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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
Open accessAbstract
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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“A1C is currently recognized as the key surrogate marker for the development of longterm diabetes complications in people with type 1 and type 2 diabetes and has been used the primary endpoint for many CGM studies (1; 3; 4; 6; 32; 33).”
From Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range (2019) · cites this paper as [33]
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“A1C is currently recognized as the key surrogate marker for the development of longterm diabetes complications in people with type 1 and type 2 diabetes and has been used the primary endpoint for many CGM studies (1; 3; 4; 6; 32; 33).”
From Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range (2019) · cites this paper as [33]
Experimental — accuracy not yet measuredIn the citing paper
“Reductions in HbA1c have been reported with CGM use in people on multiple daily injection (MDI) therapy,19 and continuous subcutaneous insulin infusion therapy,20 with reduced time spent in hypoglycemia,20 and improved hypoglycemia awareness.21”
From Increased Time in Range and Fewer Missed Bolus Injections After Introduction of a Smart Connected Insulin Pen (2020) · cites this paper as [20]
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Citations
Cites
Standards of Medical Care in Diabetes
Power, D. V. (2006) · Diabetes Care · doi:10.2337/diacare.29.02.06.dc05-1593 · Cited by 8,676
Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes
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Self-citationStandards of medical care in diabetes—2011
American Diabetes Association (2011) · Diabetes Care · doi:10.2337/dc11-s011 · Cited by 2,880
Continuous glucose monitoring and intensive treatment of type 1 diabetes
(2008) · New England Journal of Medicine · doi:10.1056/nejmoa0805017 · Cited by 1,559
Self-citationEffectiveness of Sensor-Augmented Insulin-Pump Therapy in Type 1 Diabetes
Bergenstal, R. M., Tamborlane, W. V., Ahmann, A., Buse, J. B., Dailey, G., Davis, S. N., Joyce, C., Peoples, T., Perkins, B. A., Welsh, J. B., et al. (2010) · New England Journal of Medicine · doi:10.1056/nejmoa1002853 · Cited by 894
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Self-citationEffect of Continuous Glucose Monitoring on Hypoglycemia in Type 1 Diabetes
Battelino, T., Phillip, M., Bratina, N., Nimri, R., Oskarsson, P., & Bolinder, J. (2011) · Diabetes Care · doi:10.2337/dc10-1989 · Cited by 496
Self-citationMisso, M. L., Egberts, K. J., Page, M., O'Connor, D., & Shaw, J. (2010) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd005103.pub2 · Cited by 406
The effect of continuous glucose monitoring in well-controlled type 1 diabetes
Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group (2009) · Diabetes Care · doi:10.2337/dc09-0108 · Cited by 399
Sensor-Augmented Insulin Pump Therapy: Results of the First Randomized Treat-to-Target Study
Hirsch, I. B., Abelseth, J. M., Bode, B. W., Fischer, J. S., KAUFMAN, F. R., Mastrototaro, J. J., Parkin, C. G., Wolpert, H. A., & Buckingham, B. A. (2008) · Diabetes Technology & Therapeutics · doi:10.1089/dia.2008.0068 · Cited by 297
Continuous glucose monitoring systems for type 1 diabetes mellitus
Langendam, M., Luijf, Y. M., Hooft, L., DeVries, J. H., Mudde, A. H., & Scholten, R. J. (2012) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd008101.pub2 · Cited by 262
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and the PedPump Study Group, Danne, T., Battelino, T., Jarosz-Chobot, P. A., Kordonouri, O., Pańkowska, E., Ludvigsson, J., Schober, E., Kaprio, E., Saukkonen, T. T., et al. (2008) · Diabetologia · doi:10.1007/s00125-008-1072-2 · Cited by 138
Self-citationRiveline, J., Schaepelynck, P., Chaillous, L., Renard, É., Sola‐Gazagnes, A., Penfornis, A., Tubiana‐Rufi, N., Sulmont, V., Catargi, B., Lukas, C., et al. (2012) · Diabetes Care · doi:10.2337/dc11-2021 · Cited by 99
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Raccah, D., Sulmont, V., Reznik, Y., Guerci, B., Renard, É., Hanaire, H. P., Jeandidier, N., & Nicolino, M. P. (2010) · Avances en Diabetología · doi:10.1016/s1134-3230(10)61016-2 · Cited by 36
Conget, I., Battelino, T., Giménez, M., Gough, H., Castañeda, J., & Bolinder, J. (2010) · Diabetes Technology & Therapeutics · doi:10.1089/dia.2010.0107 · Cited by 26
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Battelino, T., Danne, T., Bergenstal, R. M., Amiel, S. A., Beck, R., Biester, T., Bosi, E., Buckingham, B. A., Cefalu, W. T., Close, K. L., et al. (2019) · Diabetes Care · doi:10.2337/dci19-0028 · Cited by 4,237
Self-citationInternational consensus on use of continuous glucose monitoring
Danne, T., Nimri, R., Battelino, T., Bergenstal, R. M., Close, K. L., DeVries, J. H., Garg, S., Heinemann, L., Hirsch, I., Amiel, S. A., et al. (2017) · Diabetes Care · doi:10.2337/dc17-1600 · Cited by 2,069
Self-citation6. Glycemic Targets: Standards of Medical Care in Diabetes—2022
American Diabetes Association Professional Practice Committee (2022) · Diabetes Care · doi:10.2337/dc22-s006 · Cited by 1,403
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Bolinder, J., Antuna, R., Geelhoed-Duijvestijn, P., Kröger, J., & Weitgasser, R. (2016) · The Lancet · doi:10.1016/s0140-6736(16)31535-5 · Cited by 893
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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.
- Venue
- Diabetologia
- Published
- 2012-09-11
- Volume
- 55
- Issue
- 12
- Pages
- 3155-3162
- ISSN
- 0012-186X (ISSN-L)
- 1432-0428
- 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
- hybrid
- doi.org
- 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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