Ignite Creation Date:
2025-12-24 @ 12:34 PM
Ignite Modification Date:
2026-01-29 @ 12:50 AM
Study NCT ID:
NCT04032561
Status:
COMPLETED
Last Update Posted:
2020-11-03
First Post:
2019-07-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relationship Between HbA1c Level, Sleep Quality and Sleep Duration
Sponsor:
University of Hertfordshire
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: