Effect of initiating use of an insulin pump in adults with type 1 diabetes using multiple daily insulin injections and continuous glucose monitoring (DIAMOND)

a multicentre, randomised controlled trial

DIAMOND Study Group

Research output: Contribution to journalArticle

28 Citations (Scopus)

Abstract

Background The benefit of initiation of insulin pump therapy (continuous subcutaneous insulin infusion; CSII) in patients with type 1 diabetes using continuous glucose monitoring (CGM) has not been studied. We aimed to assess glycaemic outcomes when switching from multiple daily injections (MDI) to CSII in adults with type 1 diabetes using CGM. Methods In this multicentre, randomised controlled trial, 75 adults with type 1 diabetes in the CGM group of the DIAMOND trial were randomly assigned via the study website using a computer-generated sequence to continue MDI or switch to CSII, with continuation of CGM, for 28 weeks. The primary outcome was CGM-measured time in the glucose concentration range of 70–180 mg/dL (3·9–10·0 mmol/L). This study is registered with ClinicalTrials.gov, number NCT02282397. Findings Between April 14, 2015, and May 5, 2016, 37 participants were randomly assigned to the CGM plus CSII group and 38 participants were randomly assigned to the CGM plus MDI group. The study was completed by 36 (97%) of 37 participants in the CGM plus CSII group and 35 (92%) of 38 participants in the CGM plus MDI group. Mean CGM use was 6·7 days per week (SD 0·8) in the CGM plus CSII group and 6·9 days per week (0·3) in the CGM plus MDI group (p=0·86). No participants in the CGM plus CSII group who completed the trial discontinued CSII. Over the follow-up period, mean time in the glucose concentration range of 70–180 mg/dL (3·9–10·0 mmol/L) was 791 min per day (SD 157) in the CGM plus CSII group and 741 min per day (225) in the CGM plus MDI group (adjusted mean treatment group difference: 83 min, 95% CI 17–149; p=0·01). Participants in the CGM plus CSII group had a greater reduction in CGM-measured mean glucose (p=0·005) and hyperglycaemia (on four metrics: p=0·007 for >180 mg/dL [>10·0 mmol/L], p=0·02 for >250 mg/dL [>13·9 mmol/L], p=0·04 for >300 mg/dL [>16·6 mmol/L], and p=0·02 for the area under the curve for 180 mg/dL [10·0 mmol/L]), but also an increase in CGM-measured hypoglycaemia (p=0·0001 for <70 mg/dL [<3·9 mmol/L], p=0·0002 for <60 mg/dL [<3·3 mmol/L], p=0·0009 for <50 mg/dL [<2·8 mmol/L], p=0·0002 for the area over the curve for 70 mg/dL [3·9 mmol/L]). Mean HbA1c change from baseline to 28 weeks was 0·3% (SD 0·9; 3·3 mmol/mol [SD 9·8]) in the CGM plus CSII group and 0·1% (0·4; 1·1 mmol/mol [4·4]) in the CGM plus MDI group (p=0·32). Severe hypoglycaemia occurred in one participant in the CGM plus MDI group, and diabetic ketoacidosis and severe hyperglycaemia occurred in one participant each in the CGM plus CSII group. Interpretation Our findings show that glycaemic control measured by time in the glucose range of 70–180 mg/dL (3·9–10·0 mmol/L) is improved by initiation of CSII in adults with type 1 diabetes. However, biochemical hypoglycaemia also was increased in the study, which will be important to consider when incorporating these results into clinical practice. Funding Dexcom.

Original languageEnglish (US)
Pages (from-to)700-708
Number of pages9
JournalThe Lancet Diabetes and Endocrinology
Volume5
Issue number9
DOIs
StatePublished - Sep 1 2017

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Type 1 Diabetes Mellitus
Randomized Controlled Trials
Insulin
Glucose
Injections
Hypoglycemia
Hyperglycemia
Subcutaneous Infusions

