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Effect of Continuous Glucose Monitoring on Glycemic Control in Adolescents and Young Adults With Type 1 Diabetes: A Randomized Clinical Trial

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Laffel, Lori M., Kanapka, Lauren G., Beck, Roy W., Bergamo, Katherine, Clements, Mark A., Criego, Amy, DeSalvo, Daniel J., Goland, Robin +13 more·2020·JAMA

Abstract

Importance: Adolescents and young adults with type 1 diabetes exhibit the worst glycemic control among individuals with type 1 diabetes across the lifespan. Although continuous glucose monitoring (CGM) has been shown to improve glycemic control in adults, its benefit in adolescents and young adults has not been demonstrated. Objective: To determine the effect of CGM on glycemic control in adolescents and young adults with type 1 diabetes. Design, Setting, and Participants: Randomized clinical trial conducted between January 2018 and May 2019 at 14 endocrinology practices in the US including 153 individuals aged 14 to 24 years with type 1 diabetes and screening hemoglobin A1c (HbA1c) of 7.5% to 10.9%. Interventions: Participants were randomized 1:1 to undergo CGM (CGM group; n = 74) or usual care using a blood glucose meter for glucose monitoring (blood glucose monitoring [BGM] group; n = 79). Main Outcomes and Measures: The primary outcome was change in HbA1c from baseline to 26 weeks. There were 20 secondary outcomes, including additional HbA1c outcomes, CGM glucose metrics, and patient-reported outcomes with adjustment for multiple comparisons to control for the false discovery rate. Results: Among the 153 participants (mean [SD] age, 17 [3] years; 76 [50%] were female; mean [SD] diabetes duration, 9 [5] years), 142 (93%) completed the study. In the CGM group, 68% of participants used CGM at least 5 days per week in month 6. Mean HbA1c was 8.9% at baseline and 8.5% at 26 weeks in the CGM group and 8.9% at both baseline and 26 weeks in the BGM group (adjusted between-group difference, -0.37% [95% CI, -0.66% to -0.08%]; P = .01). Of 20 prespecified secondary outcomes, there were statistically significant differences in 3 of 7 binary HbA1c outcomes, 8 of 9 CGM metrics, and 1 of 4 patient-reported outcomes. The most commonly reported adverse events in the CGM and BGM groups were severe hypoglycemia (3 participants with an event in the CGM group and 2 in the BGM group), hyperglycemia/ketosis (1 participant with an event in CGM group and 4 in the BGM group), and diabetic ketoacidosis (3 participants with an event in the CGM group and 1 in the BGM group). Conclusions and Relevance: Among adolescents and young adults with type 1 diabetes, continuous glucose monitoring compared with standard blood glucose monitoring resulted in a small but statistically significant improvement in glycemic control over 26 weeks. Further research is needed to understand the clinical importance of the findings. Trial Registration: ClinicalTrials.gov Identifier: NCT03263494.

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  • The clinical efficacy of CGM has been demonstrated in numerous retrospective studies and RCTs of people with T1D regardless of insulin delivery method.

    “The clinical efficacy of CGM has been demonstrated in numerous retrospective studies and RCTs of individuals with T1D regardless of insulin delivery method.156–161”

    From American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. (2022) · cites this paper as [158]

    The Participants section includes adolescents and young adults with type 1 diabetes using either an insulin pump or multiple daily injections. The Primary Outcome section reports improved HbA1c with CGM versus blood glucose monitoring and no significant interaction by insulin delivery method. This source is one RCT in people aged 14–24; it does not itself establish efficacy across all people with type 1 diabetes or document numerous retrospective studies. (LLM, conf=0.85)

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  • Adding continuous glucose monitoring to either multiple daily injections or continuous subcutaneous insulin infusion substantially improves A1C, time in range, hypoglycemic events, quality of life, and patient satisfaction, with better results when continuous subcutaneous insulin infusion is combined with continuous glucose monitoring or integrated into automated insulin delivery systems.

