Continuous Glucose Monitoring with Structured Education in Adults with Type 2 Diabetes Managed by Multiple Daily Insulin Injections: a Multicentre Randomised Controlled Trial

Overview

Journal Diabetologia

Specialty Endocrinology

Date 2024 Apr 19

PMID 38639876

Authors

Ji Yoon Kim

Sang-Man Jin

Kang Hee Sim

Bo-Yeon Kim

Jae Hyoung Cho

Jun Sung Moon

Soo Lim

Eun Seok Kang

Cheol-Young Park

Sin Gon Kim

Jae Hyeon Kim

Affiliations

Soon will be listed here.

Abstract

Aims/hypothesis: The aim of this study was to compare the effectiveness of stand-alone intermittently scanned continuous glucose monitoring (isCGM) with or without a structured education programme and blood glucose monitoring (BGM) in adults with type 2 diabetes on multiple daily insulin injections (MDI).

Methods: In this 24 week randomised open-label multicentre trial, adults with type 2 diabetes on intensive insulin therapy with HbA levels of 58-108 mmol/mol (7.5-12.0%) were randomly assigned in a 1:1:1 ratio to isCGM with a structured education programme on adjusting insulin dose and timing according to graphical patterns in CGM (intervention group), isCGM with conventional education (control group 1) or BGM with conventional education (control group 2). Block randomisation was conducted by an independent statistician. Due to the nature of the intervention, blinding of participants and investigators was not possible. The primary outcome was change in HbA from baseline at 24 weeks, assessed using ANCOVA with the baseline value as a covariate.

Results: A total of 159 individuals were randomised (n=53 for each group); 148 were included in the full analysis set, with 52 in the intervention group, 49 in control group 1 and 47 in control group 2. The mean (± SD) HbA level at baseline was 68.19±10.94 mmol/mol (8.39±1.00%). The least squares mean change (± SEM) from baseline HbA at 24 weeks was -10.96±1.35 mmol/mol (-1.00±0.12%) in the intervention group, -6.87±1.39 mmol/mol (-0.63±0.13%) in control group 1 (p=0.0367 vs intervention group) and -6.32±1.42 mmol/mol (-0.58±0.13%) in control group 2 (p=0.0193 vs intervention group). Adverse events occurred in 28.85% (15/52) of individuals in the intervention group, 26.42% (14/53) in control group 1 and 48.08% (25/52) in control group 2.

Conclusions/interpretation: Stand-alone isCGM offers a greater reduction in HbA in adults with type 2 diabetes on MDI when education on the interpretation of graphical patterns in CGM is provided.

Trial Registration: ClinicalTrials.gov NCT04926623.

Funding: This study was supported by Daewoong Pharmaceutical Co., Ltd.

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References

ElSayed N, Aleppo G, Aroda V, Bannuru R, Brown F, Bruemmer D . 6. Glycemic Targets: Standards of Care in Diabetes-2023. Diabetes Care. 2022; 46(Suppl 1):S97-S110. PMC: 9810469. DOI: 10.2337/dc23-S006. View

Yoo J, Kim J . Time in Range from Continuous Glucose Monitoring: A Novel Metric for Glycemic Control. Diabetes Metab J. 2021; 44(6):828-839. PMC: 7801761. DOI: 10.4093/dmj.2020.0257. View

Yoo J, Kim J . Advances in Continuous Glucose Monitoring and Integrated Devices for Management of Diabetes with Insulin-Based Therapy: Improvement in Glycemic Control. Diabetes Metab J. 2023; 47(1):27-41. PMC: 9925143. DOI: 10.4093/dmj.2022.0271. View

Aleppo G, Ruedy K, Riddlesworth T, Kruger D, Peters A, Hirsch I . REPLACE-BG: A Randomized Trial Comparing Continuous Glucose Monitoring With and Without Routine Blood Glucose Monitoring in Adults With Well-Controlled Type 1 Diabetes. Diabetes Care. 2017; 40(4):538-545. PMC: 5864100. DOI: 10.2337/dc16-2482. View

Haak T, Hanaire H, Ajjan R, Hermanns N, Riveline J, Rayman G . Flash Glucose-Sensing Technology as a Replacement for Blood Glucose Monitoring for the Management of Insulin-Treated Type 2 Diabetes: a Multicenter, Open-Label Randomized Controlled Trial. Diabetes Ther. 2016; 8(1):55-73. PMC: 5306122. DOI: 10.1007/s13300-016-0223-6. View

Cappon G, Vettoretti M, Sparacino G, Facchinetti A . Continuous Glucose Monitoring Sensors for Diabetes Management: A Review of Technologies and Applications. Diabetes Metab J. 2019; 43(4):383-397. PMC: 6712232. DOI: 10.4093/dmj.2019.0121. View

Beck R, Riddlesworth T, Ruedy K, Ahmann A, Bergenstal R, Haller S . Effect of Continuous Glucose Monitoring on Glycemic Control in Adults With Type 1 Diabetes Using Insulin Injections: The DIAMOND Randomized Clinical Trial. JAMA. 2017; 317(4):371-378. DOI: 10.1001/jama.2016.19975. View

