Trial Outcomes & Findings for Comparison of Cortisol Pump With Standard Treatment for Congenital Adrenal Hyperplasia (NCT NCT01859312)
NCT ID: NCT01859312
Last Updated: 2017-12-22
Results Overview
17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency
COMPLETED
PHASE2
8 participants
At baseline
2017-12-22
Participant Flow
Eight adult patients with classic CAH due to 21-hydroxylase deficiency participated in this study. Four were recruited from a pool of 147 patients enrolled on a natural history study at the NIH natural history study (NCT00250159); 4 were recruited through advertisements.
Participant milestones
| Measure |
Continuous Sub-Q Hydrocortisone Infusion
Enrolled participants with congenital adrenal hyperplasia (CAH) received continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to achieve near-physiologic cortisol replacement therapy
Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Cortisol Pump With Standard Treatment for Congenital Adrenal Hyperplasia
Baseline characteristics by cohort
| Measure |
Continuous Sub-Q Hydrocortisone Infusion
n=8 Participants
Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy
Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
3 Participants
n=5 Participants
|
|
Phenotype
Simple Virilizing (SV)
|
2 Participants
n=5 Participants
|
|
Phenotype
Salt-wasting (SW)
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At baseline17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency
Outcome measures
| Measure |
Continuous Subcutaneous Hydrocortisone Infusion
n=8 Participants
Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy
Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
|
|---|---|
|
Number of Patients With 17-OHP Levels Equal or Below 1,200 ng/dL at 0700
|
0 Participants
|
PRIMARY outcome
Timeframe: At 6 months17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency
Outcome measures
| Measure |
Continuous Subcutaneous Hydrocortisone Infusion
n=8 Participants
Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy
Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
|
|---|---|
|
Number of Patients With 17-OH Progesterone Levels Equal or Below 1,200 ng/dL at 0700
|
3 Participants
|
SECONDARY outcome
Timeframe: At baseline17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency
Outcome measures
| Measure |
Continuous Subcutaneous Hydrocortisone Infusion
n=8 Participants
Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy
Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
|
|---|---|
|
Participants Mean Level of 17-OHP at 0700
|
8313 ng/dL
Standard Error 2748
|
SECONDARY outcome
Timeframe: At 6 months17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency
Outcome measures
| Measure |
Continuous Subcutaneous Hydrocortisone Infusion
n=8 Participants
Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy
Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
|
|---|---|
|
Participants Mean Level of 17-OHP at 0700
|
2150 ng/dL
Standard Error 531
|
SECONDARY outcome
Timeframe: At baseline17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Outcome measures
| Measure |
Continuous Subcutaneous Hydrocortisone Infusion
n=8 Participants
Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy
Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
|
|---|---|
|
Participants Mean Level of 17-OHP Area Under the Curve (AUC) - 24 Hours
|
98.5 h*mcg/dL
Standard Error 39.3
|
SECONDARY outcome
Timeframe: At 6 months17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Outcome measures
| Measure |
Continuous Subcutaneous Hydrocortisone Infusion
n=8 Participants
Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy
Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
|
|---|---|
|
Participants Mean Level of 17-OHP Area Under the Curve (AUC) - 24 Hours
|
25.7 h*mcg/dL
Standard Error 9.5
|
SECONDARY outcome
Timeframe: At baseline17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Outcome measures
| Measure |
Continuous Subcutaneous Hydrocortisone Infusion
n=8 Participants
Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy
Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
|
|---|---|
|
Participants Mean Level of 17-OHP Area Under the Curve (AUC) - Daytime (0700-1500)
|
48.6 h*mcg/dL
Standard Error 22.4
|
SECONDARY outcome
Timeframe: At 6 months17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Outcome measures
| Measure |
Continuous Subcutaneous Hydrocortisone Infusion
n=8 Participants
Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy
Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
|
|---|---|
|
