1Graduate School, Yonsei University College of Medicine, Seoul, Korea
2Division of Endocrinology and Metabolism, Department of Internal Medicine, CHA Gangnam Medical Center, CHA University School of Medicine, Seoul, Korea
3Department of Medical Device Engineering and Management, Yonsei University Graduate School, Seoul, Korea
4Department of Medical Science, Soonchunhyang University Graduate School, Asan, Korea
5Diabetes Center, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
6Division of Endocrinology and Metabolism, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea
7Department of Health Administration and Management, College of Medical Science, Soonchunhyang University, Asan, Korea
8Department of Preventive Medicine, Yonsei University College of Medicine, Seoul, Korea
Copyright © 2023 Korean Diabetes Association
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
CONFLICTS OF INTEREST
No potential conflict of interest relevant to this article was reported.
AUTHOR CONTRIBUTIONS
Conception or design: S.L., K.Y.K., S.G.L., E.S.K.
Acquisition, analysis, or interpretation of data: S.L., K.Y.K., J.E.K., M.L.
Drafting the work or revising: S.L., K.Y.K., Y.H., M.I.H.
Final approval of the manuscript: S.G.L., E.S.K.
FUNDING
This study was supported by a Severance Hospital Research fund for Clinical excellence (SHRC) (C-2021-0007).
Characteristic | Control (n=212) | Intervention (n=196) | P value |
---|---|---|---|
Age, yr | 45.4±16.0 | 43.3±15.3 | 0.173 |
Sex | 0.124 | ||
Male | 101 (47.6) | 73 (37.2) | |
Female | 111 (52.4) | 123 (62.8) | |
DM duration, yr | 15.5 (8.5–24.5) | 14.0 (7.0–23.0) | 0.136 |
BMI, kg/m2 | 22.5 (20.7–24.6) | 22.0 (20.2–24.7) | 0.219 |
FBG, mg/dL | 149.3±63.3 | 158.6±75.8 | 0.183 |
HbA1c, % | 8.1±1.6 | 8.6±1.9 | 0.008 |
GA, % | 24.2±6.3 | 25.7±8.4 | 0.087 |
GA/HbA1c ratio | 2.9 (2.6–3.2) | 3.0 (2.7–3.3) | 0.783 |
eGFR, mL/min/1.73 m2 | 89.7 (71.6–103.5) | 88.6 (74.0–102.3) | 0.990 |
Uric acid, mg/dL | 4.4 (4.1–4.5) | 4.4 (3.6–5.3) | 0.757 |
Albumin, g/dL | 4.3 (4.1–4.5) | 4.3 (4.1–4.5) | 0.197 |
AST, IU/L | 19.0 (15.0–24.0) | 19.0 (16.0–24.0) | 0.583 |
ALT, IU/L | 16.0 (12.0–23.0) | 16.0 (12.0–23.0) | 0.736 |
γ-GT, IU/L | 19.5 (15.0–33.0) | 19.5 (13.5–27.5) | 0.395 |
TC, mg/dL | 171.0 (148.5–191.0) | 171.5 (153.5–196.0) | 0.330 |
TG, mg/dL | 86.0 (61.5–109.0) | 85.0 (61.5–115.5) | 0.779 |
HDL-C, mg/dL | 60.0 (47.0–72.0) | 61.0 (51.0–72.0) | 0.396 |
LDL-C, mg/dL | 90.0 (67.9–106.6) | 89.8 (71.2–112.1) | 0.410 |
Insulin treatment | |||
MDI | 175 (82.5) | 176 (89.8) | 0.108 |
Pre-mixed | 26 (12.3) | 14 (7.1) | |
Insulin pump | 11 (5.2) | 6 (3.1) | |
CGM users | |||
Yes | 31 (14.6) | 71 (36.2) | <0.001 |
No | 181 (85.4) | 125 (63.8) | |
Severe hypoglycemiaa | 7 (3.3) | 4 (3.2) | 1.000 |
Values are presented as mean±standard deviation, number (%), or median (interquartile range).
DM, diabetes mellitus; BMI, body mass index; FBG, fasting blood glucose; HbA1c, glycosylated hemoglobin; GA, glycoalbumin; eGFR, estimated glomerular filtration rate; AST, aspartate aminotransferase; ALT, alanine aminotransferase; γ-GT, gamma-glutamyl transpeptidase; TC, total cholesterol; TG, triglyceride; HDL-C, high-density lipoprotein cholesterol; LDL-C, low-density lipoprotein cholesterol; MDI, multiple daily injection; CGM, continuous glucose monitoring system.
a This category included any episode of hypoglycemia that require emergency department visits or hospitalizations.
