Abstract
BackgroundType 1 diabetes (T1D) has been increasing globally over the past three decades. Self-monitoring of blood glucose is a challenge in both developed as well as developing countries. Self-management guidelines include maintaining logbooks for blood glucose, physical activity, and dietary intake that affect glycated hemoglobin (HbA1c) and a multitude of life-threatening acute complications. Innovative, cost-effective interventions along with beneficial lifestyle modifications can improve home-based self-monitoring of blood glucose in T1D patients. The overall objective of this study is to evaluate the relationship between maintaining log books for blood glucose levels, reinforcement by e-messages, and/or daily step count and changes in HbA1c.Methods/designA randomized controlled trial will enroll participants aged 15 years and above in four groups. Each group of 30 participants will be working with a newly designed standard log book for documenting their blood glucose. The first group will be entirely on routine clinical care, the second group will be on routine care and will receive an additional e-device for recording step count (fit bit), the third group will receive routine care and daily motivational e-messages to maintain the log book, and the fourth group along with routine care will receive an e-device for measuring step count (fit bit) and e-messages about maintaining the log book. Patients will be enrolled from pediatric and endocrine clinics of a tertiary care hospital in Karachi. All groups will be followed up for a period of 6 months to evaluate outcomes. Log book data will be obtained every 3 months electronically or during a patient’s clinic visit. HbA1c as a main outcome will be measured at baseline and will be evaluated twice every 3 months. A baseline questionnaire will determine the socio-demographic, nutritional, and physical activity profile of patients. Clinical information for T1D and other co-morbidities for age of onset, duration, complications, hospitalizations, habits for managing T1D, and other lifestyle characteristics will be ascertained. Behavioral modifications for maintaining daily log books as a routine, following e-messages alone, fit bit alone, or e-messages plus using fit bit will be assessed for changes in HbA1c using a generalized estimated equation.DiscussionThe proposed interventions will help identify whether maintaining log books for blood glucose, motivational e-messages, and/or daily step count will reduce HbA1c levels.Trial registrationClinicalTrials.gov, NCT03864991. March 6, 2019.
Highlights
Type 1 diabetes (T1D) has been increasing globally over the past three decades
The proposed interventions will help identify whether maintaining log books for blood glucose, motivational e-messages, and/or daily step count will reduce Glycated hemoglobin (HbA1c) levels
self-monitoring of blood glucose (SMBG) is an invaluable method for monitoring glycemic status; current guidelines recommend its use in all patients with T1D, type 2 diabetes mellitus (T2DM), or any other forms of diabetes that require administering multiple subcutaneous insulin injections [5]
Summary
Type 1diabetes (T1D) is an autoimmune disease in which insulin-producing beta cells in the pancreas are destroyed by the human body pathologically, preventing the body from being able to produce enough insulin to adequately regulate blood glucose levels. T1D occurs mostly in the pediatric and adolescent age groups with patients presenting with a hyperglycemia and/or diabetic ketoacidosis episode Such episodes are the most common life-threatening adverse effects following diagnosis resulting from suboptimal treatment if insulin dosage is not adjusted and blood glucose is not monitored on a daily basis. This study proposes to study maintenance of log books for blood glucose levels and whether motivational e-messages and/or using an edevice for measuring step count, alone or together, can potentially help reduce HbA1c levels in T1D patients. The proposed study will record adherence to standard protocols for maintenance of SMBG records by patients, checking HbA1c level every three months, and maintaining an insulin dosage record on a daily basis to determine if these lead to reduction in acute complications in T1D patients, thereby reducing their illness-associated mortality and morbidity. To compare the variability of daily blood glucose measurements using an average daily risk range method
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