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Diabetes Care. 2019 Sep 17. pii: dc190888. doi: 10.2337/dc19-0888. [Epub ahead of print]

Glycemic Outcomes in Adults With T1D Are Impacted More by Continuous Glucose Monitoring Than by Insulin Delivery Method: 3 Years of Follow-Up From the COMISAIR Study.

Author information

1
3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University, Prague, Czech Republic.
2
Department of Paediatrics, 2nd Faculty of Medicine, Charles University, Prague, Czech Republic.
3
Grunberger Diabetes Institute, Department of Internal Medicine and Center for Molecular Medicine & Genetics, Wayne State University School of Medicine, Bloomfield Hills, MI.
4
Department of Internal Medicine, William Beaumont School of Medicine, Oakland University, Rochester, MI.
5
Visiting Professor, 1st Faculty of Medicine Charles University, Prague, Czech Republic.
6
CGParkin Communications, Inc., Henderson, NV jan.soupal@seznam.cz.

Abstract

OBJECTIVE:

This study assessed the clinical impact of four treatment strategies in adults with type 1 diabetes (T1D): real-time continuous glucose monitoring (rtCGM) with multiple daily insulin injections (rtCGM+MDI), rtCGM with continuous subcutaneous insulin infusion (rtCGM+CSII), self-monitoring of blood glucose with MDI (SMBG+MDI), and SMBG with CSII (SMBG+CSII).

RESEARCH DESIGN AND METHODS:

This 3-year, nonrandomized, prospective, real-world, clinical trial followed 94 participants with T1D (rtCGM+MDI, n = 22; rtCGM+CSII, n = 26; SMBG+MDI, n = 21; SMBG+CSII, n = 25). The main end points were changes in A1C, time in range (70-180 mg/dL [3.9-10 mmol/L]), time below range (<70 mg/dL [<3.9 mmol/L]), glycemic variability, and incidence of hypoglycemia.

RESULTS:

At 3 years, the rtCGM groups (rtCGM+MDI and rtCGM+CSII) had significantly lower A1C (7.0% [53 mmol/mol], P = 0.0002, and 6.9% [52 mmol/mol], P < 0.0001, respectively), compared with the SMBG+CSII and SMBG+MDI groups (7.7% [61 mmol/mol], P = 0.3574, and 8.0% [64 mmol/mol], P = 1.000, respectively), with no significant difference between the rtCGM groups. Significant improvements in percentage of time in range were observed in the rtCGM subgroups (rtCGM+MDI, 48.7-69.0%, P < 0.0001; and rtCGM+CSII, 50.9-72.3%, P < 0.0001) and in the SMBG+CSII group (50.6-57.8%, P = 0.0114). Significant reductions in time below range were found only in the rtCGM subgroups (rtCGM+MDI, 9.4-5.5%, P = 0.0387; and rtCGM+CSII, 9.0-5.3%, P = 0.0235, respectively). Seven severe hypoglycemia episodes occurred: SMBG groups, n = 5; sensor-augmented insulin regimens groups, n = 2.

CONCLUSIONS:

rtCGM was superior to SMBG in reducing A1C, hypoglycemia, and other end points in individuals with T1D regardless of their insulin delivery method. rtCGM+MDI can be considered an equivalent but lower-cost alternative to sensor-augmented insulin pump therapy and superior to treatment with SMBG+MDI or SMBG+CSII therapy.

PMID:
31530663
DOI:
10.2337/dc19-0888

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