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

September 27, 2023 updated by: Imperial College Healthcare NHS Trust

Frequency of Nocturnal Hypoglycaemia in Adults With Insulin-treated Diabetes and Adrenal Failure Using Prednisolone or Hydrocortisone: a Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PURPOSE OF THE STUDY

The purpose of this study is to measure how often hypoglycaemia occurs in people who take steroid tablets for adrenal insufficiency and insulin for diabetes compared to individuals with adrenal insufficiency on steroid tablets without diabetes. To do this, participants will be given a continuous glucose monitoring (CGM) system, which is an effective and accurate way of measuring blood sugars throughout the day and night. This study will assess how often hypoglycaemia occurs, especially at night, and whether the type of steroid tablet people take affects how often hypoglycaemia happens.

STUDY AIMS

  1. To measure how often low blood sugars occur at night in people with both AI and insulin-treated diabetes using CGM, and in people without diabetes who are matched in age, sex and steroid replacement (hydrocortisone or prednisolone).
  2. To compare the frequency of low blood sugars 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.

STUDY DESIGN

This study will observe 16 adults with both insulin-treated diabetes and adrenal insufficiency and 16 adults without diabetes who are matched for age, sex and steroid replacement. The investigators will aim to recruit 32 participants in total. Participants will spend 30 days in the study.

RECRUITMENT Recruitment will be undertaken in endocrinology and diabetes clinics at Imperial College Healthcare NHS Trust. Participant information sheets will be given to potential participants and following any questions, informed consent will be taken.

Participants will be given as much time as they require (at least 24 hours) to decide whether or not to take part - this can vary on a per participant basis.

Study Type

Observational

Enrollment (Actual)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, W6 8RF
        • Charing Cross Hospital, Imperial College Healthcare NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults living with insulin-treated diabetes and adrenal insufficiency.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study group
Participants who live with insulin- treated diabetes and adrenal insufficiency.
Device: Continuous Glucose Monitoring
Continuous Glucose Monitoring using a Dexcom G6 Continuous Glucose Monitoring Device
Control group
Participants who live with adrenal insufficiency and NOT with insulin-treated diabetes.
Device: Continuous Glucose Monitoring
Continuous Glucose Monitoring using a Dexcom G6 Continuous Glucose Monitoring Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time spent in hypoglycaemia
Time Frame: 30 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time spent in hypoglycaemia (glucose levels < 3.9mmol/L, 70mg/dL)
Time Frame: 30 days
Percentage time spent in hypoglycaemia (glucose levels < 3.9mmol/L, 70mg/dL)
30 days
Time spent in target glucose levels
Time Frame: 30 days
Percentage time spent in target (glucose levels 3.9-10mmol/L, 70-180mg/dL)
30 days
Time spent in hyperglycaemia
Time Frame: 30 days
Percentage time spent in hyperglycaemia (glucose levels >10mmol/L, 180mg/dL)
30 days
Hypoglycaemic excursions
Time Frame: 30 days
Number of hyperglycaemic excursions. This will comprise the number of times glucose sugar levels are recorded as below 3.9mmol/L, 70mg/dL
30 days
Gold questionnaire score
Time Frame: Baseline
The Gold questionnaire asks individuals to report their experience in detecting hypoglycemic events with scores ranging from minimum score of 1 (always aware) to a maximum score of 7 (never aware). The minimum score refers to the individual never being aware of hypoglycaemia, and an increasing score refers to greater awareness of hypoglycaemia.
Baseline
Hypoglycaemia Fear Survey-II (HFS-II) score
Time Frame: Baseline
This 33-item questionnaire assesses fear of hypoglycaemia. The minimum score is 0 and the maximum score is 132. A higher score indicated greater fear of hypoglycaemia.
Baseline
Hospital Anxiety and Depression (HADS) Score
Time Frame: Baseline
A questionnaire assessing levels of anxiety and depression. The questionnaire consists of 14 questions: 7 questions assess for anxiety and 7 questions assess for depression. Each question can score between 0 and 3. Two scores are calculated separately for anxiety and depression. The minimum score is 0 and maximum score is 21 for both anxiety and depression. A greater score denotes greater severity of anxiety or depression.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College Healthcare NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2023

Primary Completion (Actual)

August 31, 2023

Study Completion (Actual)

September 15, 2023

Study Registration Dates

First Submitted

March 28, 2023

First Submitted That Met QC Criteria

April 7, 2023

First Posted (Actual)

April 10, 2023

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 27, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22SM8022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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