Hypoglycaemia (Low Blood Sugar) in Adults With Diabetes and Adrenal Failure

NCT05806190 | Completed FDA Device

• 1 other identifier: 22SM8022
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to measure how often low blood sugars occur in people who live with both adrenal insufficiency (AI) and diabetes and need to take insulin. People who live with AI need to take steroid replacement tablets every day, for life. Two of the most common types of steroid replacement tablets are called prednisolone and hydrocortisone. Low blood sugar (hypoglycemia) is a very common side effect of taking insulin and can often be unpleasant, frightening and dangerous. People who have adrenal failure are also at risk of hypoglycaemia, although this is rare. It is not known whether taking steroids affects how often hypoglycaemia happens. The study has three aims:

1. 1.To measure how often low blood sugars occur at night in people who live with with both adrenal insufficiency (AI) and insulin-treated diabetes
2. 2.To compare how often low blood sugars occur in people taking prednisolone for their AI versus those taking hydrocortisone.
3. 3.To compare the patterns throughout the day for low blood sugars in those taking prednisolone versus those taking hydrocortisone.

Conditions

Diabetes Mellitus, Type 1; Adrenal Insufficiency; Diabetes Mellitus Type 2 - Insulin-Treated

Outcome Measures

Primary Outcomes (1)

• Time spent in hypoglycaemia

  Percentage time spent in hypoglycaemia (glucose levels \< 3.0mmol/L, 55mg/dL). Glucose levels will be measured by a continuous glucose monitoring device (CGM).

  30 days

Secondary Outcomes (7)

• Time spent in hypoglycaemia (glucose levels < 3.9mmol/L, 70mg/dL)

  30 days

• Time spent in target glucose levels

  30 days

• Time spent in hyperglycaemia

  30 days

• Hypoglycaemic excursions

  30 days

• Gold questionnaire score

  Baseline

Study Arms (2)

Study group

Participants who live with insulin- treated diabetes and adrenal insufficiency.

Device: Continuous Glucose Monitoring

Control group

Participants who live with adrenal insufficiency and NOT with insulin-treated diabetes.

Device: Continuous Glucose Monitoring

Interventions

Continuous Glucose Monitoring DEVICE

Continuous Glucose Monitoring using a Dexcom G6 Continuous Glucose Monitoring Device

Control group; Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults living with insulin-treated diabetes and adrenal insufficiency.

You may qualify if:

• for test group:
• Confirmed diagnoses of adrenal insufficiency and insulin-treated diabetes for more than one year.
• Adults aged above 18 years
• for matched control group:
• Diabetes mellitus excluded on baseline blood review
• Adults aged above 18 years

You may not qualify if:

• Measured eGFR ≤ 30
• Acute illness
• Abnormal thyroid function
• Admission to hospital
• Pregnant or planning pregnancy
• Breastfeeding
• Enrolled in other clinical trials, except at the discretion of the chief investigator
• Have active malignancy or under investigation for malignancy
• Severe visual impairment
• Reduced manual dexterity
• Unable to participate due to other factors, as assessed by the Chief Investigators

Sponsors & Collaborators

• Imperial College Healthcare NHS Trust: lead

Study Sites (1)

Charing Cross Hospital, Imperial College Healthcare NHS Trust

London, w6 8rf, United Kingdom

Location

Related Publications (10)

• Bensing S, Brandt L, Tabaroj F, Sjoberg O, Nilsson B, Ekbom A, Blomqvist P, Kampe O. Increased death risk and altered cancer incidence pattern in patients with isolated or combined autoimmune primary adrenocortical insufficiency. Clin Endocrinol (Oxf). 2008 Nov;69(5):697-704. doi: 10.1111/j.1365-2265.2008.03340.x. Epub 2008 Aug 22.

  PMID: 18727712 BACKGROUND

• Bergthorsdottir R, Leonsson-Zachrisson M, Oden A, Johannsson G. Premature mortality in patients with Addison's disease: a population-based study. J Clin Endocrinol Metab. 2006 Dec;91(12):4849-53. doi: 10.1210/jc.2006-0076. Epub 2006 Sep 12.

