| CTRI Number |
CTRI/2025/07/091667 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
19/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
"A Study to Understand How Sleep Quality Affects Blood Sugar Control in People with Type 2 Diabetes" |
|
Scientific Title of Study
|
Exploring the Relationship between Sleep Quality and Glycemic Control in Patients
with Type 2 Diabetes Mellitus Using Actigraphy: A Prospective Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ayesha Juhi |
| Designation |
Associate Professor |
| Affiliation |
All India Institute Of Medical Sciences, Deoghar |
| Address |
Academic Building, Department of Physiology, AIIMS Deoghar campus, Devipur
Deoghar
JHARKHAND
814152
India |
| Phone |
8008770156 |
| Fax |
|
| Email |
juhiayesha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ayesha Juhi |
| Designation |
Associate Professor |
| Affiliation |
All India Institute Of Medical Sciences, Deoghar |
| Address |
Academic Building, Department of Physiology, AIIMS Deoghar campus, Devipur
Deoghar
JHARKHAND
814152
India |
| Phone |
8008770156 |
| Fax |
|
| Email |
juhiayesha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ayesha Juhi |
| Designation |
Associate Professor |
| Affiliation |
All India Institute Of Medical Sciences, Deoghar |
| Address |
Academic Building, Department of Physiology, AIIMS Deoghar campus, Devipur
Deoghar
JHARKHAND
814152
India |
| Phone |
8008770156 |
| Fax |
|
| Email |
juhiayesha@gmail.com |
|
|
Source of Monetary or Material Support
|
| CSIR,HRDG Extramural Project |
|
|
Primary Sponsor
|
| Name |
Council for Scientific and Industrial research, HRDG |
| Address |
CSIR Complex, Library Avenue, Pusa New Delhi 110 012 India |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| AYESHA JUHI |
All India Institute of Medical Sciences, Deoghar |
Room no. 1, Research lab, Department of Physiology, 4th floor, Academic Building
Deoghar
JHARKHAND |
08008770156
ayesha.physiology@aiimsdeoghar.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Deoghar, Institutional Ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1.Adults aged 18 years to 65 years who have been diagnosed with Type 2 diabetes mellitus
with a minimum of 6 months duration.
2.Patients who are able to provide informed consent and participate in the study
voluntarily.
3.Patients who have been undergoing treatment for Type 2 diabetes mellitus for at least six
months.
4.Patients who are willing to undergo regular blood tests to monitor their HbA1c levels
and other relevant biomarkers.
5.Patients who are willing to wear sleep monitoring devices to assess their sleep quality.
6.Patients who are able to attend regular follow up visits as part of the study protocol.
|
|
| ExclusionCriteria |
| Details |
1.Patients who have a history of sleep disorders other than poor sleep quality, such as
sleep apnea or narcolepsy.
2.Patients who have a history of psychiatric disorders that may affect sleep quality or
glycemic control, such as major depression or anxiety disorders.
3.Patients who have a history of substance abuse or dependence, including alcohol,
opioids, or other drugs
4.Patients who are currently undergoing treatment with medications that may affect
sleep quality or glycemic control, such as corticosteroids or beta-blockers.
5.Patients who have any significant medical conditions other than diabetes mellitus,
such as cancer or chronic kidney disease, that may affect sleep quality or glycemic
control.
6.Patients who are unable to comply with the study protocol or attend regular follow-up
visits. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To explore the relationship between sleep quality (measured with Actigraphy) and glycemic control (measured in terms of glycated haemoglobin) in patients with type 2 diabetes mellitus |
Baseline, after 1 week and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify any factors that may confound or modify the relationship between sleep quality & glycemic control, such as age, gender, & body mass index (BMI), & body fat% |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aim of the project is to investigate the potential relationship between sleep quality, as measured by actigraphy, and level glycemic control in patients with type 2 diabetes mellitus. This project seeks to provide a better understanding of the potential impact of sleep quality on glycemic control in individuals with diabetes, which may help clinicians develop more effective management strategies. Glycemic control refers to the ability of individuals with diabetes to regulate their blood sugar levels, which is crucial for preventing complications associated with the condition. Poor sleep quality has been linked to various health issues, including metabolic disorders like diabetes. By using Actigraphy to measure sleep quality, the study can provide objective and accurate data on participants’ sleep patterns, which may be more reliable than self-reported data. Additionally, this study’s prospective design allows for the observation of changes in sleep quality and glycemic control over time, providing a more comprehensive understanding of the relationship between these variables. Actigraphy is a non-invasive method of measuring sleep. Patients do not need to attach electrodes to their scalp, which is required for methods such as polysomnography. Patients can wear the device on their wrist, and it does not require any supervision during sleep, making it suitable for long-term monitoring of sleep quality. Actigraphy is relatively inexpensive compared to other methods such as polysomnography, which requires expensive equipment and trained technicians to monitor the patient during sleep. Hence, we aimed to objectively measure sleep quality and duration by Actigraphy for objectively assess the sleep quality and find its possible association with glycemic control in patients suffering from type 2 diabetes mellitus. The study objective is to explore the relationship between sleep quality (measured with Actigraphy) and glycemic control (measured in terms of glycated haemoglobin) in patients with type 2 diabetes mellitus and also to identify any factors that may confound or modify the relationship between sleep quality and glycemic control, such as age, gender, and body mass index (BMI), and body fat percentage. |