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Journal Article Clinical Trial Ppublish 5 citations

PubMed: 37449426 DOI: 10.1177/19322968231182406

Prolonged Use of an Automated Insulin Delivery System Improves Sleep in Long-Standing Type 1 Diabetes Complicated by Impaired Awareness of Hypoglycemia.

J Diabetes Sci Technol 18(6):1416-1423

Authors: Susan Kohl Malone, Austin M Matus, Anneliese J Flatt, Amy J Peleckis, Laura Grunin, Gary Yu, Sooyong Jang, James Weimer, Insup Lee, Michael R Rickels, Namni Goel

Affiliations

  • Rory Meyers College of Nursing, New York University, New York, NY, USA.
  • School of Nursing, University of Pennsylvania, Philadelphia, PA, USA.
  • Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, and Institute for Diabetes, Obesity, and Metabolism, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
  • PRECISE Center, Department of Computer and Information Science, School of Engineering and Applied Sciences, University of Pennsylvania, Philadelphia, PA, USA.
  • Biological Rhythms Research Laboratory, Department of Psychiatry and Behavioral Sciences, Rush University Medical Center, Chicago, IL, USA.

Abstract

BACKGROUND

This study assessed changes in actigraphy-estimated sleep and glycemic outcomes after initiating automated insulin delivery (AID).

METHODS

Ten adults with long-standing type 1 diabetes and impaired awareness of hypoglycemia (IAH) participated in an 18-month clinical trial assessing an AID intervention on hypoglycemia and counter-regulatory mechanisms. Data from eight participants (median age = 58 years) with concurrent wrist actigraph and continuous glucose monitoring (CGM) data were used in the present analyses. Actigraphs and CGM measured sleep and glycemic control at baseline (one week) and months 3, 6, 9, 12, 15, and 18 (three weeks) following AID initiation. HypoCount software integrated actigraphy with CGM data to separate wake and sleep-associated glycemic measures. Paired sample t-tests and Cohen's d effect sizes modeled changes and their magnitude in sleep, glycemic control, IAH (Clarke score), hypoglycemia severity (HYPO score), hypoglycemia exposure (CGM), and glycemic variability (lability index [LI]; CGM coefficient-of-variation [CV]) from baseline to 18 months.

RESULTS

Sleep improved from baseline to 18 months (shorter sleep latency [P < .05, d = 1.74], later sleep offset [P < .05, d = 0.90], less wake after sleep onset [P < .01, d = 1.43]). Later sleep onset (d = 0.74) and sleep midpoint (d = 0.77) showed medium effect sizes. Sleep improvements were evident from 12 to 15 months after AID initiation and were preceded by improved hypoglycemia awareness (Clarke score [d = 1.18]), reduced hypoglycemia severity (HYPO score [d = 2.13]), reduced sleep-associated hypoglycemia (percent time glucose was < 54 mg/dL, < 60 mg/dL,< 70 mg/dL; d = 0.66-0.81), and reduced glucose variability (LI, d = 0.86; CV, d = 0.62).

CONCLUSION

AID improved sleep initiation and maintenance. Improved awareness of hypoglycemia, reduced hypoglycemia severity, hypoglycemia exposure, and glucose variability preceded sleep improvements.This trial is registered with ClinicalTrials.gov NCT03215914 https://clinicaltrials.gov/ct2/show/NCT03215914.

MeSH

Diabetes Mellitus, Insulin, Sleep, Actigraphy, Hypoglycemia, Diabetes Mellitus, Type 1, Glycemic Control

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