  PMID: 16968806 BACKGROUND

• Chantzichristos D, Persson A, Eliasson B, Miftaraj M, Franzen S, Bergthorsdottir R, Gudbjornsdottir S, Svensson AM, Johannsson G. Mortality in patients with diabetes mellitus and Addison's disease: a nationwide, matched, observational cohort study. Eur J Endocrinol. 2017 Jan;176(1):31-39. doi: 10.1530/EJE-16-0657.

  PMID: 27928991 BACKGROUND

• Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharmaceutical Statistics. 2005;4(4):287-291. doi:https://doi.org/10.1002/pst.185

  BACKGROUND

• Lu CL, Shen HN, Hu SC, Wang JD, Li CY. A Population-Based Study of All-Cause Mortality and Cardiovascular Disease in Association With Prior History of Hypoglycemia Among Patients With Type 1 Diabetes. Diabetes Care. 2016 Sep;39(9):1571-8. doi: 10.2337/dc15-2418. Epub 2016 Jul 6.

  PMID: 27385329 BACKGROUND

• Ngaosuwan K, Johnston DG, Godsland IF, Cox J, Majeed A, Quint JK, Oliver N, Robinson S. Cardiovascular Disease in Patients With Primary and Secondary Adrenal Insufficiency and the Role of Comorbidities. J Clin Endocrinol Metab. 2021 Apr 23;106(5):1284-1293. doi: 10.1210/clinem/dgab063.

  PMID: 33585930 BACKGROUND

• Ngaosuwan K, Johnston DG, Godsland IF, Cox J, Majeed A, Quint JK, Oliver N, Robinson S. Increased Mortality Risk in Patients With Primary and Secondary Adrenal Insufficiency. J Clin Endocrinol Metab. 2021 Jun 16;106(7):e2759-e2768. doi: 10.1210/clinem/dgab096.

  PMID: 33596308 BACKGROUND

• Ngaosuwan K, Johnston DG, Godsland IF, Cox J, Majeed A, Quint JK, Oliver N, Robinson S. Mortality Risk in Patients With Adrenal Insufficiency Using Prednisolone or Hydrocortisone: A Retrospective Cohort Study. J Clin Endocrinol Metab. 2021 Jul 13;106(8):2242-2251. doi: 10.1210/clinem/dgab347.

  PMID: 33993277 BACKGROUND

• Rao Kondapally Seshasai S, Kaptoge S, Thompson A, Di Angelantonio E, Gao P, Sarwar N, Whincup PH, Mukamal KJ, Gillum RF, Holme I, Njolstad I, Fletcher A, Nilsson P, Lewington S, Collins R, Gudnason V, Thompson SG, Sattar N, Selvin E, Hu FB, Danesh J; Emerging Risk Factors Collaboration. Diabetes mellitus, fasting glucose, and risk of cause-specific death. N Engl J Med. 2011 Mar 3;364(9):829-841. doi: 10.1056/NEJMoa1008862.

  PMID: 21366474 BACKGROUND

• Emerging Risk Factors Collaboration; Sarwar N, Gao P, Seshasai SR, Gobin R, Kaptoge S, Di Angelantonio E, Ingelsson E, Lawlor DA, Selvin E, Stampfer M, Stehouwer CD, Lewington S, Pennells L, Thompson A, Sattar N, White IR, Ray KK, Danesh J. Diabetes mellitus, fasting blood glucose concentration, and risk of vascular disease: a collaborative meta-analysis of 102 prospective studies. Lancet. 2010 Jun 26;375(9733):2215-22. doi: 10.1016/S0140-6736(10)60484-9.

  PMID: 20609967 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Adrenal Insufficiency

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Adrenal Gland Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: April 10, 2023
• Study Start: April 17, 2023
• Primary Completion: August 31, 2023
• Study Completion: September 15, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)