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A Randomized, Prospective Trial Comparing the Efficacy of Continuous Subcutaneous Insulin Infusion With Multiple Daily Injections Using Insulin Glargine
Open accessAbstract
OBJECTIVE—The efficacy of the insulin analogs now available for multiple daily injection (MDI) and continuous subcutaneous insulin infusion (CSII) therapy in type 1 diabetes has not yet been established in pediatric patients. Our principal aim in this short-term study was to compare the efficacy of CSII to MDI with glargine in lowering HbA1c levels in children and adolescents with type 1 diabetes. RESEARCH DESIGN AND METHODS—Thirty-two youth with type 1 diabetes (age 8–21 years) were randomly assigned to receive either MDI treatment with once-daily glargine and premeal/snack insulin aspart or CSII with insulin aspart. Dose titration in both groups was based on home self-monitored blood glucose measurements and monthly HbA1c. HbA1c, total daily insulin dose (TDD), self-monitored blood glucose readings, and adverse events were compared after 16 weeks of therapy. RESULTS—While there was no significant change in the glargine group (HbA1c 8.2% at baseline vs. 8.1% at 16 weeks), youth randomized to CSII had a sharp reduction in HbA1c levels, from 8.1 to 7.2% after 16 weeks of therapy (P < 0.02 vs. baseline and <0.05 vs. glargine group). TDD was unchanged in the glargine group, but significantly dropped with CSII (1.4 units/kg at baseline vs. 0.9 units/kg at 16 weeks, P < 0.01). Both groups had similar basal doses and insulin-to-carbohydrate ratios. Fasting self-monitored blood glucose was similar in both groups, but lunch, dinner, and bedtime readings were significantly lower in the CSII group (P < 0.01). CONCLUSIONS—Lower HbA1c and premeal glucose levels were more achievable in this short-term study with CSII than with glargine-based MDI treatment. CSII is an efficacious treatment to improve metabolic control in youth with type 1 diabetes.
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“However, RCTs that compared insulin pumps and MDI with rapidacting insulin analogs demonstrated a modest improvement in A1C levels in participants on insulin pump therapy (178,179).”
From 7. Diabetes Technology: Standards of Care in Diabetes—2025 (2025) · cites this paper as [178]
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ResultContinuous Subcutaneous Insulin Infusion versus Multiple Daily Injections of Insulin
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“At present, multiple daily insulin injection therapy remains common, continuous subcutaneous insulin infusion shows benefit in reducing haemoglobin A1c in some [12,13], but not all, [14] studies, and continuous glucose monitoring data are only available retrospectively [15].”
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“Poor compliance with the requirements of frequent injections is a major contributing cause of failure to achieve target plasma glucose and A1C levels in adolescents with type 1 diabetes using multiple daily injection regimes (6).”
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“Doyle et al. 9 found that pediatric patients on CSII had significantly better metabolic control compared with those on a basal/bolus insulin regimen using a combination of rapid-acting insulin aspart and long-acting glargine insulin.”
Association of CTLA-4 (+49A/G) Gene Polymorphism with Type 1 Diabetes Mellitus in Egyptian Children
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“To our knowledge, only one study reported the demographic characteristics of pediatric CSII users (Doyle et al., 2004), which were comparable with our current sample.”
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“trials in youth with type 1 diabetes [22,23,32] reach the conclusion that both CSII and glargine improve glycaemic control, reduce the blood glucose variability and decrease the frequency of severe hypoglycaemic events, with the CSII probably being the more efficacious approach in terms of reduction of hypoglycaemia […”
BackgroundNew technologies for diabetes: a review of the present and the future
Ramchandani, N., & Heptulla, R. A. (2012) · International Journal of Pediatric Endocrinology · doi:10.1186/1687-9856-2012-28 · Cited by 39
“better quality of life in patients who use insulin pumps compared to those on multiple daily injections (MDI) [58-79].”
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Bußmann, A. B., Leistner, H., Zhou, D., Wackerle, M., Congar, Y., Richter, M., & Hubbuch, J. J. (2021) · Applied Sciences · doi:10.3390/app11178008 · Cited by 34
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MethodImproving glycaemic control in children and adolescents: which aspects of therapy really matter?
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“There have been relatively few trials to date with glargine as the basal insulin in the MDI comparator group [30,31].”
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An Update on the Long‐Acting Insulin Analogue Glargine
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“As CGMs have evolved for patient use, earlier mixed results [13,14,15] have shifted to show benefits [16,17], especially when using CGM to augment insulin pump therapy [18-21].”
BackgroundThe renaissance of insulin pump treatment in childhood type 1 diabetes
Tamborlane, W. V., Swan, K. L., Sikes, K. A., Steffen, A. T., & WEINZIMER, S. A. (2006) · Reviews in Endocrine and Metabolic Disorders · doi:10.1007/s11154-006-9018-9 · Cited by 27
“In contrast, patients randomized to CSII were able to significantly lower HbA1c values compared to their own baseline levels and versus the glargine group at 16 weeks [34].”
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HLA-DQB1* alleles and genetic susceptibility to type 1 diabetes mellitus
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Are Glucose Readings Sufficient to Adjust Insulin Dosage?