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

Cite this

@article{e722406f5e954bb2a6c0b259fd0375f8,
title = "Effect of initiating use of an insulin pump in adults with type 1 diabetes using multiple daily insulin injections and continuous glucose monitoring (DIAMOND): a multicentre, randomised controlled trial",
abstract = "Background The benefit of initiation of insulin pump therapy (continuous subcutaneous insulin infusion; CSII) in patients with type 1 diabetes using continuous glucose monitoring (CGM) has not been studied. We aimed to assess glycaemic outcomes when switching from multiple daily injections (MDI) to CSII in adults with type 1 diabetes using CGM. Methods In this multicentre, randomised controlled trial, 75 adults with type 1 diabetes in the CGM group of the DIAMOND trial were randomly assigned via the study website using a computer-generated sequence to continue MDI or switch to CSII, with continuation of CGM, for 28 weeks. The primary outcome was CGM-measured time in the glucose concentration range of 70–180 mg/dL (3·9–10·0 mmol/L). This study is registered with ClinicalTrials.gov, number NCT02282397. Findings Between April 14, 2015, and May 5, 2016, 37 participants were randomly assigned to the CGM plus CSII group and 38 participants were randomly assigned to the CGM plus MDI group. The study was completed by 36 (97{\%}) of 37 participants in the CGM plus CSII group and 35 (92{\%}) of 38 participants in the CGM plus MDI group. Mean CGM use was 6·7 days per week (SD 0·8) in the CGM plus CSII group and 6·9 days per week (0·3) in the CGM plus MDI group (p=0·86). No participants in the CGM plus CSII group who completed the trial discontinued CSII. Over the follow-up period, mean time in the glucose concentration range of 70–180 mg/dL (3·9–10·0 mmol/L) was 791 min per day (SD 157) in the CGM plus CSII group and 741 min per day (225) in the CGM plus MDI group (adjusted mean treatment group difference: 83 min, 95{\%} CI 17–149; p=0·01). Participants in the CGM plus CSII group had a greater reduction in CGM-measured mean glucose (p=0·005) and hyperglycaemia (on four metrics: p=0·007 for >180 mg/dL [>10·0 mmol/L], p=0·02 for >250 mg/dL [>13·9 mmol/L], p=0·04 for >300 mg/dL [>16·6 mmol/L], and p=0·02 for the area under the curve for 180 mg/dL [10·0 mmol/L]), but also an increase in CGM-measured hypoglycaemia (p=0·0001 for <70 mg/dL [<3·9 mmol/L], p=0·0002 for <60 mg/dL [<3·3 mmol/L], p=0·0009 for <50 mg/dL [<2·8 mmol/L], p=0·0002 for the area over the curve for 70 mg/dL [3·9 mmol/L]). Mean HbA1c change from baseline to 28 weeks was 0·3{\%} (SD 0·9; 3·3 mmol/mol [SD 9·8]) in the CGM plus CSII group and 0·1{\%} (0·4; 1·1 mmol/mol [4·4]) in the CGM plus MDI group (p=0·32). Severe hypoglycaemia occurred in one participant in the CGM plus MDI group, and diabetic ketoacidosis and severe hyperglycaemia occurred in one participant each in the CGM plus CSII group. Interpretation Our findings show that glycaemic control measured by time in the glucose range of 70–180 mg/dL (3·9–10·0 mmol/L) is improved by initiation of CSII in adults with type 1 diabetes. However, biochemical hypoglycaemia also was increased in the study, which will be important to consider when incorporating these results into clinical practice. Funding Dexcom.",
author = "{DIAMOND Study Group} and Beck, {Roy W.} and Riddlesworth, {Tonya D.} and Ruedy, {Katrina J.} and Craig Kollman and Andrew Ahmann and Bergenstal, {Richard M.} and Anuj Bhargava and Bode, {Bruce W.} and Stacie Haller and Kruger, {Davida F.} and McGill, {Janet B.} and William Polonsky and David Price and Elena Toschi and Elena Toschi and Howard Wolpert and Astrid Atakov-Castillo and Edvina Markovic and Stephen Aronoff and Satanya Brooks and Gloria Martinez and Angela Mendez and Theresa Dunnam and Anuj Bhargava and Kathy Fitzgerald and Diana Wright and Teck Khoo and Pierre Theuma and Tara Herrold and Debra Thomsen and Richard Bergenstal and Kathleen McCann and Arlene Monk and Char Ashanti and David Liljenquist and Heather Judge and Jean Halford and Davida Kruger and Shiri Levy and Arti Bhan and Terra Cushman and Lameka Dawson and Heather Remtema and Fawn Wolf and James Neifing and Jennifer Murdoch and Susan Staat and Bethany Klopfenstein and Farahnaz Joarder and Jessica Castle",
year = "2017",
month = "9",
day = "1",
doi = "10.1016/S2213-8587(17)30217-6",
language = "English (US)",
volume = "5",
pages = "700--708",
journal = "The Lancet Diabetes and Endocrinology",
issn = "2213-8587",
publisher = "Elsevier BV",
number = "9",

}

TY - JOUR

T1 - Effect of initiating use of an insulin pump in adults with type 1 diabetes using multiple daily insulin injections and continuous glucose monitoring (DIAMOND)

T2 - a multicentre, randomised controlled trial

AU - DIAMOND Study Group

AU - Beck, Roy W.