Outcomes |
EMM (95% CI) |
P valuea | |
---|---|---|---|
Control group | Intervention group | ||
HbA1c, % | |||
3 months | –0.15 (–0.22 to –0.08) | –0.29 (–0.37 to 0.21) | 0.218 |
6 months | –0.22 (–0.30 to –0.15) | –0.39 (–0.47 to 0.31) | 0.170 |
9 months | –0.23 (–0.32 to –0.15) | –0.57 (–0.66 to –0.49) | 0.008 |
GA, % | |||
3 months | –0.40 (–0.79 to –0.01) | –1.12 (–1.49 to –0.75) | 0.207 |
6 months | 0.05 (–0.37 to 0.48) | –2.04 (–2.43 to –1.65) | <0.001 |
9 months | –0.39 (–0.84 to 0.08) | –3.20 (–3.60 to –2.79) | <0.001 |
FBG, mg/dL | |||
3 months | –2.60 (–9.17 to 3.97) | –10.44 (–17.28 to –3.60) | 0.345 |
6 months | –1.41 (–8.74 to 5.92) | –8.58 (–16.03 to –1.13) | 0.485 |
9 months | –10.59 (–19.53 to –1.65) | –7.60 (–19.07 to 3.87) | 0.810 |
GA/HbA1c ratio | |||
3 months | 0.02 (–0.02 to 0.06) | –0.03 (–0.07 to 0.01) | 0.272 |
6 months | 0.06 (0.02 to 0.10) | –0.05 (–0.09 to –0.01) | 0.037 |
9 months | 0.04 (–0.01 to 0.09) | –0.13 (–0.17 to –0.09) | 0.008 |
Characteristic | Control (n=212) | Intervention (n=196) | P value |
---|---|---|---|
Age, yr | 45.4±16.0 | 43.3±15.3 | 0.173 |
Sex | 0.124 | ||
Male | 101 (47.6) | 73 (37.2) | |
Female | 111 (52.4) | 123 (62.8) | |
DM duration, yr | 15.5 (8.5–24.5) | 14.0 (7.0–23.0) | 0.136 |
BMI, kg/m2 | 22.5 (20.7–24.6) | 22.0 (20.2–24.7) | 0.219 |
FBG, mg/dL | 149.3±63.3 | 158.6±75.8 | 0.183 |
HbA1c, % | 8.1±1.6 | 8.6±1.9 | 0.008 |
GA, % | 24.2±6.3 | 25.7±8.4 | 0.087 |
GA/HbA1c ratio | 2.9 (2.6–3.2) | 3.0 (2.7–3.3) | 0.783 |
eGFR, mL/min/1.73 m2 | 89.7 (71.6–103.5) | 88.6 (74.0–102.3) | 0.990 |
Uric acid, mg/dL | 4.4 (4.1–4.5) | 4.4 (3.6–5.3) | 0.757 |
Albumin, g/dL | 4.3 (4.1–4.5) | 4.3 (4.1–4.5) | 0.197 |
AST, IU/L | 19.0 (15.0–24.0) | 19.0 (16.0–24.0) | 0.583 |
ALT, IU/L | 16.0 (12.0–23.0) | 16.0 (12.0–23.0) | 0.736 |
γ-GT, IU/L | 19.5 (15.0–33.0) | 19.5 (13.5–27.5) | 0.395 |
TC, mg/dL | 171.0 (148.5–191.0) | 171.5 (153.5–196.0) | 0.330 |
TG, mg/dL | 86.0 (61.5–109.0) | 85.0 (61.5–115.5) | 0.779 |
HDL-C, mg/dL | 60.0 (47.0–72.0) | 61.0 (51.0–72.0) | 0.396 |
LDL-C, mg/dL | 90.0 (67.9–106.6) | 89.8 (71.2–112.1) | 0.410 |
Insulin treatment | |||
MDI | 175 (82.5) | 176 (89.8) | 0.108 |
Pre-mixed | 26 (12.3) | 14 (7.1) | |
Insulin pump | 11 (5.2) | 6 (3.1) | |
CGM users | |||
Yes | 31 (14.6) | 71 (36.2) | <0.001 |
No | 181 (85.4) | 125 (63.8) | |
Severe hypoglycemia |
7 (3.3) | 4 (3.2) | 1.000 |
Outcomes | EMM (95% CI) |
P value |
|
---|---|---|---|
Control group | Intervention group | ||
HbA1c, % | |||
3 months | –0.15 (–0.22 to –0.08) | –0.29 (–0.37 to 0.21) | 0.218 |
6 months | –0.22 (–0.30 to –0.15) | –0.39 (–0.47 to 0.31) | 0.170 |
