Effect of continuous glucose monitoring on glycemic control in adults with type 1 diabetes using insulin injections the diamond randomized clinical trial

DIAMOND Study Group

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Abstract

IMPORTANCE Previous clinical trials showing the benefit of continuous glucose monitoring (CGM) in the management of type 1 diabetes predominantly have included adults using insulin pumps, even though the majority of adults with type 1 diabetes administer insulin by injection. OBJECTIVE To determine the effectiveness of CGM in adults with type 1 diabetes treated with insulin injections. DESIGN, SETTING, AND PARTICIPANTS Randomized clinical trial conducted between October 2014 and May 2016 at 24 endocrinology practices in the United States that included 158 adults with type 1 diabetes who were using multiple daily insulin injections and had hemoglobin A1c (HbA1c) levels of 7.5%to 9.9%. INTERVENTIONS Random assignment 2:1 toCGM(n = 105) or usual care (control group; n = 53). MAIN OUTCOMES AND MEASURES Primary outcome measurewas the difference in change in central-laboratory-measured HbA1c level from baseline to 24 weeks. There were 18 secondary or exploratory end points, of which 15 are reported in this article, including duration of hypoglycemia at less than 70mg/dL, measured with CGM for 7 days at 12 and 24 weeks. RESULTS Among the 158 randomized participants (mean age, 48 years [SD, 13]; 44%women; mean baseline HbA1c level, 8.6% [SD, 0.6%]; and median diabetes duration, 19 years [interquartile range, 10-31 years]), 155 (98%) completed the study. In the CGM group, 93% used CGM 6 d/wk or more in month 6. Mean HbA1c reduction from baseline was 1.1%at 12 weeks and 1.0% at 24 weeks in the CGM group and 0.5%and 0.4%, respectively, in the control group (repeated-measures model P < .001). At 24 weeks, the adjusted treatment-group difference in mean change in HbA1c level from baseline was -0.6%(95%CI, -0.8%to -0.3%; P < .001). Median duration of hypoglycemia at less than <70mg/dL was 43 min/d (IQR, 27-69) in the CGM group vs 80 min/d (IQR, 36-111) in the control group (P = .002). Severe hypoglycemia events occurred in 2 participants in each group. CONCLUSIONS AND RELEVANCE Among adults with type 1 diabetes who used multiple daily insulin injections, the use of CGM compared with usual care resulted in a greater decrease in HbA1c level during 24 weeks. Further research is needed to assess longer-term effectiveness, as well as clinical outcomes and adverse effects.

Original languageEnglish (US)
Pages (from-to)371-378
Number of pages8
JournalJAMA - Journal of the American Medical Association
Volume317
Issue number4
DOIs
StatePublished - Jan 24 2017

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Diamond
Type 1 Diabetes Mellitus
Randomized Controlled Trials
Insulin
Glucose
Hemoglobins
Injections
Hypoglycemia
Control Groups
Endocrinology
Outcome Assessment (Health Care)
Clinical Trials
Research

ASJC Scopus subject areas

  • Medicine(all)