Participants Mean Level of 17-OHP Area Under the Curve (AUC) - Daytime (0700-1500)
|
6.8 h*mcg/dL
Standard Error 1.8
|
SECONDARY outcome
Timeframe: At baseline17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficienc. AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Outcome measures
| Measure |
Continuous Subcutaneous Hydrocortisone Infusion
n=8 Participants
Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy
Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
|
|---|---|
|
Participants Mean Level of 17-OHP Area Under the Curve (AUC) - Midday (1500 - 2300)
|
20.5 h*mcg/dL
Standard Error 6.8
|
SECONDARY outcome
Timeframe: At 6 months17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Outcome measures
| Measure |
Continuous Subcutaneous Hydrocortisone Infusion
n=8 Participants
Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy
Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
|
|---|---|
|
Participants Mean Level of 17-OHP Area Under the Curve (AUC) - Midday (1500 - 2300)
|
7.5 h*mcg/dL
Standard Error 4.9
|
SECONDARY outcome
Timeframe: At baseline17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Outcome measures
| Measure |
Continuous Subcutaneous Hydrocortisone Infusion
n=8 Participants
Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy
Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
|
|---|---|
|
Participants Mean Level of 17-OHP Area Under the Curve (AUC) - Nighttime (2300 - 0700)
|
29.5 h*mcg/dL
Standard Error 11.1
|
SECONDARY outcome
Timeframe: At 6 months17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Outcome measures
| Measure |
Continuous Subcutaneous Hydrocortisone Infusion
n=8 Participants
Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy
Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
|
|---|---|
|
Participants Mean Level of 17-OHP Area Under the Curve (AUC) - Nighttime (2300 - 0700)
|
11.4 h*mcg/dL
Standard Error 3.0
|
SECONDARY outcome
Timeframe: At baselineParticipants Mean Level of Androstenedione at 0700.
Outcome measures
| Measure |
Continuous Subcutaneous Hydrocortisone Infusion
n=8 Participants
Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy
Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
|
|---|---|
|
Participants Mean Level of Androstenedione at 0700
|
748 ng/dL
Standard Error 295
|
SECONDARY outcome
Timeframe: At 6 monthsParticipants Mean Level of Androstenedione at 0700.
Outcome measures
| Measure |
Continuous Subcutaneous Hydrocortisone Infusion
n=8 Participants
Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy
Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
|
|---|---|
|
Participants Mean Level of Androstenedione at 0700
|
317 ng/dL
Standard Error 77
|
SECONDARY outcome
Timeframe: At baselineParticipants Mean Level of Androstenedione Area Under the Curve (AUC) - 24 hours. AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Outcome measures
| Measure |
Continuous Subcutaneous Hydrocortisone Infusion
n=8 Participants
Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy
Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
|
|---|---|
|
Participants Mean Level of Androstenedione Area Under the Curve (AUC) - 24 Hours
|
12.7 h*mcg/dL
Standard Error 4.5
|
SECONDARY outcome
Timeframe: At 6 monthsParticipants Mean Level of Androstenedione area under the curve (AUC) - 24 hours. AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Outcome measures
| Measure |
Continuous Subcutaneous Hydrocortisone Infusion
n=8 Participants
Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy
Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
|
|---|---|
|
Participants Mean Level of Androstenedione Area Under the Curve (AUC) - 24 Hours
|
5.2 h*mcg/dL
Standard Error 1.4
|
SECONDARY outcome
Timeframe: At baselineParticipants Mean Level of Androstenedione Area Under the Curve (AUC) - Daytime (0700-1500). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Outcome measures
| Measure |
Continuous Subcutaneous Hydrocortisone Infusion
n=8 Participants
Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy
Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
|
|---|---|
|
Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Daytime (0700-1500)
|
5.3 h*mcg/dL
Standard Error 2.1
|
SECONDARY outcome
Timeframe: At 6 monthsParticipants Mean Level of Androstenedione Area Under the Curve (AUC) - Daytime (0700-1500). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Outcome measures
| Measure |
Continuous Subcutaneous Hydrocortisone Infusion
n=8 Participants
Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy
Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
|