AU - Riddlesworth, Tonya D.

AU - Ruedy, Katrina J.

AU - Kollman, Craig

AU - Ahmann, Andrew

AU - Bergenstal, Richard M.

AU - Bhargava, Anuj

AU - Bode, Bruce W.

AU - Haller, Stacie

AU - Kruger, Davida F.

AU - McGill, Janet B.

AU - Polonsky, William

AU - Price, David

AU - Toschi, Elena

AU - Toschi, Elena

AU - Wolpert, Howard

AU - Atakov-Castillo, Astrid

AU - Markovic, Edvina

AU - Aronoff, Stephen

AU - Brooks, Satanya

AU - Martinez, Gloria

AU - Mendez, Angela

AU - Dunnam, Theresa

AU - Bhargava, Anuj

AU - Fitzgerald, Kathy

AU - Wright, Diana

AU - Khoo, Teck

AU - Theuma, Pierre

AU - Herrold, Tara

AU - Thomsen, Debra

AU - Bergenstal, Richard

AU - McCann, Kathleen

AU - Monk, Arlene

AU - Ashanti, Char

AU - Liljenquist, David

AU - Judge, Heather

AU - Halford, Jean

AU - Kruger, Davida

AU - Levy, Shiri

AU - Bhan, Arti

AU - Cushman, Terra

AU - Dawson, Lameka

AU - Remtema, Heather

AU - Wolf, Fawn

AU - Neifing, James

AU - Murdoch, Jennifer

AU - Staat, Susan

AU - Klopfenstein, Bethany

AU - Joarder, Farahnaz

AU - Castle, Jessica

PY - 2017/9/1

Y1 - 2017/9/1

N2 - Background The benefit of initiation of insulin pump therapy (continuous subcutaneous insulin infusion; CSII) in patients with type 1 diabetes using continuous glucose monitoring (CGM) has not been studied. We aimed to assess glycaemic outcomes when switching from multiple daily injections (MDI) to CSII in adults with type 1 diabetes using CGM. Methods In this multicentre, randomised controlled trial, 75 adults with type 1 diabetes in the CGM group of the DIAMOND trial were randomly assigned via the study website using a computer-generated sequence to continue MDI or switch to CSII, with continuation of CGM, for 28 weeks. The primary outcome was CGM-measured time in the glucose concentration range of 70–180 mg/dL (3·9–10·0 mmol/L). This study is registered with ClinicalTrials.gov, number NCT02282397. Findings Between April 14, 2015, and May 5, 2016, 37 participants were randomly assigned to the CGM plus CSII group and 38 participants were randomly assigned to the CGM plus MDI group. The study was completed by 36 (97%) of 37 participants in the CGM plus CSII group and 35 (92%) of 38 participants in the CGM plus MDI group. Mean CGM use was 6·7 days per week (SD 0·8) in the CGM plus CSII group and 6·9 days per week (0·3) in the CGM plus MDI group (p=0·86). No participants in the CGM plus CSII group who completed the trial discontinued CSII. Over the follow-up period, mean time in the glucose concentration range of 70–180 mg/dL (3·9–10·0 mmol/L) was 791 min per day (SD 157) in the CGM plus CSII group and 741 min per day (225) in the CGM plus MDI group (adjusted mean treatment group difference: 83 min, 95% CI 17–149; p=0·01). Participants in the CGM plus CSII group had a greater reduction in CGM-measured mean glucose (p=0·005) and hyperglycaemia (on four metrics: p=0·007 for >180 mg/dL [>10·0 mmol/L], p=0·02 for >250 mg/dL [>13·9 mmol/L], p=0·04 for >300 mg/dL [>16·6 mmol/L], and p=0·02 for the area under the curve for 180 mg/dL [10·0 mmol/L]), but also an increase in CGM-measured hypoglycaemia (p=0·0001 for <70 mg/dL [<3·9 mmol/L], p=0·0002 for <60 mg/dL [<3·3 mmol/L], p=0·0009 for <50 mg/dL [<2·8 mmol/L], p=0·0002 for the area over the curve for 70 mg/dL [3·9 mmol/L]). Mean HbA1c change from baseline to 28 weeks was 0·3% (SD 0·9; 3·3 mmol/mol [SD 9·8]) in the CGM plus CSII group and 0·1% (0·4; 1·1 mmol/mol [4·4]) in the CGM plus MDI group (p=0·32). Severe hypoglycaemia occurred in one participant in the CGM plus MDI group, and diabetic ketoacidosis and severe hyperglycaemia occurred in one participant each in the CGM plus CSII group. Interpretation Our findings show that glycaemic control measured by time in the glucose range of 70–180 mg/dL (3·9–10·0 mmol/L) is improved by initiation of CSII in adults with type 1 diabetes. However, biochemical hypoglycaemia also was increased in the study, which will be important to consider when incorporating these results into clinical practice. Funding Dexcom.

