Lifestyle Changes and Glycemic Control in T1D

Not Applicable

• Conditions: Self-Management; Type1 Diabetes Mellitus; Life Style; Behavioral Changes
• Interventions: Device: e-device for step count (fit-bit); Behavioral: e-messages for log book; Behavioral: e-messages for log book & fit-bit

• Registration Number: NCT03864991
• Lead Sponsor: Aga Khan University

Brief 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.

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 Timeline

• Study Start: 2018-10-29
• Study First Submitted: 2019-02-28
• Status Verified: 2019-03
• Study First Submitted QC: 2019-03-05
• Last Update Submitted: 2019-03-05
• Study First Posted: 2019-03-06
• Last Update Posted: 2019-03-06
• Primary Completion: 2019-11-30
• Study Completion: 2020-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
e-device for step count (fit-bit)	e-device for step count (fit-bit)	This group will receive e-device for step count (fit-bit) in addition to routine care.
e-messages for log book	e-messages for log book	This group will receive daily e-messages for maintaining log book in addition to routine care.
e-messages for log book & fit-bit	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.
e-messages for log book & fit-bit	e-device for step count (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.

Primary Outcome Measures

Name	Time	Method
Changes in HbA1c	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

Secondary Outcome Measures

Name	Time	Method
Episodes of acute complications	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.

Trial Locations

Locations (1)

Aga Khan University Hospital; 🇵🇰 Karachi, Sindh, Pakistan