Lifestyle Changes and Glycemic Control in T1D

Life Style Clinical Trial

— LSHBA1C  

Official title:

Lifestyle Changes and Glycemic Control in Type 1 Diabetes Mellitus: A Factorial Design Approach

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03864991
• Other study ID #: 5363-CHS-ERC-18
• Status: Recruiting
• Phase: N/A
• Start date: October 29, 2018
• Est. completion date: May 31, 2020

Study information

• Verified date: March 2019
• Source: Aga Khan University
• Contact: Amna R Siddiqui, Phd
• Phone: 00922134864818
• Email: rehana.siddiqui[@]aku.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pakistani studies report non-adherence to self-management by type 1 diabetes (T1D) patients, and episodes of hypoglycemia and ketoacidosis as acute complications. Self-management guidelines include maintenance of logbooks for blood glucose, physical activity, and dietary intake, that affect glycated hemoglobin (HbA1C) and acute complications. The proposed study will evaluate whether mobile messaging for maintaining log books for blood glucose or e-device use for step count will modify HbA1c levels to be examined at three and six months after enrollment. In addition, episodes of acute complications and blood glucose variability will be correlated with daily log book maintenance and step counts.

Description:

Type 1 diabetes (T1D) occurs due to destruction of insulin producing beta cells in pancreas. T1D usually occurs in children and young individuals, and requires continuous blood glucose monitoring for adjustment of insulin dosage on a daily basis. Incidence of T1D has been increasing over the past three decades. Hyperglycemia and ketoacidosis episodes are common adverse effects due to irregular monitoring of daily blood glucose. It is a big challenge in developed as well as developing countries to live with T1D due to less optimal use of timely entry in logbook for self-monitoring of blood glucose (SMBG). Current guidelines recommend SMBG use in all patients with diabetes. According to a study, increased daily frequency of SMBG was significantly associated with lower glycated hemoglobin (HbA1C) along with added benefits of fewer acute complications among children and adolescents. Available literature from Pakistan highlights non-adherence of T1D patients to recommended dietary advice (58.5%), physical activity (42.3%) and prescribed insulin regimen (88.1%). Use of mobile applications has been shown to increase the medication adherence and use of self-blood glucose testing. Increased daily step count by T1D patients helped to reduce the risk of cardiovascular events. A wearable e-device accompanied with an application (Fitbit App) tracks step count by recording data in mobile application. HbA1C levels acts as an indicator for the glycemic control and correlates with complications. However, HbA1C cannot determine the daily variability of blood glucose, thus SMBG can help predict the average daily risk reduction in T1D complications. The proposed study will address the adherence to standard protocols for maintaining home based records by patients and caregivers and insulin therapy, optimizing the quarterly HbA1C levels.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: May 31, 2020
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• Patient diagnosed with T1D > 6 months

• Patient's age = 15 years

• Patient or any one of the family member like father, mother or sibling using smart phone.

• Patient or any one of the family member know how to use (receive calls or read text message) a smart phone.

Exclusion Criteria:

• Patient on insulin pump

• Pregnant females,

• Patient with neurodevelopmental delay or thalassemia

• Patient currently using any kind of authentic e-device for step count or physical activity.

Related Conditions & MeSH terms

• Behavioral Changes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Life Style
• Problem Behavior
• Self-Management
• Type1 Diabetes Mellitus

Intervention

Device:
• e-device for step count (fit-bit)
Patients in this group will receive fitbit device to count their daily steps and record it into their log books.

Behavioral:
• e-messages for log book
Patients in this group will receive e-messages to maintain their log books as per instruction for blood sugar levels and send back weekly through snap shot.
• e-messages for log book & fit-bit
Patient in this group will receive e-messages to maintain their log books for blood sugar levels as well as use fitbit device and maintain their log book for daily step count and send back weekly through snap shot.

Locations

Country	Name	City	State
Pakistan	Aga Khan University Hospital	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Aga Khan University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in HbA1c	Blood HbA1c levels will be measured at baseline, three and six months. It will be taken on ratio scale measured in mmol/mol	Each participant will be in the study for the period of six months
Secondary	Episodes of acute complications	Hyperglycemia >450 mg/dl or "Hi" on glucometer, Ketoacidosis per hospital diagnosed, Hypoglycemia <60 mg/dl or "low" on glucometer three times a day.	Each participant will be in the study for the period of six months