Aim
Managing type 1 diabetes in young children can cause significant stress for parents. Continuous glucose monitoring (CGM) may reduce parental burden. The Strategies to Enhance CGM Use in Early ...Childhood (SENCE) trial randomized parents of children (ages 2 to <8 years) with type 1 diabetes to CGM with family behavioural intervention (CGM + FBI), CGM alone (Standard‐CGM) or blood glucose monitoring for 26 weeks before receiving CGM + FBI (BGM‐Crossover). This report assesses changes in psychosocial outcomes for all groups over 52 weeks.
Methods
CGM + FBI (n = 45), Standard‐CGM (n = 42) and BGM‐Crossover (n = 44) participants completed psychosocial assessments at baseline, 26 weeks and 52 weeks. Repeated measures linear regression models evaluated change within and between treatment groups.
Results
The BGM‐Crossover group reported improved diabetes burden (Δ −6.9, 95% CI −11.3, −2.6, p = 0.003), fear of hypoglycaemia (Δ −6.4, CI −10.1, −2.6, p = 0.002) and technology satisfaction (Δ 7.3, CI 2.4, 12.2, p = 0.005) from 26 to 52 weeks, similar to published findings in the CGM + FBI group over the first 26 weeks. The Standard‐CGM group reported increased technology satisfaction (Δ 7.3, CI 0.6, 14.0, p = 0.027) from baseline to 52 weeks. The CGM + FBI group reported less diabetes burden and fear of hypoglycaemia from baseline to 52 weeks, but changes were not statistically significant. Scores from 26 to 52 weeks did not deteriorate.
Conclusions
Parents demonstrated psychosocial benefits following FBI that appeared to maintain without additional intervention. CGM‐focused education with behavioural support likely helps parents of young children with type 1 diabetes reduce burden and worry in the short‐ and long‐term.
Assess the efficacy of inControl AP, a mobile closed-loop control (CLC) system.
This protocol, NCT02985866, is a 3-month parallel-group, multicenter, randomized unblinded trial designed to compare ...mobile CLC with sensor-augmented pump (SAP) therapy. Eligibility criteria were type 1 diabetes for at least 1 year, use of insulin pumps for at least 6 months, age ≥14 years, and baseline HbA
<10.5% (91 mmol/mol). The study was designed to assess two coprimary outcomes: superiority of CLC over SAP in continuous glucose monitor (CGM)-measured time below 3.9 mmol/L and noninferiority in CGM-measured time above 10 mmol/L.
Between November 2017 and May 2018, 127 participants were randomly assigned 1:1 to CLC (
= 65) versus SAP (
= 62); 125 participants completed the study. CGM time below 3.9 mmol/L was 5.0% at baseline and 2.4% during follow-up in the CLC group vs. 4.7% and 4.0%, respectively, in the SAP group (mean difference -1.7% 95% CI -2.4, -1.0;
< 0.0001 for superiority). CGM time above 10 mmol/L was 40% at baseline and 34% during follow-up in the CLC group vs. 43% and 39%, respectively, in the SAP group (mean difference -3.0% 95% CI -6.1, 0.1;
< 0.0001 for noninferiority). One severe hypoglycemic event occurred in the CLC group, which was unrelated to the study device.
In meeting its coprimary end points, superiority of CLC over SAP in CGM-measured time below 3.9 mmol/L and noninferiority in CGM-measured time above 10 mmol/L, the study has demonstrated that mobile CLC is feasible and could offer certain usability advantages over embedded systems, provided the connectivity between system components is stable.