Cite this

@article{04085260f2024da1ad78bfeb32226d2a,
title = "Effect of continuous glucose monitoring on glycemic control in adults with type 1 diabetes using insulin injections the diamond randomized clinical trial",
abstract = "IMPORTANCE Previous clinical trials showing the benefit of continuous glucose monitoring (CGM) in the management of type 1 diabetes predominantly have included adults using insulin pumps, even though the majority of adults with type 1 diabetes administer insulin by injection. OBJECTIVE To determine the effectiveness of CGM in adults with type 1 diabetes treated with insulin injections. DESIGN, SETTING, AND PARTICIPANTS Randomized clinical trial conducted between October 2014 and May 2016 at 24 endocrinology practices in the United States that included 158 adults with type 1 diabetes who were using multiple daily insulin injections and had hemoglobin A1c (HbA1c) levels of 7.5{\%}to 9.9{\%}. INTERVENTIONS Random assignment 2:1 toCGM(n = 105) or usual care (control group; n = 53). MAIN OUTCOMES AND MEASURES Primary outcome measurewas the difference in change in central-laboratory-measured HbA1c level from baseline to 24 weeks. There were 18 secondary or exploratory end points, of which 15 are reported in this article, including duration of hypoglycemia at less than 70mg/dL, measured with CGM for 7 days at 12 and 24 weeks. RESULTS Among the 158 randomized participants (mean age, 48 years [SD, 13]; 44{\%}women; mean baseline HbA1c level, 8.6{\%} [SD, 0.6{\%}]; and median diabetes duration, 19 years [interquartile range, 10-31 years]), 155 (98{\%}) completed the study. In the CGM group, 93{\%} used CGM 6 d/wk or more in month 6. Mean HbA1c reduction from baseline was 1.1{\%}at 12 weeks and 1.0{\%} at 24 weeks in the CGM group and 0.5{\%}and 0.4{\%}, respectively, in the control group (repeated-measures model P < .001). At 24 weeks, the adjusted treatment-group difference in mean change in HbA1c level from baseline was -0.6{\%}(95{\%}CI, -0.8{\%}to -0.3{\%}; P < .001). Median duration of hypoglycemia at less than <70mg/dL was 43 min/d (IQR, 27-69) in the CGM group vs 80 min/d (IQR, 36-111) in the control group (P = .002). Severe hypoglycemia events occurred in 2 participants in each group. CONCLUSIONS AND RELEVANCE Among adults with type 1 diabetes who used multiple daily insulin injections, the use of CGM compared with usual care resulted in a greater decrease in HbA1c level during 24 weeks. Further research is needed to assess longer-term effectiveness, as well as clinical outcomes and adverse effects.",
author = "{DIAMOND Study Group} and Beck, {Roy W.} and Tonya Riddlesworth and Katrina Ruedy and Andrew Ahmann and Richard Bergenstal and Stacie Haller and Craig Kollman and Davida Kruger and McGill, {Janet B.} and William Polonsky and Elena Toschi and Howard Wolpert and David Price",
year = "2017",
month = "1",
day = "24",
doi = "10.1001/jama.2016.19975",
language = "English (US)",
volume = "317",
pages = "371--378",
journal = "JAMA - Journal of the American Medical Association",
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TY - JOUR

T1 - Effect of continuous glucose monitoring on glycemic control in adults with type 1 diabetes using insulin injections the diamond randomized clinical trial

AU - DIAMOND Study Group

AU - Beck, Roy W.

AU - Riddlesworth, Tonya

AU - Ruedy, Katrina

AU - Ahmann, Andrew

AU - Bergenstal, Richard

AU - Haller, Stacie

AU - Kollman, Craig

AU - Kruger, Davida

AU - McGill, Janet B.