9 months | –0.23 (–0.32 to –0.15) | –0.57 (–0.66 to –0.49) | 0.008 |
GA, % | |||
3 months | –0.40 (–0.79 to –0.01) | –1.12 (–1.49 to –0.75) | 0.207 |
6 months | 0.05 (–0.37 to 0.48) | –2.04 (–2.43 to –1.65) | <0.001 |
9 months | –0.39 (–0.84 to 0.08) | –3.20 (–3.60 to –2.79) | <0.001 |
FBG, mg/dL | |||
3 months | –2.60 (–9.17 to 3.97) | –10.44 (–17.28 to –3.60) | 0.345 |
6 months | –1.41 (–8.74 to 5.92) | –8.58 (–16.03 to –1.13) | 0.485 |
9 months | –10.59 (–19.53 to –1.65) | –7.60 (–19.07 to 3.87) | 0.810 |
GA/HbA1c ratio | |||
3 months | 0.02 (–0.02 to 0.06) | –0.03 (–0.07 to 0.01) | 0.272 |
6 months | 0.06 (0.02 to 0.10) | –0.05 (–0.09 to –0.01) | 0.037 |
9 months | 0.04 (–0.01 to 0.09) | –0.13 (–0.17 to –0.09) | 0.008 |
Characteristic | Overall satisfaction | Effectiveness | Behavioral intention |
---|---|---|---|
Age, yr | |||
<30 | 3.29±0.60 | 3.29±0.68 | 3.43±0.69 |
30–49 | 3.43±0.73 | 3.49±0.63 | 3.52±0.79 |
≥50 | 3.57±0.60 | 3.46±0.69 | 3.57±0.60 |
Sex | |||
Male | 3.46±0.71 | 3.47±0.60 | 3.58±0.76 |
Female | 3.39±0.61 | 3.36±0.70 | 3.46±0.66 |
Education level | |||
Middle school | 3.29±0.72 | 3.20±0.81 | 3.52±0.68 |
High school | 3.38±0.51 | 3.42±0.49 | 3.54±0.66 |
University or higher | 3.50±0.65 | 3.51±0.62 | 3.47±0.73 |
Income/month, Korean Won | |||
<2,000,000 | 3.50±0.52 | 3.36±0.58 | 3.75±0.45 |
2,000,000–4,990,000 | 3.37±0.68 | 3.56±0.58 | 3.68±0.48 |
≥5,000,000 | 3.32±0.72 | 3.20±0.77 | 3.41±0.73 |
Subjective health status | |||
Healthy | 3.27±0.53 | 3.22±0.65 | 3.58±0.58 |
Unhealthy | 3.50±0.69 | 3.50±0.66 | 3.46±0.75 |
Total | 3.42±0.65 | 3.40±0.66 | 3.50±0.69 |
Values are presented as mean±standard deviation, number (%), or median (interquartile range). DM, diabetes mellitus; BMI, body mass index; FBG, fasting blood glucose; HbA1c, glycosylated hemoglobin; GA, glycoalbumin; eGFR, estimated glomerular filtration rate; AST, aspartate aminotransferase; ALT, alanine aminotransferase; γ-GT, gamma-glutamyl transpeptidase; TC, total cholesterol; TG, triglyceride; HDL-C, high-density lipoprotein cholesterol; LDL-C, low-density lipoprotein cholesterol; MDI, multiple daily injection; CGM, continuous glucose monitoring system. This category included any episode of hypoglycemia that require emergency department visits or hospitalizations.
EMM changes from baseline to each follow-up were analyzed after adjusting for age, sex, and body mass index. EMM, estimated marginal mean; CI, confidence interval; HbA1c, glycosylated hemoglobin; GA, glycoalbumin; FBG, fasting blood glucose.
Values are presented as mean±standard deviation.