Dataset Information

Initiating hybrid closed loop: A program evaluation of an educator-led Control-IQ follow-up at a large pediatric clinic.

ABSTRACT:

Background

Control-IQ (Tandem Diabetes) is a hybrid closed-loop (HCL) system that users self-initiate after completing online training. Best practices for clinical follow-up are not known. Our quality improvement objective was to evaluate the usefulness of an educator-led follow-up program for new HCL users in a type 1 diabetes pediatric clinic.

Methods

We implemented an ''HCLCheck-in'' program, first determining when users started HCL, then having diabetes educators contact them for a follow-up call 2-weeks after start. Educators used a Clinical Tool to inform insulin dose and behavior recommendations, and used four benchmarks to determine need for further follow-up: ≥71% HCL use, ≥71% CGM use, ≥60% Time-in-Range (TIR, 70-180 mg/dL), <5% below 70 mg/dL. Family and educator satisfaction were surveyed.

Results

One-hundred-twenty-three youth [mean age 13.6 ± 3.7 y, 53.7% female, mean HbA1c 7.6 ± 1.4% (60 mmol/mol)] completed an HCLCheck-in call a median (IQR) of 18(15, 21) days post-HCL start. 74 users (60%) surpassed benchmarks with 94% HCL use and 71% TIR. Of the 49 who did not, 16 completed a second call, and improved median TIR 12.5% (p = 0.03). HCL users reported high satisfaction with the program overall [median 10 (9, 10) out of 10]. Educators spent a median of 45 (32,70) minutes per user and rated satisfaction with the program as 8 (7,9.5) and the Tool as 9 (9, 10).

Conclusion

Our HCLCheck-in program received high satisfaction ratings and resulted in improved TIR for those initially not meeting benchmarks, suggesting users may benefit from early follow-up. Similar programs may be beneficial for other new technologies.

SUBMITTER: Messer LH

PROVIDER: S-EPMC8252603 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Nocturnal hypoglycemia is life threatening for individuals with type 1 diabetes (T1D) due to loss of hypoglycemia symptom recognition (hypoglycemia unawareness) and impaired glucose counter regulation. These individuals also show disturbed sleep, which may result from glycemic dysregulation. Whether use of a hybrid closed loop (HCL) insulin delivery system with integrated continuous glucose monitoring (CGM) designed for improving glycemic control, relates to better sleep across time in this population remains unknown. The purpose of this study was to describe long-term changes in glycemic control and objective sleep after initiating hybrid closed loop (HCL) insulin delivery in adults with type 1 diabetes and hypoglycemia unawareness. To accomplish this, six adults (median age = 58 y) participated in an 18-month ongoing trial assessing HCL effectiveness. Glycemic control and sleep were measured using continuous glucose monitoring and wrist accelerometers every 3 months. Paired sample t-tests and Cohen's d effect sizes modeled glycemic and sleep changes and the magnitude of these changes from baseline to 9 months. Reduced hypoglycemia (d = 0.47-0.79), reduced basal insulin requirements (d = 0.48), and a smaller glucose coefficient of variation (d = 0.47) occurred with medium-large effect sizes from baseline to 9 months. Hypoglycemia awareness improved from baseline to 6 months with medium-large effect sizes (Clarke score (d = 0.60), lability index (d = 0.50), HYPO score (d = 1.06)). Shorter sleep onset latency (d = 1.53; p < 0.01), shorter sleep duration (d = 0.79), fewer total activity counts (d = 1.32), shorter average awakening length (d = 0.46), and delays in sleep onset (d = 1.06) and sleep midpoint (d = 0.72) occurred with medium-large effect sizes from baseline to 9 months. HCL led to clinically significant reductions in hypoglycemia and improved hypoglycemia awareness. Sleep showed a delayed onset, reduced awakening length and onset latency, and maintenance of high sleep efficiency after initiating HCL. Our findings add to the limited evidence on the relationships between diabetes therapeutic technologies and sleep health. This trial is registered with ClinicalTrials.gov (NCT03215914).