Adrenal Insufficiency, CongenitalGLYSURNCT04322435
Prevalence of Hypoglycaemia in Congenital Adrenal Insufficiency
A study testing Continuous blood glucose measurement and Measurement of capillary blood glucose in people with Adrenal Insufficiency, Congenital, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 6 years
- Conditions the study is for
- Adrenal Insufficiency, Congenital
- What is being tested?
- Continuous blood glucose measurement and Measurement of capillary blood glucose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jul 2020to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Adrenal Insufficiency, Congenital
- Being tested
- Continuous blood glucose measurement, Measurement of capillary blood glucose
- Keywords
- Congenital primary and secondary adrenal insufficiency, Cortisol deficiency, Hypoglycaemia, Children
- Medical subject headings
- Adrenal Insufficiency, Congenital, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous blood glucose measurementOther
Continuous blood glucose measurement with Abbott Freestyle Pro for 14 days, repeated twice at 6 months intervals.
Measurement of capillary blood glucoseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Adrenal insufficiency | Other | Patients followed in the paediatric endocrinology department of the Necker Hospital, with primary and secondary adrenal insufficiency, aged from 6 months to 6 years. Receives: Other: Continuous blood glucose measurement; Other: Measurement of capillary blood glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 year
Secondary outcomes (18)
Duration of hypoglycaemia
Time in hypoglycaemia measured in minutes per day during the continuous blood glucose measurements.
Measured: 1 year
Percentage of time in hypoglycaemia
Percentage of time in hypoglycaemia during the continuous blood glucose measurements.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
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).
Measured: 1 year
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
Measured: 1 year
Systolic and Diastolic Blood Pressure
Expressed millimetre of mercury
Measured: 1 year
Heart rate
Number of beats per minute
Measured: 1 year
Stade tanner
stade tanner A1 to A5
Measured: 1 year
Amount of salt consumed per day
Number of grams per day
Measured: 1 year
Cortisol at 8 a.m.
microgram / deciliter
Measured: 1 year
Cycle of 17-hydroxyprogesterone
Nanomole per liter
Measured: 1 year
Adreno CorticoTropic Hormone
Nanogram per liter
Measured: 1 year
17-hydroxyprogesterone
Nanomole per liter
Measured: 1 year
Delta-4-Androstenedione
Nanomole per liter
Measured: 1 year
Testosterone
Nanomole per liter
Measured: 1 year
Ionogram
Nanomole per liter
Measured: 1 year
Renin
picogram/milliliter
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start15 Jul 2020
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adrenal Insufficiency, CongenitalStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Dinane Samara-Boustani, MD, Principal investigator, Assistance Publique - Hôpitaux de ParisMichel Polak, MD, PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04322435
- Sponsor's protocol ID
- APHP190910
- Other IDs
- ID RCB 2019-A02250-57
- Acronym
- GLYSUR
- Status last verified
- Mar 2026
- First submitted
- 15 Nov 2019
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Galderisi A, Kariyawasam D, Stoupa A, Quoc AN, Pinto G, Viaud M, Brabant S, Beltrand J, Polak M, Samara-Boustani D. Glucose pattern in children with classical congenital adrenal hyperplasia: evidence from continuous glucose monitoring. Eur J Endocrinol. 2023 Nov 8;189(5):K19-K24. doi: 10.1093/ejendo/lvad147.
PubMed 37952170
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Hypoglycaemia in Congenital Adrenal Insufficiency
- ClinicalTrials.gov ID
- NCT04322435
- Acronym / sponsor ID
- GLYSUR / APHP190910
- Conditions
- Adrenal Insufficiency, Congenital
- Keywords
- Congenital primary and secondary adrenal insufficiency, Cortisol deficiency, Hypoglycaemia, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 26 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adrenal insufficiency | Other | Other: Continuous blood glucose measurement, Other: Measurement of capillary blood glucosePatients followed in the paediatric endocrinology department of the Necker Hospital, with primary and secondary adrenal insufficiency, aged from 6 months to 6 years. |
Who may qualify
- Ages
- 6 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous blood glucose measurementContinuous blood glucose measurement with Abbott Freestyle Pro for 14 days, repeated twice at 6 months intervals. | Other | Adrenal insufficiency |
| Measurement of capillary blood glucoseMeasurement 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. | Other | Adrenal insufficiency |
Primary outcome
Prevalence of hypoglycaemia
Time frame: 1 year
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).
18 secondary outcomes
Duration of hypoglycaemia
Time frame: 1 year
Percentage of time in hypoglycaemia
Time frame: 1 year
Glycemic variations rate
Time frame: 1 year
Circumstances of occurrence of hypoglycaemia
Time frame: 1 year
Occurrence of medical events
Time frame: 1 year
Body Mass Index
Time frame: 1 year
Systolic and Diastolic Blood Pressure
Time frame: 1 year
Heart rate
Time frame: 1 year
Stade tanner
Time frame: 1 year
Amount of salt consumed per day
Time frame: 1 year
Cortisol at 8 a.m.
Time frame: 1 year
Cycle of 17-hydroxyprogesterone
Time frame: 1 year
Adreno CorticoTropic Hormone
Time frame: 1 year
17-hydroxyprogesterone
Time frame: 1 year
Delta-4-Androstenedione
Time frame: 1 year
Testosterone
Time frame: 1 year
Ionogram
Time frame: 1 year
Renin
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Results publication: PubMed 37952170Galderisi A, Kariyawasam D, Stoupa A, Quoc AN, Pinto G, Viaud M, Brabant S, Beltrand J, Polak M, Samara-Boustani D. Glucose pattern in children with classical congenital adrenal hyperplasia: evidence from continuous glucose monitoring. Eur J Endocrinol. 2023 Nov 8;189(5):K19-K24. doi: 10.1093/ejendo/lvad147.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dinane Samara-Boustani, MD principal investigator
Assistance Publique - Hôpitaux de Paris
Michel Polak, MD, PhD study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous blood glucose measurement and Measurement of capillary blood glucose in people with Adrenal Insufficiency, Congenital, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of hypoglycaemia (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04322435, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.