Relationship Between HbA1c Level, Sleep Quality and Sleep Duration

November 2, 2020 updated by: Terun Desai, University of Hertfordshire

The Relationship Between the Elevation of Haemoglobin A1c Level, Sleep Quality and Sleep Duration in Clinically Diagnosed Pre-diabetic Patients in a Nationally Representative Sample

The study will be conducted during the period of, January 2019 - August 2019 with pre-diabetic participants on a NHS England funded National Diabetes Prevention Program (NDPP) with a clinically diagnosed Haemoglobin A1c (HbA1c) referral reading of between 42mmol/mol - 47mmol/mol within the last 12 months. The term pre-diabetic can all be used to explain blood glucose levels that are higher than normal, but not high enough for participants to be diagnosed with Type 2 diabetes. Having high blood glucose levels can increase a participant's risk of developing Type 2 diabetes and other health complications, although this is not inevitable.

100 participants will take part in the study. Participants will be eligible if they are aged between 18 and 65 years and have an HbA1c referral reading of between 42-47mmol/mol within the last 12 months.

The participants will be given a written consent form to sign to take part in the study, after receiving both written and verbal information beforehand on the study protocol from the researcher. Health screening to determine eligibility for the NHS funded program will be undertaken directly by the intervention provider.

Study design and procedures:

The study will be delivered in a controlled format and will be designed to assess the relationship between the elevation of HbA1c level, sleep quality and sleep duration in clinically diagnosed pre-diabetic participants referred and registered to join the NHS NDPP. Participants will receive a pre-program information pack in conjunction with a sleep quality and sleep duration questionnaire at the end of their 1:1 initial appointments for the NHS NDPP.

Participants will be given prepaid envelopes to send their anonymised questionnaires back to the researcher once completed after their appointments. The researcher will ensure confidentiality by keeping all questionnaires in a securely combination coded locked cupboard that only the researcher has access to. Participants will be instructed to not write their names on the questionnaires but to only state their gender, age, and referral HbA1c reading received from the relevant health care professional.

Study Overview

Study Type

Observational

Enrollment (Actual)

100

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

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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Aged 18 years - 65 years with pre-diabetes (diagnosed as HbA1c referral reading of between 42-47mmol/mol within the last 12 months)

Description

Inclusion Criteria:

  • Participants were eligible if they were aged 18 years - 65 years
  • Had an HbA1c referral reading of between 42-47mmol/mol within the last 12 months
  • Registered on the NHSE NDPP

Exclusion Criteria:

  • Participants with a severe debilitating disease which may have interfered with the study participation
  • Under the age of 18 years or over the age of 65 years
  • Pregnant

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep Quality
Time Frame: 1 month

Sleep quality was measured from PSQI.

Scoring system:

Not during the past month = 0 Less than once a week = 1 Once or twice a week = 2 Three or more times a week = 3

1 month
Sleep Duration
Time Frame: 1 month

Sleep duration was measured from PQSI.

Scoring system:

Not during the past month = 0 Less than once a week = 1 Once or twice a week = 2 Three or more times a week = 3

1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: Within 12 months
Retrieved from NHS referral database
Within 12 months

Collaborators and Investigators

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

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)

January 8, 2019

Primary Completion (Actual)

September 6, 2019

Study Completion (Actual)

September 6, 2019

Study Registration Dates

First Submitted

July 23, 2019

First Submitted That Met QC Criteria

July 23, 2019

First Posted (Actual)

July 25, 2019

Study Record Updates

Last Update Posted (Actual)

November 3, 2020

Last Update Submitted That Met QC Criteria

November 2, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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