorado

Decreasing Parental Stress of Caregivers of Infants With Infantile Spasms by Using Telemedicine Technology

Decreasing Parental Stress and Costs While Improving Overall Satisfaction of Caregivers of Infants With Infantile Spasms on ACTH Therapy Utilizing Innovative Telemedicine Technology: A Randomized Study

Parental stress will be measures by the Pediatric Inventory for Parents (PIP), a previously validated survey. The PIP is scored separately for each of the 4 domains (Communication, Emotional Distress, Medical Care, Role Function), across 2 scales: Frequency (F) and Difficulty (D). The range for each of the scales is 42-210, with a higher score on either scale indicating more stress.

Overall treatment satisfaction will be measured by the Treatment Satisfaction Questionnaire for Medications, version 9 (TSQM v9) survey. This is a previously validated survey. The scores for the TSQM v9 can range from 1-100, with a higher score indicating greater satisfaction.

Caregivers will be asked to provide details on both direct and indirect costs incurred during therapy. This will be measured by collecting both healthcare utilizations rates, actual out-of-pocket expenses, and lost productivity measures. Combined direct and indirect expenses will be combined and compared.

University of Colorado, Denver

Mallinckrodt

Patients with infantile spasms will be randomized into either the control group that will receive traditional follow-up or the intervention group that will receive remote monitoring for follow-up. Both groups will complete surveys to collect data on parental stress, direct and indirect costs, and overall satisfaction with therapy.

patients with growth hormone deficiency or hypothalamic-pituitary disorders underwent fixed-dose glucagon stimulation test (GST), weight-based GST and insulin tolerance test (ITT).

The control group will consist of healthy volunteers matched to the study group for age, gender, Body mass index (BMI) and estrogen status. Note: Allegheny site is not enrolling in the control group.
Control subjects underwent fixed-dose glucagon stimulation test (GST), weight-based GST and insulin tolerance test (ITT).

patients with growth hormone deficiency or hypothalamic-pituitary disorders
Glucagon stimulation test and insulin tolerance test: glucagon stimulation test using 1 mg (1.5 mg if weigh >90 kg) glucagon stimulation test using 0.03 mg/kg (maximum dose 3 mg) insulin tolerance test using 0.10-0.15 U/kg ACTH stimulation test in subjects with T2DM, CAD, CVD, seizure

Study Patients

The control group will consist of healthy volunteers matched to the study group for age, gender, BMI and estrogen status. Note: Allegheny site is not enrolling in the control group.
glucagon stimulation test and insulin tolerance test: glucagon stimulation test using 1 mg (1.5 mg if weigh >90 kg) glucagon stimulation test using 0.03 mg/kg (maximum dose 3 mg) insulin tolerance test using 0.10-0.15 U/kg ACTH stimulation test in subjects with T2DM, CAD, CVD, seizure

Control

Total

Sex: Female, Male

Region of Enrollment

The peak growth hormone (GH) during Insulin Tolerance Test (ITT), fixed- dose glucagon stimulation test (GST) and weight-based GST in patients with adult onset hypothalamic-pituitary disease and 1-2 pituitary hormone deficiency (PHD) other than growth hormone (GH) deficiency.

Patients with hypothalamic-pituitary disorders and 1-2 pituitary hormone deficiency (PHD) other than GH deficiency
insulin tolerance test using 0.10-0.15 U/kg ACTH stimulation test was used in 3 subjects who were not eligible for ITT

Patients With 1-2 PHD- Insulin Tolerance Test

Patients with hypothalamic-pituitary disorders and 1-2 pituitary hormone deficiency (PHD) other than GH deficiency

Patients With 1-2 PHD- Fixed Dose GST

Patients With 1-2 PHD- Weight Based GST

Peak GH Level in Adult Patients With Hypothalamic-pituitary Disorders and 1-2 Pituitary Hormone Deficiency (PHD).

The peak growth hormone (GH) during Insulin Tolerance Test (ITT), fixed- dose glucagon stimulation test (GST) and weight-based GST in healthy volunteers

The control group consist of healthy volunteers matched to the study group for age, gender, BMI and estrogen status. Note: Allegheny site did not enroll the control group. All underwent insulin tolerance test using 0.10-0.15 U/kg

Control Group- ITT

The control group consist of healthy volunteers matched to the study group for age, gender, BMI and estrogen status. Note: Allegheny site is not enrolling in the control group.

Control Group- Fixed-dose GST

Control Group- Weight-based GST

Peak Growth Hormone (GH) Level in Healthy Volunteers

The peak growth hormone (GH) during Insulin Tolerance Test (ITT), fixed- dose glucagon stimulation test (GST) and weight-based GST in patients with adult onset hypothalamic-pituitary disease with three or more pituitary hormone deficiency (PHD) other than growth hormone (GH) deficiency.

