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

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the SWITCH Study Group, Battelino, T., Conget, I., Olsen, B., Schütz-Fuhrmann, I., Hommel, E., Hoogma, R., Schierloh, U., Sulli, N., Bolinder, J.·2012·Diabetologia
DOI 10.1007/s00125-012-2708-9PMC PMC3483098
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Abstract

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.

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Fig. 1 Participant disposition
Fig. 1 Participant dispositionCC BY-NC · PubMed Central
Fig. 2 Mean (±SEM) HbA1c in participants randomised to Off/On (solid line) and On/Off (dashed line) sequences (all available observations): months −1 to 0: run in period; months 1 to 6: first period; months 7 to 10: washout; months 11–16: second period. To convert values for HbA1c in % into mmol/mol, subtract 2.15 and multiply by 10.929
Fig. 2 Mean (±SEM) HbA1c in participants randomised to Off/On (solid line) and On/Off (dashed line) sequences (all available observations): months −1 to 0: run in period; months 1 to 6: first period; months 7 to 10: washout; months 11–16: second period. To convert values for HbA1c in % into mmol/mol, subtract 2.15 and multiply by 10.929CC BY-NC · PubMed Central

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Metadata

Authors
the SWITCH Study Group, Battelino, T., Conget, I., Olsen, B., Schütz-Fuhrmann, I., Hommel, E., Hoogma, R., Schierloh, U., Sulli, N., & Bolinder, J.
Affiliations
  • University of Ljubljana (SI)
  • Glostrup Hospital (DK)
  • Klinik Hietzing (AT)
  • Groene Hart Ziekenhuis (NL)
  • Centre Hospitalier de Luxembourg (LU)
  • Karolinska University Hospital (SE)
Corresponding author
Battelino, T.
ORCID
Venue
Diabetologia
Publisher
Springer Science and Business Media LLC
Published
2012-09-11
Volume
55
Issue
12
Pages
3155-3162
ISSN
  • 0012-186X (ISSN-L)
  • 1432-0428
DOI
10.1007/s00125-012-2708-9
PMC
PMC3483098
OpenAlex
W2075474575
Cited by
494
References
22
Citations by year
2026: 14 · 2025: 20 · 2024: 28 · 2023: 27 · 2022: 27 · 2021: 52 · 2020: 52 · 2019: 52 · 2018: 53 · 2017: 44 · 2016: 39 · 2015: 28 · 2014: 30 · 2013: 25 · 2012: 1
FWCI
21.56
Type
journal article
Language
en
Open access
Licence
cc-by-nc
Locations
  • Diabetologia (publishedVersion, cc-by-nc)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by-nc)
  • PubMed Central (publishedVersion, cc-by-nc)
  • PubMed (publishedVersion)
  • Open Repository and Bibliography (University of Luxembourg) (submittedVersion, cc-by-nc-sa)
  • IRIS Research product catalog (Sapienza University of Rome) (submittedVersion)
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
Keywords
continuous glucose monitoring, type 1 diabetes, insulin pump therapy, artificial pancreas, HbA1c, glycemic control, hypoglycemia, bolus insulin, children and adults, crossover trial, cost-effectiveness, quality of life
MeSH terms
Adolescent, Adult, Aged, Blood Glucose, Child, Diabetes Mellitus, Type 1, Female, Humans, Hyperglycemia, Hypoglycemic Agents, Insulin, Insulin Infusion Systems, Male, Middle Aged, Monitoring, Physiologic, Blood Glucose Self-Monitoring, Biosensing Techniques, Treatment Outcome, Cross-Over Studies

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