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Prevalence of Hypoglycaemia in Congenital Adrenal Insufficiency (GLYSUR)

Primary Purpose

Adrenal Insufficiency, Congenital

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Continuous blood glucose measurement
Measurement of capillary blood glucose
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Adrenal Insufficiency, Congenital focused on measuring Congenital primary and secondary adrenal insufficiency, Cortisol deficiency, Hypoglycaemia, Children

Eligibility Criteria

6 Months - 6 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All male and female patients, followed in the Paediatric Endocrinology Department at Necker Hospital, with congenital primary and secondary adrenal insufficiency.
  • Age between 6 months and 6 years.
  • Included in the social security system.
  • Parental consent and willingness to participate in this study: involves training and skills in the use of blood glucometers.

Exclusion Criteria:

  • Patients with acquired adrenal insufficiency.
  • Patients with type 1 or type 2 diabetes.
  • Patients with somatotropic deficiency associated with adrenal insufficiency.
  • Refusal or impossibility to perform the glycaemic measurements according to the procedure of the study.
  • Not covered by the social security system.

Sites / Locations

  • Hôpital Necker-Enfants Malades

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Adrenal insufficiency

Arm Description

Patients followed in the paediatric endocrinology department of the Necker Hospital, with primary and secondary adrenal insufficiency, aged from 6 months to 6 years.

Outcomes

Primary Outcome Measures

Prevalence of hypoglycaemia
Number of hypoglycaemic events. Hypoglycaemia will be defined by a glucose level measured at a glucose level of less than or equal to 0.55 g /L (3 mmol /L).

Secondary Outcome Measures

Duration of hypoglycaemia
Time in hypoglycaemia measured in minutes per day during the continuous blood glucose measurements.
Percentage of time in hypoglycaemia
Percentage of time in hypoglycaemia during the continuous blood glucose measurements.
Glycemic variations rate
Glycemic variations rate during the different measurements times: minimum rate, maximum rate, average, median. Each result will be expressed in g /L or in mmol /L. Each date will expressed by one day and for one week.
Circumstances of occurrence of hypoglycaemia
Circumstances in which hypoglycaemia occurred : descriptive data by parents, symptomatic or not symptomatic hypoglycaemia, descriptive signs if they are presents.
Occurrence of medical events
Events during the follow-up of the study: modification of treatment of hydrocortisone and fludrocortisone, re-sugaring expressed in number of sugar cubes ( by sugar cube = 20 gr of sugar) or type of sweet food given to the child, hospitalizations ( type and reason for hospitalization, cause of the decompensation).
Body Mass Index
Body mass divided by the square of the body height expressed in units of kg/m2 : mass in kilograms and height in meters
Systolic and Diastolic Blood Pressure
Expressed millimetre of mercury
Heart rate
Number of beats per minute
Stade tanner
stade tanner A1 to A5
Amount of salt consumed per day
Number of grams per day
Cortisol at 8 a.m.
microgram / deciliter
Cycle of 17-hydroxyprogesterone
Nanomole per liter
Adreno CorticoTropic Hormone
Nanogram per liter
17-hydroxyprogesterone
Nanomole per liter
Delta-4-Androstenedione
Nanomole per liter
Testosterone
Nanomole per liter
Ionogram
Nanomole per liter
Renin
picogram/milliliter

Full Information

First Posted
November 15, 2019
Last Updated
January 12, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT04322435
Brief Title
Prevalence of Hypoglycaemia in Congenital Adrenal Insufficiency
Acronym
GLYSUR
Official Title
Prevalence of Hypoglycaemia in Congenital Adrenal Insufficiency
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
July 15, 2020 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
August 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Children with congenital primary and secondary adrenal insufficiency, who are deficient in cortisol, are at risk for hypoglycaemia, irrespective of appropriate hydrocortisone treatment, which can lead to potentially serious neurological complications. Few series are described in pediatrics. The prevalence of hypoglycaemia is probably underestimated because it is often asymptomatic and capillary blood glucose monitoring is not always performed routinely. The objective of the study is to evaluate the prevalence of hypoglycaemia in children with adrenal insufficiency.
Detailed Description
Children with congenital primary and secondary adrenal insufficiency, who are deficient in cortisol, are at risk for hypoglycaemia, irrespective of appropriate hydrocortisone treatment, which can lead to potentially serious neurological complications. Few series are described in pediatrics. The prevalence of hypoglycaemia is underestimated because it is often asymptomatic and capillary blood glucose monitoring is not always performed routinely. The objective of the study is to evaluate the prevalence of hypoglycaemia in children with congenital adrenal insufficiency. The study will follow for one year children from 6 months to 6 years, with central and peripheral adrenal insufficiency. 4 study times are planned with two measurement methods: Continuous blood glucose measurement with Abbott Freestyle Pro for 14 days, repeated twice at 6 months intervals. Measurement of capillary blood glucose, in the morning on an empty stomach, every first week of each month for 12 months, with Abbott's Freestyle optium neo reader, used with the Accu-Chek FastClix lancing device and the test strips Accu-Chek performed. Measurement of capillary glycaemia in case of suspicion of hypoglycaemia. Measure left free according to the judgment of the parents of the necessary character or not. With Abbott's Freestyle optium neo reader, used with the Accu-Chek FastClix lancing device and the Accu-Chek performa strips.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adrenal Insufficiency, Congenital
Keywords
Congenital primary and secondary adrenal insufficiency, Cortisol deficiency, Hypoglycaemia, Children

