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

NCT05806190 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 32

Last updated 2023-09-28

No results posted yet for this study

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. 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. To compare how often low blood sugars occur in people taking prednisolone for their AI versus those taking hydrocortisone.
3. To compare the patterns throughout the day for low blood sugars in those taking prednisolone versus those taking hydrocortisone.

The study will compare this information with results in people who have AI without diabetes.

Participants will be given continuous glucose monitoring systems (Dexcom G6 devices) which are small wearable devices that measure glucose levels throughout the day and night. They will be asked to wear a device for 30 days. Participants will not be asked to make any changes to their usual medications or their diet.

Conditions

Interventions

DEVICE

Continuous Glucose Monitoring

Continuous Glucose Monitoring using a Dexcom G6 Continuous Glucose Monitoring Device

Sponsors & Collaborators

  • Imperial College Healthcare NHS Trust

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-17
Primary Completion
2023-08-31
Completion
2023-09-15
FDA Device
Yes

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05806190 on ClinicalTrials.gov