The effect of do‐it‐yourself real‐time continuous glucose monitoring on psychological and glycemic variables in children with type 1 diabetes: A randomized crossover trial

Abstract

Background Continuous glucose monitoring (CGM) decreases fear of hypoglycemia (FOH) and improves glycemic control among those affected by type 1 diabetes (T1D). No studies to date have examined the impact of using do‐it‐yourself real‐time continuous glucose monitoring (DIY RT‐CGM) on psychological and glycemic outcomes. Methods Child–parent dyads were recruited for a multicentre randomized crossover trial. Children with T1D were current intermittently scanned CGM (isCGM) users and aged 2–13 years. Families received either 6 weeks of DIY RT‐CGM with parental remote monitoring (intervention) or 6 weeks of isCGM plus usual diabetes care (control), followed by a 4‐week washout period, then crossed over. The primary outcome was parental FOH. Secondary outcomes were glycemic control using traditional CGM metrics, as well as a range of other psychosocial measures. Findings Fifty five child–parent dyads were recruited. The child mean age was 9.1 ± 2.8 years. Although, there was no effect on parental FOH, −0.1 (95%CI: −0.3, 0.1, p = 0.4), time‐in‐range (TIR) (%3.9‐10 mmol/L) was significantly higher with DIY RT‐CGM over isCGM (54.3% ± 13.7 vs. 48.1% ± 13.6), mean difference, 5.7% (95%CI 1.8, 9.6, p <0.004). There was no difference for time spent in hypoglycemia. Parent diabetes treatment satisfaction was significantly higher following DIY RT‐CGM compared to isCGM, mean difference 5.3 (95%CI: 2.3, 8.2, p <0.001). Conclusion The use of DIY RT‐CGM versus isCGM did not improve parental FOH; however, TIR and parental satisfaction with diabetes treatment were significantly improved. This suggests in the short term, DIY RT‐CGM appears safe and may offer families some clinically important advantages over isCGM.

Utility of Technology in the Treatment of Type 1 Diabetes: Current State of the Art and Precision Evidence

“…As shown in Table 1, the literature search identified 27 articles, 15 primary analyses, [12][13][14][15][16][17][18][19][20][21][22][23][24][25][26] 4 secondary analyses, 27-30 4 extension studies, 31-34 and 4 PROs [35][36][37][38] . Of primary analyses, 13 were RCTs using parallel (n=10) or crossover (n=3) design comparing CGM to SMBG.…”

“…Of primary analyses, 13 were RCTs using parallel (n=10) or crossover (n=3) design comparing CGM to SMBG. The majority of studies investigated standalone-use of rtCGM, 13,[15][16][17][18]20,21,27,30,31,33,34 while some also examined the use of diagnostic ('professional') rtCGM, 14 do-it-yourself rtCGM, 23 standalone isCGM, 19,22,28,29 and decision support systems on top of CGM. 12,22 The number of included participants ranged from 52 to 448 with a wide age range (from children to older adults).…”

“…Three studies had a duration of more than 12 months, 27,32,37 with most studies having a maximum of 6 months of follow-up. [12][13][14][15][16][17][18][19][20][21][22][23][24][25][28][29][30][31]33,34,[36][37][38] Most RCTs (primary analysis) had HbA1c as the primary outcome, 12,16,18,20,21,24,25,32,33 with hypoglycemia as the primary outcomes in three studies 15,17,19 and TIR 13,22 in two studies. One study included the Parental Hypoglycemia Fear Survey as the primary outcome.…”

“…One study included the Parental Hypoglycemia Fear Survey as the primary outcome. 23 Reported secondary outcomes were diverse, encompassing many aspects of diabetes management and well-being (Table 1).…”

Do‐it‐yourself continuous glucose monitoring in people aged 16 to 69 years with type 1 diabetes: A qualitative study

“…In response, DIY-CGM is a solution that has evolved from the #WeAreNotWaiting movement. A third-party device (MiaoMiao, MM version 2, Smart Reader, AWX Bio Co. Ltd.) is available 4,12,13 and provides many of the benefits of commercial rt-CGM at a reduced price of US$149.00 per device (which is reusable). [12][13][14] The device uses Bluetooth to transmit data from a first-generation isCGM sensor to a paired smart device such as a phone or smartwatch (Figure 1).…”