The effect of prednisolone versus hydrocortisone as glucocorticoid replacement therapy on hypoglycaemia frequency in people with Type 1 diabetes and adrenal insufficiency.

The effect of prednisolone versus hydrocortisone as glucocorticoid replacement therapy on hypoglycaemia frequency in people with Type 1 diabetes and adrenal insufficiency: a pilot study. - Hypoglycaemia frequency in people with Type 1 diabetes and adrenal insufficiency.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-002336-15-GB

Enrollment

Registered

2011-05-25

Start date

2011-08-31

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 diabetes and adrenal insufficiency. MedDRA version: 13.1 Level: PT Classification code 10001367 Term: Adrenal insufficiency System Organ Class: 10014698 - Endocrine disorders MedDRA version: 13.1 Level: PT Classification code 10067584 Term: Type 1 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorder

Interventions

Product Name: Prednisolone Pharmaceutical Form: Tablet INN or Proposed INN: PREDNISOLONE CAS Number: 50-24-8 Concentration unit: mg mill

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Able to provide informed consent to participate in the study 2. Age 18 or over 3. Type 1 diabetes. 4. On current insulin regimen for at least 4 weeks. 5. Understanding of the principles of self-adjustment of insulin regimen on the basis of self blood glucose monitoring results. 6. Adrenal insufficiency 7. On current hydrocortisone regimen for at least 2 months. 8. Normal thyroid function or on appropriate thyroxine replacement. 9. With or without problematic hypoglycaemia. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 16 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 16

Exclusion criteria

Exclusion criteria: 1. Inability to give informed consent 2. Age less than 18 years 3. Pregnancy or breastfeeding 4. Currently enrolled in other clinical study 5. Islet transplant / pancreatic transplant 6. Other steroid treatment (except inhalers and topical steroids) 7. Unstable angina, myocardial infarction, uncontrolled congestive cardiac failure in the previous year 8. Recent history of cancer (1.5 or platelets less than 50x109/L) 12. Anaemia (Hb less than 10g/dL, except stable haemoglobinopathy)

Design outcomes

Primary

Measure	Time frame
Main Objective: In people with type 1 diabetes and adrenal insufficiency, who are established on hydrocortisone as glucocorticoid replacement, frequency of nocturnal hypoglycaemia will be reduced by changing the glucocorticoid replacement from hydrocortisone to prednisolone;Timepoint(s) of evaluation of this end point: Throughout 10 weeks of study; Secondary Objective: The secondary objectives of this study are to investigate the hypotheses that in people with type 1 diabetes and adrenal insufficiency, who are established on hydrocortisone as glucocorticoid replacement, changing the glucocorticoid replacement from hydrocortisone to prednisolone will: 1. Reduce overall frequency of moderate biochemical hypoglycaemia. 2. Reduce total moderate biochemical hypoglycaemia exposure. 3. Reduce the proportion of participants experiencing at least one episode of moderate biochemical hypoglycaemia during Continuous Glucose Monitoring (CGM). 4. Reduce hypoglycaemia burden score based on self-reporting of hypoglycaemia episodes over a four-week period (modified from Ryan et al (Ryan et al., 2004)). 5. Improve hypoglycaemia awareness, as assessed by Clarke score and Gold score (Gold et al., 1994, Clarke et al., 1995). 6. Improve Hypoglycaemia Fear Survey score (Cox et al., 1987). ;Primary end point(s): A difference between the prednisolone and the hydrocortisone phase in the frequency of moderate nocturnal biochemical hypoglycaemia measured by continuous blood glucose monitoring (CGMS) which measures interstitial glucose concentrations and defined as episodes of low interstitial glucose (LIG) <3.0 mmol/l for = 20 mins occurring between 00:00-08:00h and expressed as episodes per week.	—

Measure

Time frame

Main Objective: In people with type 1 diabetes and adrenal insufficiency, who are established on hydrocortisone as glucocorticoid replacement, frequency of nocturnal hypoglycaemia will be reduced by changing the glucocorticoid replacement from hydrocortisone to prednisolone;Timepoint(s) of evaluation of this end point: Throughout 10 weeks of study; Secondary Objective: The secondary objectives of this study are to investigate the hypotheses that in people with type 1 diabetes and adrenal insufficiency, who are established on hydrocortisone as glucocorticoid replacement, changing the glucocorticoid replacement from hydrocortisone to prednisolone will: 1. Reduce overall frequency of moderate biochemical hypoglycaemia. 2. Reduce total moderate biochemical hypoglycaemia exposure. 3. Reduce the proportion of participants experiencing at least one episode of moderate biochemical hypoglycaemia during Continuous Glucose Monitoring (CGM). 4. Reduce hypoglycaemia burden score based on self-reporting of hypoglycaemia episodes over a four-week period (modified from Ryan et al (Ryan et al., 2004)). 5. Improve hypoglycaemia awareness, as assessed by Clarke score and Gold score (Gold et al., 1994, Clarke et al., 1995). 6. Improve Hypoglycaemia Fear Survey score (Cox et al., 1987). ;Primary end point(s): A difference between the prednisolone and the hydrocortisone phase in the frequency of moderate nocturnal biochemical hypoglycaemia measured by continuous blood glucose monitoring (CGMS) which measures interstitial glucose concentrations and defined as episodes of low interstitial glucose (LIG) <3.0 mmol/l for = 20 mins occurring between 00:00-08:00h and expressed as episodes per week.

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Throughout 10 weeks of study; Secondary end point(s): A difference between the prednisolone and the hydrocortisone phase in: 1. Overall (daytime and nighttime) frequency of episodes (lasting = 20 mins) of moderate (LIG<3.0mmol/l) biochemical hypoglycaemia (measured by CGMS). 2. Total moderate biochemical hypoglycaemia exposure (area above the curve calculated from CGMS data). 3. Proportion of participants experiencing at least one episode of moderate biochemical hypoglycaemia during CGM. 4. Hypoglycaemia burden score based on self-reporting of hypoglycaemia episodes over a four-week period [modified from Ryan et al (Ryan et al., 2004). 5. Hypoglycaemia awareness, as assessed by Clarke score and Gold score (Clarke et al., 1995, Gold et al., 1994). 6. Hypoglycaemia Fear Survey score (Cox et al., 1987).	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: Throughout 10 weeks of study; Secondary end point(s): A difference between the prednisolone and the hydrocortisone phase in: 1. Overall (daytime and nighttime) frequency of episodes (lasting = 20 mins) of moderate (LIG<3.0mmol/l) biochemical hypoglycaemia (measured by CGMS). 2. Total moderate biochemical hypoglycaemia exposure (area above the curve calculated from CGMS data). 3. Proportion of participants experiencing at least one episode of moderate biochemical hypoglycaemia during CGM. 4. Hypoglycaemia burden score based on self-reporting of hypoglycaemia episodes over a four-week period [modified from Ryan et al (Ryan et al., 2004). 5. Hypoglycaemia awareness, as assessed by Clarke score and Gold score (Clarke et al., 1995, Gold et al., 1994). 6. Hypoglycaemia Fear Survey score (Cox et al., 1987).

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Countries

United Kingdom

Contacts

Public ContactProf Stephanie Amiel

King's College London

stephanie.amiel@kcl.ac.uk+440207848 5639

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026