scholarly journals Characterizing Glycemic Control and Sleep in Adults with Long-Standing Type 1 Diabetes and Hypoglycemia Unawareness Initiating Hybrid Closed Loop Insulin Delivery

2021 ◽  
Vol 2021 ◽  
pp. 1-8
Author(s):  
Susan Kohl Malone ◽  
Amy J. Peleckis ◽  
Laura Grunin ◽  
Gary Yu ◽  
Sooyong Jang ◽  
...  

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).

SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A387-A388
Author(s):  
S K Malone ◽  
A J Peleckis ◽  
A I Pack ◽  
N Perez ◽  
G Yu ◽  
...  

Abstract Introduction Nocturnal hypoglycemia is life threatening for individuals with type 1 diabetes (T1D) due to loss of hypoglycemia symptom recognition (hypoglycemia unawareness) and impaired glucose counterregulation. 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. Methods Six adults (median age=58y,T1D duration=41y) participated in an 18-month ongoing clinical trial assessing the effectiveness of an HCL system. Sleep and glycemic control were measured concurrently using wrist actigraphs and CGM at baseline (1 week) and months 3 and 6 (3 weeks) following HCL initiation. BMI and hemoglobin A1c (HbA1c) were collected at all timepoints. Spearman’s correlations modeled associations between sleep, BMI, and glycemic control at each time point. Repeated ANOVAs modeled sleep and glycemic control changes from baseline to 3 months and to 6 months. Results Sleep and glycemic control indices showed significant associations at baseline and 3 months. More time-in-bed and later sleep offset related to higher HbA1c levels at baseline. Later sleep onset, midpoint and offset, and greater sleep efficiency associated with greater %time with hyperglycemia (glucose &gt;180 mg/dL) or hypoglycemia (glucose &lt;70 mg/dL) at baseline and 3 months. Longer sleep duration and greater sleep efficiency related to greater %time with hyperglycemia at 3 months. At 3 months, more wake after sleep onset associated with lower HbA1c levels and longer nocturnal awakenings and more sleep fragmentation associated with less glycemic variability. While both sleep and glycemic control improved from baseline to 3 and 6 months, these were not statistically significant. Conclusion Various dimensions of actigraphic sleep related to concurrently estimated glycemic indices indicative of poorer glycemic control and HbA1c across time in adults with long-standing T1D and hypoglycemia unawareness. Support This work was supported by NIH R01DK117488 (NG), R01DK091331 (MRR), and K99NR017416 (SKM).


Diabetes ◽  
2019 ◽  
Vol 68 (Supplement 1) ◽  
pp. 1065-P ◽  
Author(s):  
ANASTASIOS KOUTSOVASILIS ◽  
ALEXIOS SOTIROPOULOS ◽  
ANASTASIA ANTONIOU ◽  
VASILIOS KORDINAS ◽  
DESPINA PAPADAKI ◽  
...  

Author(s):  
Goran Petrovski ◽  
Fawziya Al Khalaf ◽  
Judith Campbell ◽  
Fareeda Umer ◽  
Douha Almajaly ◽  
...  

Abstract Objective To evaluate the effect of a 1-year hybrid closed-loop (HCL) system on glycemic control in children and adolescents with type 1 diabetes (T1D) previously treated with multiple daily injections (MDI). Methods This was a 1-year observational study, as a continuation of the previous 3 months prospective study of pediatric patients with T1D conducted at Sidra Medicine in Qatar. The study enrolled individuals aged 7–18 years with T1D > 1 year, on MDI with self-monitoring of blood glucose or continuous glucose monitoring, with no prior pump experience, and with an HbA1c level < 12.5% (< 113 mmol/mol). After the first 3 months of HCL use, patients were followed at 6, 9 and 12 months, where HbA1c was obtained and pump data were collected. Results All 30 participants (age 10.24 ± 2.6 years) who initiated HCL completed 12 months of HCL system use in Auto Mode. The participants used the sensor 88.4 ± 6.5% of the time with Auto Mode usage 85.6 ± 7.4% during 12 months of HCL system use. HbA1c decreased from 8.2 ± 1.4% (66 ± 15.3 mmol/mol) at baseline, to 6.7 ± 0.5% (50 ± 5.5 mmol/mol) at 3 months (p = 0.02) and remained stable to 7.1 ± 0.6 (54 ± 6.6 mmol/mol) at 12 months (p = 0.02). TIR (70–180 mg/dL) increased from 46.9% at baseline to 71.9% at 1 month and remained above 70% during the 12 months of HCL use. Conclusion HCL system (MiniMed 670G) in children and adolescents previously treated with MDI significantly improves glycemic outcomes (HbA1c and Time in Ranges) immediately during the first month. This improved glycemic control was maintained over the 1 year following Auto Mode initiation.


