Lifestyle Changes and Glycemic Control in T1D (LSHBA1C)

March 5, 2019 updated by: Syed Iqbal Azam, Aga Khan University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

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

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan
        • Recruiting
        • Aga Khan University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Iqbal Azam, MSc
        • Sub-Investigator:
          • Rehana Siddiqui, PhD
        • Sub-Investigator:
          • Sobiya Sawani, MSc
        • Sub-Investigator:
          • Khadija Humayun
        • Sub-Investigator:
          • Asma Ahmed
        • Sub-Investigator:
          • Aysha Habid
        • Sub-Investigator:
          • Romaina Iqbal, PhD

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

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Routine Care
This group will be followed up for routine care, maintaining a standard log book for documenting blood sugar and insulin dosages per advice and explanation by doctors, nurses and nutritionists.
Active Comparator: e-device for step count (fit-bit)
This group will receive e-device for step count (fit-bit) in addition to routine care.
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.
Active Comparator: e-messages for log book
This group will receive daily e-messages for maintaining log book in addition to routine care.
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.
Active Comparator: e-messages for log book & fit-bit
This group will receive e-device for step count (fit-bit), daily e-messages for maintaining log book for blood sugar, insulin dosages and step count in addition to routine care.
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 & 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in HbA1c
Time Frame: Each participant will be in the study for the period of six months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Episodes of acute complications
Time Frame: Each participant will be in the study for the period of six months
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

Collaborators and Investigators

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

Sponsor

Aga Khan University

Investigators

  • Principal Investigator: Iqbal Azam, MSc, Aga Khan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 29, 2018

Primary Completion (Anticipated)

November 30, 2019

Study Completion (Anticipated)

May 31, 2020

Study Registration Dates

First Submitted

February 28, 2019

First Submitted That Met QC Criteria

March 5, 2019

First Posted (Actual)

March 6, 2019

Study Record Updates

Last Update Posted (Actual)

March 6, 2019

Last Update Submitted That Met QC Criteria

March 5, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5363-CHS-ERC-18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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