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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Randomized controlled trials comparing insulin pumps and multiple daily injections with rapid-acting insulin analogs demonstrated a modest improvement in A1C levels in participants on insulin pump therapy.
“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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BackgroundInfluential14. Children and Adolescents: Standards of Medical Care in Diabetes—2022
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ElSayed, N. A., Aleppo, G., Aroda, V. R., Bannuru, R. R., Brown, F. M., Bruemmer, D., Collins, B. S., Hilliard, M. E., Isaacs, D., Johnson, E. L., et al. (2023) · Diabetes Care · doi:10.2337/dc23-s007 · Cited by 301 · see citing works
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“There is also evidence that CSII may reduce DKA risk (109,114) and diabetes complications, in particular, retinopathy and peripheral neuropathy in youth, compared with MDI (62).”
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“In contrast, Weintrob et al. (22) found a significantly higher BMI SDS in the group treated with MDI compared with patients treated with CSII (one RCT, n ¼ 23, mean difference 0.35 0.83 vs. 0.37 0.12, p ¼ 0.012).”
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“Data exist to support the use of real-time CGM in adults and children, both those on multiple daily injections (MDI) and those on continuous subcutaneous insulin infusion (CSII).”
BackgroundInfluential13. Children and Adolescents: Standards of Medical Care in Diabetes—2019
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ISPAD Clinical Practice Consensus Guidelines 2018: diabetes technologies
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“Randomized controlled trials (RCTs) assessing the use of insulin pumps have yielded conflicting results, with some showing improvement of glycemic control with use of the technology.(33,34) Yet, the RCT studies that have not shown a lowering of HbA1c have highlighted the endorsement of pump therapy as patients randomi…”
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“studies have shown CSII to be more effective in lowering HbA1c than injection therapy (35,36).”
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“However, randomized controlled trials (RCTs) comparing CSII and MDI with insulin analogs demonstrate a modest improvement in A1C in participants onCSII (25,26).”
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“with some showing improvement of glycemia with use of the technology.(65,66) Even in RCTs where no lowering of HbA1c was observed, continued use of the devices after the end of the study, higher reports of treatment satisfaction,(72) and decreased diabetes-related worry highlight that benefits extend beyond glycemic m…”
MethodPsychosocial problems in adolescents with type 1 diabetes mellitus
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“(12) but in contrast to two other studies (10,18).”
BackgroundResultInsulin treatment in children and adolescents with diabetes
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Grey, M. J., Whittemore, R., Jaser, S. S., Ambrosino, J. M., Lindemann, E., Liberti, L. S., Northrup, V. S., & Dziura, J. D. (2009) · Research in Nursing & Health · doi:10.1002/nur.20336 · Cited by 124 · see citing works
“Although previous research has demonstrated better metabolic control and QOL in children treated with a pump vs. injections (Doyle et al., 2004; Hilliard, Goeke-Morey, Cogen, Henderson, & Streisand, 2008; Nimri et al., 2006), more information is needed on the impact of treatment modality on family…”
Bolli, G. B., Kerr, D., Thomas, R., Torlone, E., Sola-Gazagnes, A., Vitacolonna, E., Selam, J. L., & Home, P. D. (2009) · Diabetes Care · doi:10.2337/dc08-1874 · Cited by 119 · see citing works
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“Some of the available trials found an improvement of health-related quality of life associated with CSII [9, 10, 17], but this result was not confirmed by other studies [11, 12, 18].”
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Coping and Psychosocial Adjustment in Mothers of Young Children With Type 1 Diabetes
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“These low levels may be related to the high percentage of the children using insulin pumps (68%), which has been associated with lower blood glucose levels than insulin injections (Doyle et al., 2004).”
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Insulin Detection Using a Corona Phase Molecular Recognition Site on Single-Walled Carbon Nanotubes
Bisker, G., Bakh, N. A., Lee, M. A., Ahn, J., Park, M., O'Connell, E. B., Iverson, N. M., & Strano, M. S. (2018) · ACS Sensors · doi:10.1021/acssensors.7b00788 · Cited by 106 · see citing works
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“As new long-acting insulin analogues (glargine, detemir) are able to provide a better basal insulin delivery as compared to Neutral Protamine Hagedorn (NPH) insulin and thus may be considered as an alternative to CSII [21,22], recent, albeit scarce, data concerning allergy reactions to these analogues or attempts of i…”
BackgroundBruttomesso, D., Costa, S., & Baritussio, A. (2009) · Diabetes/Metabolism Research and Reviews · doi:10.1002/dmrr.931 · Cited by 98 · see citing works
“[28] found lower levels of HbA1c during CSII.”
BackgroundHypoglycemia and ketoacidosis with insulin pump therapy in children and adolescents
Hanås, R., & Ludvigsson, J. (2006) · Pediatric Diabetes · doi:10.1111/j.1399-543x.2006.00169.x · Cited by 91 · see citing works
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Insulin Therapy in Children and Adolescents with Type 1 Diabetes
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“Similarly, pump therapy is associated with lower rates of hypoglycemia when compared with MDI regimens using NPH [69, 70] and glargine [71] as the long-acting insulin.”
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Management of diabetes mellitus: is the pump mightier than the pen?
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The impact of modifiable family factors on glycemic control among youth with type 1 diabetes
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“[60] in a study recruiting children showed the superiority of CSII on HbA1C levels after 16 weeks, with significantly lower average insulin use.”
BackgroundInsulin Pump Therapy Guidelines for Successful Outcomes
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“One trial (6) in young people showed marginal superiority of CSII in A1C reduction.”
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MethodMicrodosing for drug delivery application—A review
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“Only one 16-week study [39] directly compared insulin glargine and aspart.”
BackgroundHypoglycemia in Type 1 Diabetes
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“Therefore, the ID is significantly lower in CSII than in MIT ( 50 ) except for children at preschool age.”
BackgroundpI-shifted insulin analogs with extended in vivo time action and favorable receptor selectivity
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“Similarly, a pediatric study also demonstrated that continuous subcutaneous injections of insulin glargine reduced HbA1C levels and controlled pre-meal glucose levels better than multiple daily injections.(99) Optimal timing of treatment for T2DM is also variable and can depend on drug and treatment schedule based on…”
Background
- 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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