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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03864991
Other study ID # 5363-CHS-ERC-18
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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