Lind M, Polonsky W, Hirsch I, Heise T, Bolinder J, Dahlqvist S . Continuous Glucose Monitoring vs Conventional Therapy for Glycemic Control in Adults With Type 1 Diabetes Treated With Multiple Daily Insulin Injections: The GOLD Randomized Clinical Trial. JAMA. 2017; 317(4):379-387. DOI: 10.1001/jama.2016.19976. View

Tumminia A, Crimi S, Sciacca L, Buscema M, Frittitta L, Squatrito S . Efficacy of real-time continuous glucose monitoring on glycaemic control and glucose variability in type 1 diabetic patients treated with either insulin pumps or multiple insulin injection therapy: a randomized controlled crossover trial. Diabetes Metab Res Rev. 2014; 31(1):61-8. DOI: 10.1002/dmrr.2557. View

10.

Battelino T, Conget I, Olsen B, Schutz-Fuhrmann I, Hommel E, Hoogma R . The use and efficacy of continuous glucose monitoring in type 1 diabetes treated with insulin pump therapy: a randomised controlled trial. Diabetologia. 2012; 55(12):3155-62. PMC: 3483098. DOI: 10.1007/s00125-012-2708-9. View

11.

Deiss D, Bolinder J, Riveline J, Battelino T, Bosi E, Tubiana-Rufi N . Improved glycemic control in poorly controlled patients with type 1 diabetes using real-time continuous glucose monitoring. Diabetes Care. 2006; 29(12):2730-2. DOI: 10.2337/dc06-1134. View

12.

OConnell M, Donath S, ONeal D, Colman P, Ambler G, Jones T . Glycaemic impact of patient-led use of sensor-guided pump therapy in type 1 diabetes: a randomised controlled trial. Diabetologia. 2009; 52(7):1250-7. DOI: 10.1007/s00125-009-1365-0. View

13.

Bolinder J, Antuna R, Geelhoed-Duijvestijn P, Kroger J, Weitgasser R . Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial. Lancet. 2016; 388(10057):2254-2263. DOI: 10.1016/S0140-6736(16)31535-5. View

14.

Hermanns N, Schumann B, Kulzer B, Haak T . The impact of continuous glucose monitoring on low interstitial glucose values and low blood glucose values assessed by point-of-care blood glucose meters: results of a crossover trial. J Diabetes Sci Technol. 2014; 8(3):516-22. PMC: 4455434. DOI: 10.1177/1932296814524105. View

15.

Van Beers C, DeVries J, Kleijer S, Smits M, Geelhoed-Duijvestijn P, Kramer M . Continuous glucose monitoring for patients with type 1 diabetes and impaired awareness of hypoglycaemia (IN CONTROL): a randomised, open-label, crossover trial. Lancet Diabetes Endocrinol. 2016; 4(11):893-902. DOI: 10.1016/S2213-8587(16)30193-0. View

16.

Heinemann L, Freckmann G, Ehrmann D, Faber-Heinemann G, Guerra S, Waldenmaier D . Real-time continuous glucose monitoring in adults with type 1 diabetes and impaired hypoglycaemia awareness or severe hypoglycaemia treated with multiple daily insulin injections (HypoDE): a multicentre, randomised controlled trial. Lancet. 2018; 391(10128):1367-1377. DOI: 10.1016/S0140-6736(18)30297-6. View

17.

Battelino T, Phillip M, Bratina N, Nimri R, Oskarsson P, Bolinder J . Effect of continuous glucose monitoring on hypoglycemia in type 1 diabetes. Diabetes Care. 2011; 34(4):795-800. PMC: 3064030. DOI: 10.2337/dc10-1989. View

18.

Seyed Ahmadi S, Westman K, Pivodic A, Olafsdottir A, Dahlqvist S, Hirsch I . The Association Between HbA and Time in Hypoglycemia During CGM and Self-Monitoring of Blood Glucose in People With Type 1 Diabetes and Multiple Daily Insulin Injections: A Randomized Clinical Trial (GOLD-4). Diabetes Care. 2020; 43(9):2017-2024. PMC: 7440892. DOI: 10.2337/dc19-2606. View

19.

Sequeira P, Montoya L, Ruelas V, Xing D, Chen V, Beck R . Continuous glucose monitoring pilot in low-income type 1 diabetes patients. Diabetes Technol Ther. 2013; 15(10):855-8. PMC: 3781124. DOI: 10.1089/dia.2013.0072. View

20.

Beck R, Riddlesworth T, Ruedy K, Ahmann A, Haller S, Kruger D . Continuous Glucose Monitoring Versus Usual Care in Patients With Type 2 Diabetes Receiving Multiple Daily Insulin Injections: A Randomized Trial. Ann Intern Med. 2017; 167(6):365-374. DOI: 10.7326/M16-2855. View