Clinical efficacy of Professional Continuous Glucose Monitoring in improving glycemic control among children with Type 1 Diabetes Mellitus: An Open-label Randomized Control Trial

K V Raviteja,Naresh Sachdeva,Devi Dayal,Rakesh Kumar

doi:10.1038/s41598-019-42555-6

Abstract

Frequent self-monitoring of blood glucose (SMBG) is the only accurate method available for insulin dose titration in patients with T1DM. Professional continuous glucose monitoring (p-CGM) is blinded recording of glucose trends over 5–7 days and helps physicians to guide insulin titration to patient. This study was planned to assess efficacy of insulin dose adjustments, based on p-CGM plus SMBG in improving glycemic control compared to SMBG alone. We did an open-label, parallel design, randomized control trial among children (2–10 years) having T1DM for at least 6 months. Subjects in the intervention group were placed on p-CGM (iPRO 2™ Professional CGM, Medtronic, USA) for 3–5 days along with regular SMBG. Data from p-CGM was analyzed by physician and used to guide insulin titration along with SMBG over following 3 months. Control group had only SMBG records for titrating insulin doses. Primary outcome was change in HbA1c 3 months after intervention. A total of 68 eligible children were randomized, 34 each to either arms. Thirty children in intervention group and 33 in control group completed the study and were analyzed. It was found that there was more decreased unit change in HbA1c, percentage of low sugar records and total insulin requirement per day, after 3 months follow-up, in intervention group. However, difference was not significant except for total insulin Units/kg/day (p = 0.014). In sub-group analysis of children with baseline HbA1c >7.5%, there was a significant mean fall of HbA1c by 1.27% (p = 0.045). There were no major adverse events associated with p-CGM. We conclude that addition of p-CGM along with SMBG may help in adjusting insulin dose more effectively especially in children with higher baseline HbA1c.

Highlights

Multiple daily insulin injections (MDI) with frequent self-monitoring of blood glucose (SMBG) has been a standard of care in the management of Type 1 DM following results of the Diabetes Control and Complications Trial (DCCT)[1,2]
With the use of Professional continuous glucose monitoring (p-CGM), it has become more apparent that conventional SMBG does not provide real trends of blood glucose levels and continuously recorded glucose data by p-CGM gives a better picture of glucose trends and can help guiding insulin doses more accurately
Only a few studies have been conducted to assess the efficacy of p-CGM in T1DM among pediatric population especially below 7 years of age

Summary

Introduction

Multiple daily insulin injections (MDI) with frequent self-monitoring of blood glucose (SMBG) has been a standard of care in the management of Type 1 DM following results of the Diabetes Control and Complications Trial (DCCT)[1,2]. It is difficult to achieve optimal glycemic control, despite intensive insulin therapy and frequent self-monitoring of blood glucose. To address these problems of SMBG, efforts have been made to develop accurate and feasible continuous glucose monitoring systems (p-CGM). With the use of p-CGM, it has become more apparent that conventional SMBG does not provide real trends of blood glucose levels and continuously recorded glucose data by p-CGM gives a better picture of glucose trends and can help guiding insulin doses more accurately. We planned this study to assess the efficacy of insulin dose adjustments in improving glycemic control among children with T1DM, based on glucose data from combined p-CGM and SMBG when compared to SMBG alone

Methods

Results

Conclusion