A Randomized Clinical Trial Assessing Continuous Glucose Monitoring (CGM) Use With Standardized Education With or Without a Family Behavioral Intervention Compared With Fingerstick Blood Glucose Monitoring in Very Young Children With Type 1 Diabetes

Abstract

OBJECTIVE This study evaluated the effects of continuous glucose monitoring (CGM) combined with family behavioral intervention (CGM+FBI) and CGM alone (Standard-CGM) on glycemic outcomes and parental quality of life compared with blood glucose monitoring (BGM) in children ages 2 to <8 years with type 1 diabetes. RESEARCH DESIGN AND METHODS This was a multicenter (N = 14), 6-month, randomized controlled trial including 143 youth 2 to <8 years of age with type 1 diabetes. Primary analysis included treatment group comparisons of percent time in range (TIR) (70–180 mg/dL) across follow-up visits. RESULTS Approximately 90% of participants in the CGM groups used CGM ≥6 days/week at 6 months. Between-group TIR comparisons showed no significant changes: CGM+FBI vs. BGM 3.2% (95% CI −0.5, 7.0), Standard-CGM vs. BGM 0.5% (−2.6 to 3.6), CGM+FBI vs. Standard-CGM 2.7% (−0.6, 6.1). Mean time with glucose level <70 mg/dL was reduced from baseline to follow-up in the CGM+FBI (from 5.2% to 2.6%) and Standard-CGM (5.8% to 2.5%) groups, compared with 5.4% to 5.8% with BGM (CGM+FBI vs. BGM, P < 0.001, and Standard-CGM vs. BGM, P < 0.001). No severe hypoglycemic events occurred in the CGM+FBI group, one occurred in the Standard-CGM group, and five occurred in the BGM group. CGM+FBI parents reported greater reductions in diabetes burden and fear of hypoglycemia compared with Standard-CGM (P = 0.008 and 0.04) and BGM (P = 0.02 and 0.002). CONCLUSIONS CGM used consistently over a 6-month period in young children with type 1 diabetes did not improve TIR but did significantly reduce time in hypoglycemia. The FBI benefited parental well-being.

Continuous glucose monitoring use and glucose variability in very young children with type 1 diabetes (VibRate): A multinational prospective observational real‐world cohort study

“…More recently, a large multicentre RCT compared CGM with BGM in a cohort of 143 children with T1D aged 2‐8 years over 6 months. 17 While there was no significant difference in TIR or HbA1c, the CV improved and TBR was reduced with CGM use, both key findings consistent with the present analysis.…”

Non‐adjunctive continuous glucose monitoring for control of hypoglycaemia (COACH): Results of a post‐approval observational study

“…Numerous well‐designed studies have demonstrated that RT‐CGM use reduces frequency and duration of CGM‐measured hypoglycaemia, independent of non‐adjunctive or adjunctive labelling. 14 , 15 , 16 , 17 , 18 , 19 , 20 , 23 , 24 , 25 Although some studies have shown that RT‐CGM use also reduces severe hypoglycaemic events, 16 , 17 , 18 , 19 , 21 none were powered accordingly and some had narrow inclusion criteria (adults with T1D with history of severe hypoglycaemia or impaired awareness of hypoglycaemia), 16 , 21 limiting generalizability of results. In addition, diabetes management may have been prescriptive and participants and clinicians may have had structured RT‐CGM training.…”

Young Children with Type 1 Diabetes: Recent Advances in Behavioral Research

“…Behavioral interventions that show promise for both child and parent psychosocial functioning, as well as child glycemic outcomes, have been largely elusive to date. However, we remain optimistic that the behavioral strategies and related positive outcomes demonstrated thus far (i.e., improvements in parent distress, hypoglycemia fear, child well-being, and glycemic outcomes [ 34 , 69 ••, 70 , 71 ••]) could be incorporated into routine clinical care. Additionally, increasing social support appears to be a key mechanism to promote parent and child psychosocial functioning.…”

“…The majority of interventions have targeted caregivers of young children with T1D (see Table 1 for an overview of representative interventions). Existing interventions for parents of young children target skills for reducing hypoglycemia distress [ 69 ••], healthy eating and physical activity promotion [ 34 ], managing diabetes challenges [ 70 ], and optimizing CGM use [ 71 ••]. Through these interventions, several benefits for parents have been achieved including reduced hypoglycemia fear [ 69 ••], decreased stress [ 69 ••, 70 ] and diabetes burden [ 71 ••], and improved social support [ 72 ], quality of life [ 70 , 72 ], and well-being [ 71 ••].…”

“…Existing interventions for parents of young children target skills for reducing hypoglycemia distress [ 69 ••], healthy eating and physical activity promotion [ 34 ], managing diabetes challenges [ 70 ], and optimizing CGM use [ 71 ••]. Through these interventions, several benefits for parents have been achieved including reduced hypoglycemia fear [ 69 ••], decreased stress [ 69 ••, 70 ] and diabetes burden [ 71 ••], and improved social support [ 72 ], quality of life [ 70 , 72 ], and well-being [ 71 ••]. Young children also benefited from these interventions as evidenced by improvements in glycemic levels [ 32 ••, 34 , 70 ].…”