AU - Polonsky, William

AU - Toschi, Elena

AU - Wolpert, Howard

AU - Price, David

PY - 2017/1/24

Y1 - 2017/1/24

N2 - IMPORTANCE Previous clinical trials showing the benefit of continuous glucose monitoring (CGM) in the management of type 1 diabetes predominantly have included adults using insulin pumps, even though the majority of adults with type 1 diabetes administer insulin by injection. OBJECTIVE To determine the effectiveness of CGM in adults with type 1 diabetes treated with insulin injections. DESIGN, SETTING, AND PARTICIPANTS Randomized clinical trial conducted between October 2014 and May 2016 at 24 endocrinology practices in the United States that included 158 adults with type 1 diabetes who were using multiple daily insulin injections and had hemoglobin A1c (HbA1c) levels of 7.5%to 9.9%. INTERVENTIONS Random assignment 2:1 toCGM(n = 105) or usual care (control group; n = 53). MAIN OUTCOMES AND MEASURES Primary outcome measurewas the difference in change in central-laboratory-measured HbA1c level from baseline to 24 weeks. There were 18 secondary or exploratory end points, of which 15 are reported in this article, including duration of hypoglycemia at less than 70mg/dL, measured with CGM for 7 days at 12 and 24 weeks. RESULTS Among the 158 randomized participants (mean age, 48 years [SD, 13]; 44%women; mean baseline HbA1c level, 8.6% [SD, 0.6%]; and median diabetes duration, 19 years [interquartile range, 10-31 years]), 155 (98%) completed the study. In the CGM group, 93% used CGM 6 d/wk or more in month 6. Mean HbA1c reduction from baseline was 1.1%at 12 weeks and 1.0% at 24 weeks in the CGM group and 0.5%and 0.4%, respectively, in the control group (repeated-measures model P < .001). At 24 weeks, the adjusted treatment-group difference in mean change in HbA1c level from baseline was -0.6%(95%CI, -0.8%to -0.3%; P < .001). Median duration of hypoglycemia at less than <70mg/dL was 43 min/d (IQR, 27-69) in the CGM group vs 80 min/d (IQR, 36-111) in the control group (P = .002). Severe hypoglycemia events occurred in 2 participants in each group. CONCLUSIONS AND RELEVANCE Among adults with type 1 diabetes who used multiple daily insulin injections, the use of CGM compared with usual care resulted in a greater decrease in HbA1c level during 24 weeks. Further research is needed to assess longer-term effectiveness, as well as clinical outcomes and adverse effects.

AB - IMPORTANCE Previous clinical trials showing the benefit of continuous glucose monitoring (CGM) in the management of type 1 diabetes predominantly have included adults using insulin pumps, even though the majority of adults with type 1 diabetes administer insulin by injection. OBJECTIVE To determine the effectiveness of CGM in adults with type 1 diabetes treated with insulin injections. DESIGN, SETTING, AND PARTICIPANTS Randomized clinical trial conducted between October 2014 and May 2016 at 24 endocrinology practices in the United States that included 158 adults with type 1 diabetes who were using multiple daily insulin injections and had hemoglobin A1c (HbA1c) levels of 7.5%to 9.9%. INTERVENTIONS Random assignment 2:1 toCGM(n = 105) or usual care (control group; n = 53). MAIN OUTCOMES AND MEASURES Primary outcome measurewas the difference in change in central-laboratory-measured HbA1c level from baseline to 24 weeks. There were 18 secondary or exploratory end points, of which 15 are reported in this article, including duration of hypoglycemia at less than 70mg/dL, measured with CGM for 7 days at 12 and 24 weeks. RESULTS Among the 158 randomized participants (mean age, 48 years [SD, 13]; 44%women; mean baseline HbA1c level, 8.6% [SD, 0.6%]; and median diabetes duration, 19 years [interquartile range, 10-31 years]), 155 (98%) completed the study. In the CGM group, 93% used CGM 6 d/wk or more in month 6. Mean HbA1c reduction from baseline was 1.1%at 12 weeks and 1.0% at 24 weeks in the CGM group and 0.5%and 0.4%, respectively, in the control group (repeated-measures model P < .001). At 24 weeks, the adjusted treatment-group difference in mean change in HbA1c level from baseline was -0.6%(95%CI, -0.8%to -0.3%; P < .001). Median duration of hypoglycemia at less than <70mg/dL was 43 min/d (IQR, 27-69) in the CGM group vs 80 min/d (IQR, 36-111) in the control group (P = .002). Severe hypoglycemia events occurred in 2 participants in each group. CONCLUSIONS AND RELEVANCE Among adults with type 1 diabetes who used multiple daily insulin injections, the use of CGM compared with usual care resulted in a greater decrease in HbA1c level during 24 weeks. Further research is needed to assess longer-term effectiveness, as well as clinical outcomes and adverse effects.

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U2 - 10.1001/jama.2016.19975

DO - 10.1001/jama.2016.19975

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