    “Regardless of the insulin delivery method (MDI vs CSII), glycemic control metrics, including A1C and CGM TIR, hypoglycemic events, QoL, and patient satisfaction are substantially improved when MDI or CSII is augmented with CGM, with better results when CSII is combined with CGM or integrated into AID systems, compared with using CGM.158,160,1129–1131”

    From American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. (2022) · cites this paper as [158]

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  • In children, adolescents, and adults with type 1 diabetes, real-time continuous glucose monitoring consistently improves glycaemic metrics compared with capillary blood glucose monitoring.

    “Compared to capillary blood glucose monitoring, real-time continuous glucose monitoring has been shown to consistently improve glycaemic metrics in children,14 adolescents15 and adults,16 including older adults,17 with type 1 diabetes.”

    From Blood glucose monitoring devices: current considerations (2023) · cites this paper as [15]

  • A subsequent RCT specifically targeting adolescents and young adults, which included considerable education and support, showed that those randomized to rt-CGM had significantly reduced HbA 1c after 6 months compared with those randomized to BGM.

    “A subsequent RCT specifically targeting adolescents and young adults, which included considerable education and support, showed that those randomized to rt-CGM had significantly reduced HbA 1c after 6 months compared with those randomized to BGM (175).”
  • A1C reduction was seen in adolescents and young adults with type 1 diabetes using rtCGM.

    “Similarly, A1C level reduction was seen in adolescents and young adults with type 1 diabetes using rtCGM (48).”

    From 7. Diabetes Technology: Standards of Care in Diabetes—2025 (2025) · cites this paper as [48]

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Authors
Laffel, L. M., Kanapka, L. G., Beck, R. W., Bergamo, K., Clements, M. A., Criego, A., DeSalvo, D. J., Goland, R., Hood, K., Liljenquist, D., Messer, L. H., Monzavi, R., Mouse, T. J., Prahalad, P., Sherr, J., Simmons, J. H., Wadwa, R. P., Weinstock, R. S., Willi, S. M., Miller, K. M., & CGM Intervention in Teens and Young Adults with T1D (CITY) Study Group
Affiliations
  • Joslin Diabetes Center (US)
  • Jaeb Center for Health Research (US)
  • University of North Carolina at Chapel Hill (US)
  • Children's Mercy Hospital (US)
  • HealthPartners (US)
  • Baylor College of Medicine (US)
  • Columbia University (US)
  • Stanford University (US)
  • Rocky Mountain Diabetes and Osteoporosis Center (US)
  • Barbara Davis Center for Childhood Diabetes, Aurora, Colorado
  • Children's Hospital Los Angeles (US)
  • Yale University (US)
  • Vanderbilt University Medical Center (US)
  • SUNY Upstate Medical University (US)
  • Children's Hospital of Philadelphia (US)
Corresponding author
Miller, Kellee M.
Venue
JAMA
Published
2020-06-16
Volume
323
Issue
23
Pages
2388
ISSN
  • 0002-9955 (ISSN-L)
  • 0098-7484
OpenAlex
W3035569864
Cited by
443
References
15
Citations by year
2026: 60 · 2025: 78 · 2024: 79 · 2023: 77 · 2022: 79 · 2021: 58 · 2020: 12
FWCI
42.61
Type
journal article
Language
en
Open access
Locations
  • JAMA (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
Funders
  • National Institutes of Health (UL1TR001863)
  • National Institute of Diabetes and Digestive and Kidney Diseases (P30DK036836, P30DK045735)
  • National Center for Advancing Translational Sciences
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, glycemic control, adolescents, young adults, HbA1c, blood glucose meters, hypoglycemia, patient-reported outcomes, diabetes self-management, glycemic variability, HbA1c variability
MeSH terms
Adolescent, Blood Glucose, Diabetes Mellitus, Type 1, Female, Glycated Hemoglobin, Humans, Hyperglycemia, Hypoglycemia, Hypoglycemic Agents, Male, Blood Glucose Self-Monitoring, Diabetic Ketoacidosis, Monitoring, Ambulatory, Young Adult, Mobile Applications

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