The use and efficacy of continuous glucose monitoring in type 1 diabetes treated with insulin pump therapy: a randomised controlled trial

• Published in: Diabetologia Vol. 55; no. 12; pp. 3155 - 3162
• Main Authors: Battelino, T., Conget, I., Olsen, B., Schütz-Fuhrmann, I., Hommel, E., Hoogma, R., Schierloh, U., Sulli, N., Bolinder, J.
• Format: Journal Article
• Language: English
• Published: Berlin/Heidelberg Springer-Verlag 01.12.2012; Springer; Springer Nature B.V
• Subjects: Adolescent; Adult; Adults; Aged; Biological and medical sciences; Biosensing Techniques; Blood Glucose - metabolism; Blood Glucose Self-Monitoring; Case reports; Child; Cross-Over Studies; Diabetes; Diabetes Mellitus, Type 1 - blood; Diabetes Mellitus, Type 1 - drug therapy; Diabetes. Impaired glucose tolerance; Endocrine pancreas. Apud cells (diseases); Endocrinopathies; Etiopathogenesis. Screening. Investigations. Target tissue resistance; Female; Glucose monitoring; Hospitals; Human Physiology; Humans; Hyperglycemia - blood; Hyperglycemia - drug therapy; Hypoglycemia; Hypoglycemic Agents - administration & dosage; Infusion pumps; Insulin; Insulin - administration & dosage; Insulin - analogs & derivatives; Insulin Infusion Systems; Internal Medicine; Male; Medical sciences; Medicin och hälsovetenskap; Medicine; Medicine & Public Health; Metabolic Diseases; Metabolism; Middle Aged; Monitoring, Physiologic - methods; Pediatrics; Sensors; Treatment Outcome; Denmark; Switzerland; Luxembourg; Continuous glucose monitoring; Insulin pump therapy; Diabetes mellitus type 1; Glycaemic control; Sensor-augmented insulin pump therapy; Randomised controlled trial; Endocrinopathy; Immunopathology; Type 1 diabetes; Insulin pump; Autoimmune disease; Glucose
• ISSN: 0012-186X; 1432-0428; 1432-0428
• DOI: 10.1007/s00125-012-2708-9

Aims/hypothesis The aim of this multicentre, randomised, controlled crossover study was to determine the efficacy of adding continuous glucose monitoring (CGM) to insulin pump therapy (CSII) in type 1 diabetes. Methods Children and adults ( n  = 153) on CSII with HbA 1c 7.5–9.5% (58.5–80.3 mmol/mol) were randomised to (CGM) a Sensor On or Sensor Off arm for 6 months. After 4 months’ washout, participants crossed over to the other arm for 6 months. Paediatric and adult participants were separately electronically randomised through the case report form according to a predefined randomisation sequence in eight secondary and tertiary centres. The primary outcome was the difference in HbA 1c levels between arms after 6 months. Results Seventy-seven participants were randomised to the On/Off sequence and 76 to the Off/On sequence; all were included in the primary analysis. The mean difference in HbA 1c was –0.43% (–4.74 mmol/mol) in favour of the Sensor On arm (8.04% [64.34 mmol/mol] vs 8.47% [69.08 mmol/mol]; 95% CI −0.32%, −0.55% [−3.50, −6.01 mmol/mol]; p  < 0.001). Following cessation of glucose sensing, HbA 1c reverted to baseline levels. Less time was spent with sensor glucose <3.9 mmol/l during the Sensor On arm than in the Sensor Off arm (19 vs 31 min/day; p  = 0.009). The mean number of daily boluses increased in the Sensor On arm (6.8 ± 2.5 vs 5.8 ± 1.9, p  < 0.0001), together with the frequency of use of the temporary basal rate (0.75 ± 1.11 vs 0.26 ± 0.47, p  < 0.0001) and manual insulin suspend (0.91 ± 1.25 vs 0.70 ± 0.75, p  < 0.018) functions. Four vs two events of severe hypoglycaemia occurred in the Sensor On and Sensor Off arm, respectively ( p  = 0.40). Conclusions/interpretation Continuous glucose monitoring was associated with decreased HbA 1c levels and time spent in hypoglycaemia in individuals with type 1 diabetes using CSII. More frequent self-adjustments of insulin therapy may have contributed to these effects. Trial registration ClinicalTrials.gov registration no. NCT00598663. Funding The study was funded by Medtronic International Trading Sarl Switzerland.