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临床试验/NCT03864991
NCT03864991Unknown不适用

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

Aga Khan University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2018年10月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
120
试验地点
1
主要终点
Changes in HbA1c

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Other
盲法
None

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Routine Care

No Intervention

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.

e-device for step count (fit-bit)

Active Comparator

This group will receive e-device for step count (fit-bit) in addition to routine care.

干预措施: e-device for step count (fit-bit) (Device)

e-messages for log book

Active Comparator

This group will receive daily e-messages for maintaining log book in addition to routine care.

干预措施: e-messages for log book (Behavioral)

e-messages for log book & fit-bit

Active Comparator

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.

干预措施: e-device for step count (fit-bit) (Device)

e-messages for log book & fit-bit

Active Comparator

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.

干预措施: e-messages for log book & fit-bit (Behavioral)

结局指标

主要结局

Changes in HbA1c

时间窗: 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

次要结局

  • Episodes of acute complications(Each participant will be in the study for the period of six months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Syed Iqbal Azam

Assistant Professor

Aga Khan University

研究点 (1)

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