Abstract
The significant and growing global prevalence of diabetes continues to challenge people with diabetes (PwD), healthcare providers, and payers. While maintaining near-normal glucose levels ...has been shown to prevent or delay the progression of the long-term complications of diabetes, a significant proportion of PwD are not attaining their glycemic goals. During the past 6 years, we have seen tremendous advances in automated insulin delivery (AID) technologies. Numerous randomized controlled trials and real-world studies have shown that the use of AID systems is safe and effective in helping PwD achieve their long-term glycemic goals while reducing hypoglycemia risk. Thus, AID systems have recently become an integral part of diabetes management. However, recommendations for using AID systems in clinical settings have been lacking. Such guided recommendations are critical for AID success and acceptance. All clinicians working with PwD need to become familiar with the available systems in order to eliminate disparities in diabetes quality of care. This report provides much-needed guidance for clinicians who are interested in utilizing AIDs and presents a comprehensive listing of the evidence payers should consider when determining eligibility criteria for AID insurance coverage.
Graphical Abstract
Advances in diabetes technology have transformed the treatment paradigm for type 1 diabetes, yet the burden of disease is significant. We report on a pivotal safety study of the first tubeless, ...on-body automated insulin delivery system with customizable glycemic targets.
This single-arm, multicenter, prospective study enrolled 112 children (age 6-13.9 years) and 129 adults (age 14-70 years). A 2-week standard therapy phase (usual insulin regimen) was followed by 3 months of automated insulin delivery. Primary safety outcomes were incidence of severe hypoglycemia and diabetic ketoacidosis. Primary effectiveness outcomes were change in HbA
and percent time in sensor glucose range 70-180 mg/dL ("time in range").
A total of 235 participants (98% of enrolled, including 111 children and 124 adults) completed the study. HbA
was significantly reduced in children by 0.71% (7.8 mmol/mol) (mean ± SD: 7.67 ± 0.95% to 6.99 ± 0.63% 60 ± 10.4 mmol/mol to 53 ± 6.9 mmol/mol,
< 0.0001) and in adults by 0.38% (4.2 mmol/mol) (7.16 ± 0.86% to 6.78 ± 0.68% 55 ± 9.4 mmol/mol to 51 ± 7.4 mmol/mol,
< 0.0001). Time in range was improved from standard therapy by 15.6 ± 11.5% or 3.7 h/day in children and 9.3 ± 11.8% or 2.2 h/day in adults (both
< 0.0001). This was accomplished with a reduction in time in hypoglycemia <70 mg/dL among adults (median interquartile range: 2.00% 0.63, 4.06 to 1.09% 0.46, 1.75,
< 0.0001), while this parameter remained the same in children. There were three severe hypoglycemia events not attributable to automated insulin delivery malfunction and one diabetic ketoacidosis event from an infusion site failure.
This tubeless automated insulin delivery system was safe and allowed participants to significantly improve HbA
levels and time in target glucose range with a very low occurrence of hypoglycemia.
The coronavirus disease 2019 (COVID-19) pandemic likely affected youth with type 1 diabetes (T1D). We used electronic health record-extracted data to compare continuous glucose monitoring (CGM) ...metrics during 1 year of the pandemic with those of the previous year. The sample comprised CGM users, aged 1 to <18 years, with T1D duration ≥6 months (age <6 years) or ≥1 year (age ≥6 years). The prepandemic sample comprised 641 youth (52% female, aged 12.3 ± 3.5, T1D duration 6.0 ± 3.5 years). The pandemic sample comprised 648 youth (52% female, age 13.3 ± 3.5, duration 6.7 ± 3.8 years), with care delivered primarily through telemedicine. Mean CGM glucose was 6.3 mg/dL lower during the pandemic (187.3 ± 35.6) versus prepandemic (193.6 ± 33.0) (
< 0.001). A higher percentage of youth achieved glucose management indicator <7% during the pandemic than the prior year (
< 0.001). Lower CGM glucose values were observed during the COVID-19 pandemic. Future studies are needed to assess how changes in health care delivery, including telemedicine, and lifestyle during this time may have supported this improvement.
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.
This was a multicenter (
= 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.
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,
< 0.001, and Standard-CGM vs. BGM,
< 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 (
= 0.008 and 0.04) and BGM (
= 0.02 and 0.002).
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.