AB - Background The benefit of initiation of insulin pump therapy (continuous subcutaneous insulin infusion; CSII) in patients with type 1 diabetes using continuous glucose monitoring (CGM) has not been studied. We aimed to assess glycaemic outcomes when switching from multiple daily injections (MDI) to CSII in adults with type 1 diabetes using CGM. Methods In this multicentre, randomised controlled trial, 75 adults with type 1 diabetes in the CGM group of the DIAMOND trial were randomly assigned via the study website using a computer-generated sequence to continue MDI or switch to CSII, with continuation of CGM, for 28 weeks. The primary outcome was CGM-measured time in the glucose concentration range of 70–180 mg/dL (3·9–10·0 mmol/L). This study is registered with ClinicalTrials.gov, number NCT02282397. Findings Between April 14, 2015, and May 5, 2016, 37 participants were randomly assigned to the CGM plus CSII group and 38 participants were randomly assigned to the CGM plus MDI group. The study was completed by 36 (97%) of 37 participants in the CGM plus CSII group and 35 (92%) of 38 participants in the CGM plus MDI group. Mean CGM use was 6·7 days per week (SD 0·8) in the CGM plus CSII group and 6·9 days per week (0·3) in the CGM plus MDI group (p=0·86). No participants in the CGM plus CSII group who completed the trial discontinued CSII. Over the follow-up period, mean time in the glucose concentration range of 70–180 mg/dL (3·9–10·0 mmol/L) was 791 min per day (SD 157) in the CGM plus CSII group and 741 min per day (225) in the CGM plus MDI group (adjusted mean treatment group difference: 83 min, 95% CI 17–149; p=0·01). Participants in the CGM plus CSII group had a greater reduction in CGM-measured mean glucose (p=0·005) and hyperglycaemia (on four metrics: p=0·007 for >180 mg/dL [>10·0 mmol/L], p=0·02 for >250 mg/dL [>13·9 mmol/L], p=0·04 for >300 mg/dL [>16·6 mmol/L], and p=0·02 for the area under the curve for 180 mg/dL [10·0 mmol/L]), but also an increase in CGM-measured hypoglycaemia (p=0·0001 for <70 mg/dL [<3·9 mmol/L], p=0·0002 for <60 mg/dL [<3·3 mmol/L], p=0·0009 for <50 mg/dL [<2·8 mmol/L], p=0·0002 for the area over the curve for 70 mg/dL [3·9 mmol/L]). Mean HbA1c change from baseline to 28 weeks was 0·3% (SD 0·9; 3·3 mmol/mol [SD 9·8]) in the CGM plus CSII group and 0·1% (0·4; 1·1 mmol/mol [4·4]) in the CGM plus MDI group (p=0·32). Severe hypoglycaemia occurred in one participant in the CGM plus MDI group, and diabetic ketoacidosis and severe hyperglycaemia occurred in one participant each in the CGM plus CSII group. Interpretation Our findings show that glycaemic control measured by time in the glucose range of 70–180 mg/dL (3·9–10·0 mmol/L) is improved by initiation of CSII in adults with type 1 diabetes. However, biochemical hypoglycaemia also was increased in the study, which will be important to consider when incorporating these results into clinical practice. Funding Dexcom.

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U2 - 10.1016/S2213-8587(17)30217-6

DO - 10.1016/S2213-8587(17)30217-6

M3 - Article

VL - 5

SP - 700

EP - 708

JO - The Lancet Diabetes and Endocrinology

JF - The Lancet Diabetes and Endocrinology

SN - 2213-8587

IS - 9

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