|---|---|
|
Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Daytime (0700-1500)
|
1.8 h*mcg/dL
Standard Error 0.4
|
SECONDARY outcome
Timeframe: At baselineParticipants Mean Level of Androstenedione Area Under the Curve (AUC) - Midday (1500 - 2300). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Outcome measures
| Measure |
Continuous Subcutaneous Hydrocortisone Infusion
n=8 Participants
Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy
Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
|
|---|---|
|
Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Midday (1500 - 2300)
|
3.7 h*mcg/dL
Standard Error 1.1
|
SECONDARY outcome
Timeframe: At 6 monthsParticipants Mean Level of Androstenedione Area Under the Curve (AUC) - Midday (1500 - 2300). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Outcome measures
| Measure |
Continuous Subcutaneous Hydrocortisone Infusion
n=8 Participants
Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy
Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
|
|---|---|
|
Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Midday (1500 - 2300)
|
1.6 h*mcg/dL
Standard Error 0.6
|
SECONDARY outcome
Timeframe: At baselineParticipants Mean Level of Androstenedione Area Under the Curve (AUC) - Nighttime (2300 - 0700). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Outcome measures
| Measure |
Continuous Subcutaneous Hydrocortisone Infusion
n=8 Participants
Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy
Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
|
|---|---|
|
Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Nighttime (2300 - 0700)
|
3.7 h*mcg/dL
Standard Error 1.3
|
SECONDARY outcome
Timeframe: At 6 monthsParticipants Mean Level of Androstenedione Area Under the Curve (AUC) - Nighttime (2300 - 0700). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Outcome measures
| Measure |
Continuous Subcutaneous Hydrocortisone Infusion
n=8 Participants
Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy
Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
|
|---|---|
|
Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Nighttime (2300 - 0700)
|
1.8 h*mcg/dL
Standard Error 0.4
|
SECONDARY outcome
Timeframe: At baselineParticipants Mean Level of ACTH at 0700.
Outcome measures
| Measure |
Continuous Subcutaneous Hydrocortisone Infusion
n=8 Participants
Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy
Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
|
|---|---|
|
Participants Mean Level of ACTH at 0700
|
405 pg/mL
Standard Error 114
|
SECONDARY outcome
Timeframe: At 6 monthsParticipants Mean Level of ACTH at 0700.
Outcome measures
| Measure |
Continuous Subcutaneous Hydrocortisone Infusion
n=8 Participants
Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy
Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
|
|---|---|
|
Participants Mean Level of ACTH at 0700
|
139 pg/mL
Standard Error 47
|
SECONDARY outcome
Timeframe: At baselineParticipants Mean Level of ACTH Area Under the Curve (AUC) - 24 Hours. AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300.Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Outcome measures
| Measure |
Continuous Subcutaneous Hydrocortisone Infusion
n=8 Participants
Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy
Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
|
|---|---|
|
Participants Mean Level of ACTH Area Under the Curve (AUC) - 24 Hours
|
2538 h*pg/mL
Standard Error 743
|
SECONDARY outcome
Timeframe: At 6 monthsParticipants Mean Level of ACTH Area Under the Curve (AUC) - 24 Hours. AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Outcome measures
| Measure |
Continuous Subcutaneous Hydrocortisone Infusion
n=8 Participants
Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy
Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
|
|---|---|
|
Participants Mean Level of ACTH Area Under the Curve (AUC) - 24 Hours
|
1087 h*pg/mL
Standard Error 359
|
SECONDARY outcome
Timeframe: At baselineParticipants Mean Level of ACTH Area Under the Curve (AUC) - Daytime (0700-1500). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Outcome measures
| Measure |
Continuous Subcutaneous Hydrocortisone Infusion
n=8 Participants
Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy
Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
|
|---|---|
|
Participants Mean Level of ACTH Area Under the Curve (AUC) - Daytime (0700-1500)
|
1239 h*pg/mL
Standard Error 402
|
SECONDARY outcome
Timeframe: At 6 monthsParticipants Mean Level of ACTH Area Under the Curve (AUC) - Daytime (0700-1500). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Outcome measures
