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

Abstract

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 <a:math xmlns:a="http://www.w3.org/1998/Math/MathML" id="M1"> <a:mtext>age</a:mtext> <a:mo>=</a:mo> <a:mn>58</a:mn> <a:mtext> </a:mtext> <a:mtext>y</a:mtext> </a:math> ) 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 <c:math xmlns:c="http://www.w3.org/1998/Math/MathML" id="M2"> <c:mi>t</c:mi> </c:math> -tests and Cohen’s <e:math xmlns:e="http://www.w3.org/1998/Math/MathML" id="M3"> <e:mi>d</e:mi> </e:math> effect sizes modeled glycemic and sleep changes and the magnitude of these changes from baseline to 9 months. Reduced hypoglycemia ( <g:math xmlns:g="http://www.w3.org/1998/Math/MathML" id="M4"> <g:mi>d</g:mi> <g:mo>=</g:mo> <g:mn>0.47</g:mn> <g:mo>‐</g:mo> <g:mn>0.79</g:mn> </g:math> ), reduced basal insulin requirements ( <i:math xmlns:i="http://www.w3.org/1998/Math/MathML" id="M5"> <i:mi>d</i:mi> <i:mo>=</i:mo> <i:mn>0.48</i:mn> </i:math> ), and a smaller glucose coefficient of variation ( <k:math xmlns:k="http://www.w3.org/1998/Math/MathML" id="M6"> <k:mi>d</k:mi> <k:mo>=</k:mo> <k:mn>0.47</k:mn> </k:math> ) 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 ( <m:math xmlns:m="http://www.w3.org/1998/Math/MathML" id="M7"> <m:mi>d</m:mi> <m:mo>=</m:mo> <m:mn>0.60</m:mn> </m:math> ), lability index ( <o:math xmlns:o="http://www.w3.org/1998/Math/MathML" id="M8"> <o:mi>d</o:mi> <o:mo>=</o:mo> <o:mn>0.50</o:mn> </o:math> ), HYPO score ( <q:math xmlns:q="http://www.w3.org/1998/Math/MathML" id="M9"> <q:mi>d</q:mi> <q:mo>=</q:mo> <q:mn>1.06</q:mn> </q:math> )). Shorter sleep onset latency ( <s:math xmlns:s="http://www.w3.org/1998/Math/MathML" id="M10"> <s:mi>d</s:mi> <s:mo>=</s:mo> <s:mn>1.53</s:mn> </s:math> ; <u:math xmlns:u="http://www.w3.org/1998/Math/MathML" id="M11"> <u:mi>p</u:mi> <u:mo>&lt;</u:mo> <u:mn>0.01</u:mn> </u:math> ), shorter sleep duration ( <w:math xmlns:w="http://www.w3.org/1998/Math/MathML" id="M12"> <w:mi>d</w:mi> <w:mo>=</w:mo> <w:mn>0.79</w:mn> </w:math> ), fewer total activity counts ( <y:math xmlns:y="http://www.w3.org/1998/Math/MathML" id="M13"> <y:mi>d</y:mi> <y:mo>=</y:mo> <y:mn>1.32</y:mn> </y:math> ), shorter average awakening length ( <ab:math xmlns:ab="http://www.w3.org/1998/Math/MathML" id="M14"> <ab:mi>d</ab:mi> <ab:mo>=</ab:mo> <ab:mn>0.46</ab:mn> </ab:math> ), and delays in sleep onset ( <cb:math xmlns:cb="http://www.w3.org/1998/Math/MathML" id="M15"> <cb:mi>d</cb:mi> <cb:mo>=</cb:mo> <cb:mn>1.06</cb:mn> </cb:math> ) and sleep midpoint ( <eb:math xmlns:eb="http://www.w3.org/1998/Math/MathML" id="M16"> <eb:mi>d</eb:mi> <eb:mo>=</eb:mo> <eb:mn>0.72</eb:mn> </eb:math> ) 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).

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