Aim: COVID-19 caused disruption with potential for changes in lifestyle and T1D care behaviors, especially for youth. We compared CGM-derived glucometrics during the COVID-19 pandemic with the ...previous year in a clinic-based pediatric sample with T1D using CGM. Method: We used EHR-extracted data to compare CGM metrics during the pandemic (3/16/20 -10/29/20) with the same calendar months in 2019. The sample comprised youth using CGM, aged 1-18 years, with T1D duration ≥6 months (age <6 years) or ≥1 year (age ≥6 years). Results: The pre-pandemic sample comprised 578 youth (53% female, age 12.4±3.5, T1D 6.2±3.5 years). The pandemic sample comprised 605 youth (54% female, age 13.4±3.6, T1D 6.8±3.8 years). Over 80% of youth were common to both samples. Mean CGM glucose was 7 mg/dL lower during the pandemic (186±35) vs. pre-pandemic (193±33) (p<.001). The proportion of youth with mean glucose <145 and 145-154 mg/dL increased 80-100% during the pandemic (5 to 9% and 5 to 10%, respectively), while the proportion with mean glucose ≥210 mg/dL decreased by 29% (31 to 22%). The % of youth with glucose management indicator (GMI) <7% increased by >110% (Figure). The 7-12y age group showed the largest shift in GMI: 8.0 pre- vs. 7.7% during pandemic (p=.003). Conclusion: There was a beneficial shift in glucose levels from pre to during the pandemic. Future studies are needed to assess how changes in healthcare during the pandemic may have improved glycemic outcomes.
To assess the efficacy and safety of closed-loop control (CLC) insulin delivery system in adolescents and young adults with type 1 diabetes.
Prespecified subanalysis of outcomes in adolescents and ...young adults aged 14-24 years old with type 1 diabetes in a previously published 6-month multicenter randomized trial. Participants were randomly assigned 2:1 to CLC (Tandem Control-IQ) or sensor augmented pump (SAP, various pumps+Dexcom G6 CGM) and followed for 6 months.
Mean age of the 63 participants was 17 years, median type 1 diabetes duration was 7 years, and mean baseline HbA1c was 8.1%. All 63 completed the trial. Time in range (TIR) increased by 13% with CLC versus decreasing by 1% with SAP (adjusted treatment group difference = +13% +3.1 h/day; 95% confidence interval CI 9-16,
< 0.001), which largely reflected a reduction in time >180 mg/dL (adjusted difference -12% -2.9 h/day,
< 0.001). Time <70 mg/dL decreased by 1.6% with CLC versus 0.3% with SAP (adjusted difference -0.7% -10 min/day, 95% CI -1.0% to -0.2%,
= 0.002). CLC use averaged 89% of the time for 6 months. The mean adjusted difference in HbA1c after 6 months was 0.30% in CLC versus SAP (95% CI -0.67 to +0.08,
= 0.13). There was one diabetic ketoacidosis episode in the CLC group.
CLC use for 6 months was substantial and associated with improved TIR and reduced hypoglycemia in adolescents and young adults with type 1 diabetes. Thus, CLC has the potential to improve glycemic outcomes in this challenging age group. The clinical trial was registered with ClinicalTrials.gov (NCT03563313).
Very young children with type 1 diabetes often struggle to achieve glycemic targets, putting them at risk for long-term complications and creating an immense management burden for caregivers. We ...conducted the first evaluation of the Omnipod 5 Automated Insulin Delivery System in this population.
A total of 80 children aged 2.0-5.9 years used the investigational system in a single-arm study for 13 weeks following 14 days of baseline data collection with their usual therapy.
There were no episodes of severe hypoglycemia or diabetic ketoacidosis. By study end, HbA1c decreased by 0.55% (6.0 mmol/mol) (P < 0.0001). Time with sensor glucose levels in target range 70-180 mg/dL increased by 10.9%, or 2.6 h/day (P < 0.0001), while time with levels <70 mg/dL declined by median 0.27% (P = 0.0204).
Use of the automated insulin delivery system was safe, and participants experienced improved glycemic measures and reduced hypoglycemia during the study phase compared with baseline.
PDF