| Measure |
Continuous Subcutaneous Hydrocortisone Infusion
n=8 Participants
Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy
Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
|
|---|---|
|
Participants Mean Level of ACTH Area Under the Curve (AUC) - Daytime (0700-1500)
|
340 h*pg/mL
Standard Error 107
|
SECONDARY outcome
Timeframe: At baselineParticipants Mean Level of ACTH Area Under the Curve (AUC) - Midday (1500 - 2300). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Outcome measures
| Measure |
Continuous Subcutaneous Hydrocortisone Infusion
n=8 Participants
Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy
Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
|
|---|---|
|
Participants Mean Level of ACTH Area Under the Curve (AUC) - Midday (1500 - 2300)
|
458 h*pg/mL
Standard Error 179
|
SECONDARY outcome
Timeframe: At 6 monthsParticipants Mean Level of ACTH Area Under the Curve (AUC) - Midday (1500 - 2300). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Outcome measures
| Measure |
Continuous Subcutaneous Hydrocortisone Infusion
n=8 Participants
Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy
Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
|
|---|---|
|
Participants Mean Level of ACTH Area Under the Curve (AUC) - Midday (1500 - 2300)
|
183 h*pg/mL
Standard Error 55
|
SECONDARY outcome
Timeframe: At baselineParticipants Mean Level of ACTH Area Under the Curve (AUC) - Nighttime (2300 - 0700). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Outcome measures
| Measure |
Continuous Subcutaneous Hydrocortisone Infusion
n=8 Participants
Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy
Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
|
|---|---|
|
Participants Mean Level of ACTH Area Under the Curve (AUC) - Nighttime (2300 - 0700)
|
841 h*pg/mL
Standard Error 233
|
SECONDARY outcome
Timeframe: At 6 monthsParticipants Mean Level of ACTH Area Under the Curve (AUC) - Nighttime (2300 - 0700). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Outcome measures
| Measure |
Continuous Subcutaneous Hydrocortisone Infusion
n=8 Participants
Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy
Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
|
|---|---|
|
Participants Mean Level of ACTH Area Under the Curve (AUC) - Nighttime (2300 - 0700)
|
564 h*pg/mL
Standard Error 216
|
SECONDARY outcome
Timeframe: At baselineParticipants Mean Level of Progesterone at 0700
Outcome measures
| Measure |
Continuous Subcutaneous Hydrocortisone Infusion
n=8 Participants
Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy
Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
|
|---|---|
|
Participants Mean Progesterone Levels at 0700
|
9.5 ng/mL
Standard Error 5.4
|
SECONDARY outcome
Timeframe: At 6 monthsParticipants Mean Level of Progesterone at 0700
Outcome measures
| Measure |
Continuous Subcutaneous Hydrocortisone Infusion
n=8 Participants
Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy
Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
|
|---|---|
|
Participants Mean Progesterone Level at 0700
|
0.8 ng/mL
Standard Error 0.4
|
SECONDARY outcome
Timeframe: At baselineParticipants Mean Level of Progesterone area under the curve (AUC) - 24 hours. AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Outcome measures
| Measure |
Continuous Subcutaneous Hydrocortisone Infusion
n=8 Participants
Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy
Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
|
|---|---|
|
Participants Mean Level of Progesterone Area Under the Curve (AUC) - 24 Hours
|
101.1 h*ng/dL
Standard Error 48.8
|
SECONDARY outcome
Timeframe: At 6 monthsParticipants Mean Level of Progesterone area under the curve (AUC) - 24 hours. AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Outcome measures
| Measure |
Continuous Subcutaneous Hydrocortisone Infusion
n=8 Participants
Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy
Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
|
|---|---|
|
Participants Mean Level of Progesterone Area Under the Curve (AUC) - 24 Hours
|
13.7 h*ng/dL
Standard Error 4.6
|
SECONDARY outcome
Timeframe: At baselineParticipants Mean Level of Progesterone area under the curve (AUC) - Daytime (0700-1500). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Outcome measures
| Measure |
Continuous Subcutaneous Hydrocortisone Infusion
n=8 Participants
Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy
Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
|
|---|---|
|