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InfluentialDiabetes Technology During the Past 30 Years: A Lot of Changes and Mostly for the Better
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“Controlled studies have shown lower HbA1c with intensive treatment regimens, compared to more conventional treatment (9–11), while comparisons between multiple injections (MDI) and CSII have shown improvement in metabolic control with CSII over glargine (12) or concluded that there was not enough data to give a conclu…”
BackgroundLong-Term Metabolic Effects of Continuous Subcutaneous Insulin Infusion Therapy in Type 1 Diabetes
Cohen, N. D., Hong, E. S., Drie, C. V., Balkau, B., & Shaw, J. E. (2013) · Diabetes Technology & Therapeutics · doi:10.1089/dia.2012.0331 · Cited by 21
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“Some noncontrolled cohort studies [19] and randomized clinical trials (RCTs) [24] reported a decrease in HbA1c with insulin pump therapy compared to MDI [19,24], whereas others did not [25].”
BackgroundImpact of insulin pumps on glycaemic control in a pump‐naïve paediatric regional population
de Bock, M. I., Gunn, A. J., Holt, J., Derraik, J. G. B., Reed, P., Cutfield, W. S., Mouat, F., Hofman, P. L., & Jefferies, C. (2011) · Journal of Paediatrics and Child Health · doi:10.1111/j.1440-1754.2011.02245.x · Cited by 21
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A evolução da insulinoterapia no diabetes melito tipo 1
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A Comparative Pulse Accuracy Study of Two Commercially Available Patch Insulin Infusion Pumps
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“Other investigators have demonstrated no change in BMI during pump treatment (25,17).”
BackgroundDiabetes mellitus type 1 in adults
Dedov, I. I., Shestakova, M. V., Mayorov, A. Y., Шамхалова, М. Ш., Nikonova, T. V., Sukhareva, O. Y., Пекарева, Е. В., Ibragimova, L. I., Mikhina, M. S., Galstyan, G. R., et al. (2020) · Diabetes Mellitus · doi:10.14341/dm12505 · Cited by 19
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on behalf of the North West England Paediatric Diabetes Network, Senniappan, S., Hine, P., Tang, W., Campbell, J., Bone, M., Sankar, V., Robinson, M., Smith, C. P., Cooper, C., et al. (2011) · European Journal of Pediatrics · doi:10.1007/s00431-011-1482-x · Cited by 18
The effort required to achieve and maintain optimal glycemic control
Rosenthal, E. S., Bashan, E., Herman, W. H., & Hodish, I. (2011) · Journal of Diabetes and its Complications · doi:10.1016/j.jdiacomp.2011.01.002 · Cited by 18
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Insulin Pump Treatment of Childhood Type 1 Diabetes
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Self-citationSämann, A., Lehmann, T., Kloos, C., Braun, A., Hunger-Dathe, W., Wolf, G., & Müller, U. (2008) · Diabetic Medicine · doi:10.1111/j.1464-5491.2008.02406.x · Cited by 17
Intensive insulin therapy today: ‘basal-bolus’ using multiple daily injections or CSII?
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“Fasting selfmonitored blood glucose levels were similar in both groups, while lunch, dinner, and bedtime levels were significantly lower in the CSII group.(3) The same concept of switching to CSII therapy was evaluated in young children (younger than 4 years) and Susan Owen, RN, CDE”
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Long-term Efficacy of Insulin Pump Therapy in Children with Type 1 Diabetes Mellitus
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“…are other reports of improved glycaemic control in children using insulin pump therapy, 21 22 only a single randomised controlled trial exists, 23 which was underpowered and found at the end of follow-up (only 12 months) that no difference existed in glycaemic control between those using…”
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Self-citationSexual activity in diabetic patients treated by continuous subcutaneous insulin infusion therapy
Riveline, J. P., Franc, S., Biedzinski, M., Jollois, F.-X., Messaoudi, N., Lagarde, F., Lormeau, B., Pichard, S., Varroud-Vial, M., Deburge, A., et al. (2010) · Diabetes & Metabolism · doi:10.1016/j.diabet.2010.01.004 · Cited by 13
Metadata
- Authors
- Doyle (Boland), E. A., Weinzimer, S. A., Steffen, A. T., Ahern, J. A. H., Vincent, M., & Tamborlane, W. V.
- Affiliations
- From the Department of Pediatrics and the Children’s Clinical Research Center, Yale University School of Medicine, New Haven, Connecticut
- Yale University (US)
- Venue
- Diabetes Care
- Publisher
- American Diabetes Association
- Published
- 2004-07-01
- Volume
- 27
- Issue
- 7
- Pages
- 1554-1558
- ISSN
- 0149-5992 (ISSN-L)
- 1935-5548
- OpenAlex
- W2138976255
- Cited by
- 373
- References
- 15
- Citations by year
- 2026: 3 · 2025: 2 · 2024: 6 · 2023: 2 · 2022: 9 · 2021: 8 · 2020: 10 · 2019: 13 · 2018: 14 · 2017: 9 · 2016: 15 · 2015: 19 · 2014: 24 · 2013: 20 · 2012: 23
- FWCI
- 17.43
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Diabetes Care (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Yale University
- Novo Nordisk
- National Institutes of Health (5u01hd037251-05)
- National Center for Research Resources (RR06022)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (HD 37251)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Diabetes and associated disorders
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
- Keywords
- type 1 diabetes, insulin pump therapy, multiple daily insulin injections, insulin glargine, insulin aspart, glycemic control, HbA1c, total daily insulin dose, self-monitoring of blood glucose, pediatric diabetes, adolescents
- MeSH terms
- Insulin Glargine, Adolescent, Adult, Child, Diabetes Mellitus, Type 1, Drug Administration Schedule, Glycated Hemoglobin, Humans, Hypoglycemic Agents, Injections, Subcutaneous, Insulin, Insulin Infusion Systems, Blood Glucose Self-Monitoring, Patient Selection, Postprandial Period, Insulin, Long-Acting
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