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adrenal insufficiency
Arm Type
Other
Arm Description
Patients followed in the paediatric endocrinology department of the Necker Hospital, with primary and secondary adrenal insufficiency, aged from 6 months to 6 years.
Intervention Type
Other
Intervention Name(s)
Continuous blood glucose measurement
Intervention Description
Continuous blood glucose measurement with Abbott Freestyle Pro for 14 days, repeated twice at 6 months intervals.
Intervention Type
Other
Intervention Name(s)
Measurement of capillary blood glucose
Intervention Description
Measurement of capillary blood glucose : In the morning on an empty stomach, every first week of each month for 12 months. In case of suspicion of hypoglycaemia (parental assessment). Abbott's Freestyle optium neo reader, used with the Accu-Chek FastClix lancing device and the Accu-Chek Performa strips.
Primary Outcome Measure Information:
Title
Prevalence of hypoglycaemia
Description
Number of hypoglycaemic events. Hypoglycaemia will be defined by a glucose level measured at a glucose level of less than or equal to 0.55 g /L (3 mmol /L).
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Duration of hypoglycaemia
Description
Time in hypoglycaemia measured in minutes per day during the continuous blood glucose measurements.
Time Frame
1 year
Title
Percentage of time in hypoglycaemia
Description
Percentage of time in hypoglycaemia during the continuous blood glucose measurements.
Time Frame
1 year
Title
Glycemic variations rate
Description
Glycemic variations rate during the different measurements times: minimum rate, maximum rate, average, median. Each result will be expressed in g /L or in mmol /L. Each date will expressed by one day and for one week.
Time Frame
1 year
Title
Circumstances of occurrence of hypoglycaemia
Description
Circumstances in which hypoglycaemia occurred : descriptive data by parents, symptomatic or not symptomatic hypoglycaemia, descriptive signs if they are presents.
Time Frame
1 year
Title
Occurrence of medical events
Description
Events during the follow-up of the study: modification of treatment of hydrocortisone and fludrocortisone, re-sugaring expressed in number of sugar cubes ( by sugar cube = 20 gr of sugar) or type of sweet food given to the child, hospitalizations ( type and reason for hospitalization, cause of the decompensation).
Time Frame
1 year
Title
Body Mass Index
Description
Body mass divided by the square of the body height expressed in units of kg/m2 : mass in kilograms and height in meters
Time Frame
1 year
Title
Systolic and Diastolic Blood Pressure
Description
Expressed millimetre of mercury
Time Frame
1 year
Title
Heart rate
Description
Number of beats per minute
Time Frame
1 year
Title
Stade tanner
Description
stade tanner A1 to A5
Time Frame
1 year
Title
Amount of salt consumed per day
Description
Number of grams per day
Time Frame
1 year
Title
Cortisol at 8 a.m.
Description
microgram / deciliter
Time Frame
1 year
Title
Cycle of 17-hydroxyprogesterone
Description
Nanomole per liter
Time Frame
1 year
Title
Adreno CorticoTropic Hormone
Description
Nanogram per liter
Time Frame
1 year
Title
17-hydroxyprogesterone
Description
Nanomole per liter
Time Frame
1 year
Title
Delta-4-Androstenedione
Description
Nanomole per liter
Time Frame
1 year
Title
Testosterone
Description
Nanomole per liter
Time Frame
1 year
Title
Ionogram
Description
Nanomole per liter
Time Frame
1 year
Title
Renin
Description
picogram/milliliter
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All male and female patients, followed in the Paediatric Endocrinology Department at Necker Hospital, with congenital primary and secondary adrenal insufficiency. Age between 6 months and 6 years. Included in the social security system. Parental consent and willingness to participate in this study: involves training and skills in the use of blood glucometers. Exclusion Criteria: Patients with acquired adrenal insufficiency. Patients with type 1 or type 2 diabetes. Patients with somatotropic deficiency associated with adrenal insufficiency. Refusal or impossibility to perform the glycaemic measurements according to the procedure of the study. Not covered by the social security system.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dinane Samara-Boustani, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michel Polak, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Study Director
Facility Information:
Facility Name
Hôpital Necker-Enfants Malades
City
Paris
ZIP/Postal Code
75015
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Prevalence of Hypoglycaemia in Congenital Adrenal Insufficiency

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