Participants Mean Level of Progesterone Area Under the Curve (AUC) - Daytime (0700-1500)
|
42.2 h*ng/dL
Standard Error 20.0
|
SECONDARY outcome
Timeframe: At 6 monthsParticipants Mean Level of Progesterone area under the curve (AUC) - Daytime (0700-1500). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Outcome measures
| Measure |
Continuous Subcutaneous Hydrocortisone Infusion
n=8 Participants
Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy
Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
|
|---|---|
|
Participants Mean Level of Progesterone Area Under the Curve (AUC) - Daytime (0700-1500)
|
4.2 h*ng/dL
Standard Error 1.6
|
SECONDARY outcome
Timeframe: At baselineParticipants Mean Level of Progesterone area under the curve (AUC) - Midday (1500 - 2300). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Outcome measures
| Measure |
Continuous Subcutaneous Hydrocortisone Infusion
n=8 Participants
Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy
Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
|
|---|---|
|
Participants Mean Level of Progesterone Area Under the Curve (AUC) - Midday (1500 - 2300)
|
30.7 h*ng/dL
Standard Error 17.7
|
SECONDARY outcome
Timeframe: At 6 monthsParticipants Mean Level of Progesterone area under the curve (AUC) - Midday (1500 - 2300). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Outcome measures
| Measure |
Continuous Subcutaneous Hydrocortisone Infusion
n=8 Participants
Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy
Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
|
|---|---|
|
Participants Mean Level of Progesterone Area Under the Curve (AUC) - Midday (1500 - 2300)
|
5.5 h*ng/dL
Standard Error 3.2
|
SECONDARY outcome
Timeframe: At baselineParticipants Mean Level of Progesterone area under the curve (AUC) - Nighttime (2300 - 0700). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Outcome measures
| Measure |
Continuous Subcutaneous Hydrocortisone Infusion
n=8 Participants
Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy
Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
|
|---|---|
|
Participants Mean Level of Progesterone Area Under the Curve (AUC) - Nighttime (2300 - 0700)
|
28.2 h*ng/dL
Standard Error 12.5
|
SECONDARY outcome
Timeframe: At 6 monthsParticipants Mean Level of Progesterone area under the curve (AUC) - Nighttime (2300 - 0700). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Outcome measures
| Measure |
Continuous Subcutaneous Hydrocortisone Infusion
n=8 Participants
Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy
Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
|
|---|---|
|
Participants Mean Level of Progesterone Area Under the Curve (AUC) - Nighttime (2300 - 0700)
|
4.0 h*ng/dL
Standard Error 0.5
|
SECONDARY outcome
Timeframe: At baselinelean body mass measured by DEXA, Hologic Discovery-A
Outcome measures
| Measure |
Continuous Subcutaneous Hydrocortisone Infusion
n=8 Participants
Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy
Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
|
|---|---|
|
Participant Lean Body Mass
|
60.7 kg
Standard Error 3.7
|
SECONDARY outcome
Timeframe: At 6 monthslean body mass measured by DEXA, Hologic Discovery-A
Outcome measures
| Measure |
Continuous Subcutaneous Hydrocortisone Infusion
n=8 Participants
Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy
Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
|
|---|---|
|
Participant Lean Body Mass
|
64.3 kg
Standard Error 4.4
|
Adverse Events
Continuous Subcutaneous Hydrocortisone Infusion
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Continuous Subcutaneous Hydrocortisone Infusion
n=8 participants at risk
Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy
Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
|
|---|---|
|
Skin and subcutaneous tissue disorders
Skin erythema with pruritis at the infusion set site
|
37.5%
3/8 • At 6 months. Subjects that select the option of continuing CSHI therapy for 1 additional year will be monitored for 1 year, 6 months.
IRB granted a waiver of reporting the following anticipated adverse events (non-UP adverse events) unless they occurring in greater frequency than expected: 1. Local skin reaction (50%) 2. Local skin infection requiring local or antibiotic treatment (10%) 3. Minimal bleeding after removal of the infusion set (90%)
|
|
Skin and subcutaneous tissue disorders
Local skin infection at the infusion set site
|
62.5%
5/8 • At 6 months. Subjects that select the option of continuing CSHI therapy for 1 additional year will be monitored for 1 year, 6 months.