Patients with hypothalamic-pituitary disorders and three or more pituitary hormone deficiency (PHD) other than GH deficiency
insulin tolerance test using 0.10-0.15 U/kg ACTH stimulation test was used in 3 subjects who were not eligible for ITT

Patients With 3 or More PHD- Insulin Tolerance Test

Patients with hypothalamic-pituitary disorders and three or more pituitary hormone deficiency (PHD) other than GH deficiency

Patients With 3 or More PHD- Fixed Dose GST

Patients With 3 or More PHD- Weight Based GST

Peak GH Level in Adult Patients With Hypothalamic-pituitary Disorders and Three or More Pituitary Hormone Deficiency (PHD).

The peak cortisol level during Insulin Tolerance Test (ITT), fixed- dose glucagon stimulation test (GST) and weight-based GST in patients with adult onset hypothalamic-pituitary disease and 1-2 pituitary hormone deficiency (PHD) other than growth hormone (GH) deficiency.

Peak Cortisol Level in Adult Patients With Hypothalamic-pituitary Disorders and 1-2 Pituitary Hormone Deficiency (PHD).

The peak cortisol levels during Insulin Tolerance Test (ITT), fixed- dose glucagon stimulation test (GST) and weight-based GST in healthy volunteers.

Peak Cortisol Level in Healthy Volunteers.

The peak cortisol level during Insulin Tolerance Test (ITT), fixed- dose glucagon stimulation test (GST) and weight-based GST in patients with adult onset hypothalamic-pituitary disease and three or more pituitary hormone deficiency (PHD) other than growth hormone (GH) deficiency.

Peak Cortisol Level in Adult Patients With Hypothalamic-pituitary Disorders and Three or More Pituitary Hormone Deficiency (PHD).

The peak cortisol level during ACTH stimulation test in 3 patients with adult onset hypothalamic-pituitary disease who were older than 65 years of age and could not under go insulin tolerance test (ITT).

Three patients with adult onset hypothalamic-pituitary disease underwent who were older than 65 years of age underwent ACTH stimulation test instead of ITT.

Patients Older Than 65

Peak Cortisol Level During Adrenocorticotropin Hormone (ACTH) Stimulation Test

patients with growth hormone deficiency or hypothalamic-pituitary disorders
Glucagon stimulation test and insulin tolerance test: glucagon stimulation test using 1 mg (1.5 mg if weigh >90 kg) glucagon stimulation test using 0.03 mg/kg (maximum dose 3 mg) insulin tolerance test using 0.10-0.15 U/kg adrenocorticotropin hormone (ACTH) stimulation test in subjects with type 2 diabetes mellitus (T2DM), coronary artery disease (CAD), cerebrovascular disease (CVD), seizure

Overall Study

Dr. Amir H. Hamrahian

patients with hypothalamic-pituitary disorders
Glucagon stimulation test and insulin tolerance test: glucagon stimulation test using 1 mg (1.5 mg if weigh >90 kg) glucagon stimulation test using 0.03 mg/kg (maximum dose 3 mg) insulin tolerance test using 0.10-0.15 U/kg ACTH stimulation test in subjects with T2DM, CAD, CVD, seizure

Adult Growth Hormone Deficiency

Hypothalamic-pituitary Disorders

glucagon stimulation test using 1 mg (1.5 mg if weigh >90 kg) glucagon stimulation test using 0.03 mg/kg (maximum dose 3 mg) insulin tolerance test using 0.10-0.15 U/kg ACTH stimulation test in subjects with type 2 diabetes mellitus (T2DM), coronary artery disease (CAD), cerebrovascular disease (CVD), seizure

Glucagon stimulation test and insulin tolerance test

glucagon stimulation test using 1 mg (1.5 mg if weigh >90 kg) glucagon stimulation test using 0.03 mg/kg (maximum dose 3 mg) insulin tolerance test using 0.10-0.15 U/kg ACTH stimulation test in subjects with type 2 diabetes mellitus (T2DM), coronary artery disease (CAD), CVD (cerebrovascular disease), seizure

adrenal insufficiency/פרכוס אפילפטי

Decreasing Parental Stress of Caregivers of Infants With Infantile Spasms by Using Telemedicine Technology

The Glucagon Stimulation Test for Evaluation of Adult Growth Hormone Deficiency and Adrenocorticotropic Axis

המאגר השלם ביותר של צמחי מרפא המגובה על ידי המדע