2020 ◽  
Author(s):  
Vera Lehmann ◽  
Thomas Zueger ◽  
Anna Zeder ◽  
Sam Scott ◽  
Lia Bally ◽  
...  

<i>Objective</i> <p>To assess the association between daily carbohydrate (CHO) intake and glycemic control in adult hybrid closed-loop (HCL) users with type 1 diabetes mellitus (T1D).</p> <p><i>Research Design and Methods</i></p> <p>Mean individual daily CHO intake (MIDC) and deviation from MIDC (rMIDC; ≤80% low; 81-120% medium, >120% high CHO consumption) were compared with parameters of glycemic control assessed by continuous glucose monitoring (CGM). </p> <p><i>Results</i></p> <p>Records from 36 patients (26 male, 10 female; age 36.9±13.5y; HbA<sub>1c</sub> 7.1±0.9% [54±10mmol/mol]) provided 810 days of data (22.5±6.7 days per patient). Time in range (70-180mg/dL) for low, medium, and high CHO consumption was 77.4±15.4%, 75.2±16.7% and 70.4±17.8%, respectively (<i>p</i><0.001). Time above range (>180mg/dL) was 20.1±14.7%, 22.0±16.9% and 27.2±18.4%, respectively (<i>p</i><0.001). There was no between-group difference for time in hypoglycemia (<70mg/dL; <i>p</i>=0.50).</p> <p><i>Conclusions</i></p> Daily CHO intake was inversely associated with glycemic control in adults with T1D using a HCL system. Lower CHO intake may be a strategy to optimize glucose control in HCL users.


2021 ◽  
Vol 1 (6) ◽  
Author(s):  
Health Technology Assessment Team

The CADTH Health Technology Expert Review Panel (HTERP) suggests that hybrid closed-loop insulin delivery (HCL) systems hold promise for the care of people with type 1 diabetes. HTERP considers that, at present, there are insufficient long-term data on clinically relevant and patient-important outcomes to recommend how extensive the role of HCL systems should be in care. HTERP recommends the collection of robust and comparative data for consideration of future reassessments that compare HCL systems to existing insulin delivery and glucose monitoring methods in terms of glycated hemoglobin (hemoglobin A1C); time-in-range; time above and below range; glycemic variability; quality of life; patient, parent or caregiver, and health care provider satisfaction; diabetes-related complications; discontinuation rates; and health system impact. Robust data are collected in well-designed comparative studies that are, among other considerations, of sufficient duration to ensure a clinically meaningful outcome assessment.


2015 ◽  
Vol 9 (6) ◽  
pp. 1346-1347 ◽  
Author(s):  
Martin Tauschmann ◽  
Hood Thabit ◽  
Lalantha Leelarathna ◽  
Daniela Elleri ◽  
Janet M. Allen ◽  
...  

2020 ◽  
Author(s):  
Vera Lehmann ◽  
Thomas Zueger ◽  
Anna Zeder ◽  
Sam Scott ◽  
Lia Bally ◽  
...  

<i>Objective</i> <p>To assess the association between daily carbohydrate (CHO) intake and glycemic control in adult hybrid closed-loop (HCL) users with type 1 diabetes mellitus (T1D).</p> <p><i>Research Design and Methods</i></p> <p>Mean individual daily CHO intake (MIDC) and deviation from MIDC (rMIDC; ≤80% low; 81-120% medium, >120% high CHO consumption) were compared with parameters of glycemic control assessed by continuous glucose monitoring (CGM). </p> <p><i>Results</i></p> <p>Records from 36 patients (26 male, 10 female; age 36.9±13.5y; HbA<sub>1c</sub> 7.1±0.9% [54±10mmol/mol]) provided 810 days of data (22.5±6.7 days per patient). Time in range (70-180mg/dL) for low, medium, and high CHO consumption was 77.4±15.4%, 75.2±16.7% and 70.4±17.8%, respectively (<i>p</i><0.001). Time above range (>180mg/dL) was 20.1±14.7%, 22.0±16.9% and 27.2±18.4%, respectively (<i>p</i><0.001). There was no between-group difference for time in hypoglycemia (<70mg/dL; <i>p</i>=0.50).</p> <p><i>Conclusions</i></p> Daily CHO intake was inversely associated with glycemic control in adults with T1D using a HCL system. Lower CHO intake may be a strategy to optimize glucose control in HCL users.


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