IRB granted a waiver of reporting the following anticipated adverse events (non-UP adverse events) unless they occurring in greater frequency than expected: 1. Local skin reaction (50%) 2. Local skin infection requiring local or antibiotic treatment (10%) 3. Minimal bleeding after removal of the infusion set (90%)
|
|
Nervous system disorders
Dizziness
|
62.5%
5/8 • At 6 months. Subjects that select the option of continuing CSHI therapy for 1 additional year will be monitored for 1 year, 6 months.
IRB granted a waiver of reporting the following anticipated adverse events (non-UP adverse events) unless they occurring in greater frequency than expected: 1. Local skin reaction (50%) 2. Local skin infection requiring local or antibiotic treatment (10%) 3. Minimal bleeding after removal of the infusion set (90%)
|
|
Nervous system disorders
Lightheadedness
|
62.5%
5/8 • At 6 months. Subjects that select the option of continuing CSHI therapy for 1 additional year will be monitored for 1 year, 6 months.
IRB granted a waiver of reporting the following anticipated adverse events (non-UP adverse events) unless they occurring in greater frequency than expected: 1. Local skin reaction (50%) 2. Local skin infection requiring local or antibiotic treatment (10%) 3. Minimal bleeding after removal of the infusion set (90%)
|
|
Musculoskeletal and connective tissue disorders
Weakness
|
37.5%
3/8 • At 6 months. Subjects that select the option of continuing CSHI therapy for 1 additional year will be monitored for 1 year, 6 months.
IRB granted a waiver of reporting the following anticipated adverse events (non-UP adverse events) unless they occurring in greater frequency than expected: 1. Local skin reaction (50%) 2. Local skin infection requiring local or antibiotic treatment (10%) 3. Minimal bleeding after removal of the infusion set (90%)
|
|
General disorders
Fatigue
|
87.5%
7/8 • At 6 months. Subjects that select the option of continuing CSHI therapy for 1 additional year will be monitored for 1 year, 6 months.
IRB granted a waiver of reporting the following anticipated adverse events (non-UP adverse events) unless they occurring in greater frequency than expected: 1. Local skin reaction (50%) 2. Local skin infection requiring local or antibiotic treatment (10%) 3. Minimal bleeding after removal of the infusion set (90%)
|
|
Gastrointestinal disorders
Nausea
|
25.0%
2/8 • At 6 months. Subjects that select the option of continuing CSHI therapy for 1 additional year will be monitored for 1 year, 6 months.
IRB granted a waiver of reporting the following anticipated adverse events (non-UP adverse events) unless they occurring in greater frequency than expected: 1. Local skin reaction (50%) 2. Local skin infection requiring local or antibiotic treatment (10%) 3. Minimal bleeding after removal of the infusion set (90%)
|
|
Nervous system disorders
Headache
|
87.5%
7/8 • At 6 months. Subjects that select the option of continuing CSHI therapy for 1 additional year will be monitored for 1 year, 6 months.
IRB granted a waiver of reporting the following anticipated adverse events (non-UP adverse events) unless they occurring in greater frequency than expected: 1. Local skin reaction (50%) 2. Local skin infection requiring local or antibiotic treatment (10%) 3. Minimal bleeding after removal of the infusion set (90%)
|
|
Musculoskeletal and connective tissue disorders
Carpal tunnel
|
12.5%
1/8 • At 6 months. Subjects that select the option of continuing CSHI therapy for 1 additional year will be monitored for 1 year, 6 months.
IRB granted a waiver of reporting the following anticipated adverse events (non-UP adverse events) unless they occurring in greater frequency than expected: 1. Local skin reaction (50%) 2. Local skin infection requiring local or antibiotic treatment (10%) 3. Minimal bleeding after removal of the infusion set (90%)
|
|
Musculoskeletal and connective tissue disorders
Knee pain when walking
|
12.5%
1/8 • At 6 months. Subjects that select the option of continuing CSHI therapy for 1 additional year will be monitored for 1 year, 6 months.
IRB granted a waiver of reporting the following anticipated adverse events (non-UP adverse events) unless they occurring in greater frequency than expected: 1. Local skin reaction (50%) 2. Local skin infection requiring local or antibiotic treatment (10%) 3. Minimal bleeding after removal of the infusion set (90%)
|
|
Ear and labyrinth disorders
Tinnutus
|
12.5%
1/8 • At 6 months. Subjects that select the option of continuing CSHI therapy for 1 additional year will be monitored for 1 year, 6 months.
IRB granted a waiver of reporting the following anticipated adverse events (non-UP adverse events) unless they occurring in greater frequency than expected: 1. Local skin reaction (50%) 2. Local skin infection requiring local or antibiotic treatment (10%) 3. Minimal bleeding after removal of the infusion set (90%)
|
|
Gastrointestinal disorders
Decreased appetite
|
25.0%
2/8 • At 6 months. Subjects that select the option of continuing CSHI therapy for 1 additional year will be monitored for 1 year, 6 months.
IRB granted a waiver of reporting the following anticipated adverse events (non-UP adverse events) unless they occurring in greater frequency than expected: 1. Local skin reaction (50%) 2. Local skin infection requiring local or antibiotic treatment (10%) 3. Minimal bleeding after removal of the infusion set (90%)
|
|
Gastrointestinal disorders
Increased appetite
|
75.0%
6/8 • At 6 months. Subjects that select the option of continuing CSHI therapy for 1 additional year will be monitored for 1 year, 6 months.
IRB granted a waiver of reporting the following anticipated adverse events (non-UP adverse events) unless they occurring in greater frequency than expected: 1. Local skin reaction (50%) 2. Local skin infection requiring local or antibiotic treatment (10%) 3. Minimal bleeding after removal of the infusion set (90%)
|
|
General disorders
Difficulty falling asleep or frequent wakening
|
62.5%
5/8 • At 6 months. Subjects that select the option of continuing CSHI therapy for 1 additional year will be monitored for 1 year, 6 months.
IRB granted a waiver of reporting the following anticipated adverse events (non-UP adverse events) unless they occurring in greater frequency than expected: 1. Local skin reaction (50%) 2. Local skin infection requiring local or antibiotic treatment (10%) 3. Minimal bleeding after removal of the infusion set (90%)
|
|
General disorders
Early morning wakening
|
37.5%
3/8 • At 6 months. Subjects that select the option of continuing CSHI therapy for 1 additional year will be monitored for 1 year, 6 months.
IRB granted a waiver of reporting the following anticipated adverse events (non-UP adverse events) unless they occurring in greater frequency than expected: 1. Local skin reaction (50%) 2. Local skin infection requiring local or antibiotic treatment (10%) 3. Minimal bleeding after removal of the infusion set (90%)
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|
Skin and subcutaneous tissue disorders
Increased acne
|
25.0%
2/8 • At 6 months. Subjects that select the option of continuing CSHI therapy for 1 additional year will be monitored for 1 year, 6 months.
IRB granted a waiver of reporting the following anticipated adverse events (non-UP adverse events) unless they occurring in greater frequency than expected: 1. Local skin reaction (50%) 2. Local skin infection requiring local or antibiotic treatment (10%) 3. Minimal bleeding after removal of the infusion set (90%)
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General disorders
Weight gain
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62.5%
5/8 • At 6 months. Subjects that select the option of continuing CSHI therapy for 1 additional year will be monitored for 1 year, 6 months.
IRB granted a waiver of reporting the following anticipated adverse events (non-UP adverse events) unless they occurring in greater frequency than expected: 1. Local skin reaction (50%) 2. Local skin infection requiring local or antibiotic treatment (10%) 3. Minimal bleeding after removal of the infusion set (90%)
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Additional Information
Deborah P. Merke, MD, MS
National Institute of Child Health and Human Development (NICHD)
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place