Effect of divergent continuous glucose monitoring technologies on glycaemic control in type 1 diabetes mellitus: A systematic review and meta-analysis of randomised controlled trials

Mona Elbalshy, Jillian Haszard, Hazel Smith, Sarahmarie Kuroko, Barbara Galland, Nick Oliver, Viral Shah, Martin I de Bock, Benjamin J Wheeler, Mona Elbalshy, Jillian Haszard, Hazel Smith, Sarahmarie Kuroko, Barbara Galland, Nick Oliver, Viral Shah, Martin I de Bock, Benjamin J Wheeler

Abstract

Aims: We aimed to conduct a systematic review and meta-analysis of randomised controlled clinical trials (RCTs) assessing separately and together the effect of the three distinct categories of continuous glucose monitoring (CGM) systems (adjunctive, non-adjunctive and intermittently-scanned CGM [isCGM]), compared with traditional capillary glucose monitoring, on HbA1c and CGM metrics.

Methods: PubMed, Web of Science, Scopus and Cochrane Central register of clinical trials were searched. Inclusion criteria were as follows: randomised controlled trials; participants with type 1 diabetes of any age and insulin regimen; investigating CGM and isCGM compared with traditional capillary glucose monitoring; and reporting glycaemic outcomes of HbA1c and/or time-in-range (TIR). Glycaemic outcomes were extracted post-intervention and expressed as mean differences and 95%CIs between treatment and comparator groups. Results were pooled using a random-effects meta-analysis. Risk of bias was assessed using the Cochrane Rob2 tool.

Results: This systematic review was conducted between January and April 2021; it included 22 RCTs (15 adjunctive, 5 non-adjunctive, and 2 isCGM)). The overall analysis of the pooled three categories showed a statistically significant absolute improvement in HbA1c percentage points (mean difference (95% CI): -0.22% [-0.31 to -0.14], I2 = 79%) for intervention compared with comparator and was strongest for adjunctive CGM (-0.26% [-0.36, -0.16]). Overall TIR (absolute change) increased by 5.4% (3.5 to 7.2), I2 = 71% for CGM intervention compared with comparator and was strongest with non-adjunctive CGM (6.0% [2.3, 9.7]).

Conclusions: For individuals with T1D, use of CGM was beneficial for impacting glycaemic outcomes including HbA1c, TIR and time-below-range (TBR). Glycaemic improvement appeared greater for TIR for newer non-adjunctive CGM technology.

Keywords: CGM metrics; HbA1c; adjunctive CGM; continuous glucose monitoring; isCGM; non-adjunctive CGM; type 1 diabetes.

Conflict of interest statement

BJW has previously received research funding from Dexcom, Medtronic and iSENS. NO has received research funding from Dexcom, Roche Diabetes and Medtronic Diabetes and has participated in advisory boards for Dexcom, Roche Diabetes and Medtronic Diabetes. MIdB received Research funding from: Novo Nordisk, Medtronic, Dexcom, Pfizer and Research support from Medtronic, Dexcom, SOOIL, Honoraria from Medtronic. VNS reported receiving research supports through University of Colorado from Sanofi, Novo Nordisk, Eli‐Lilly, Insulet, Dexcom, Abbott, vTv Therapeutics, JDRF and NIH. VNS’ employer also received honoraria from Dexcom, insulet, Medscape and Sanofi for speaking, consulting or being on advisory board. ME, HS, JH, BG and SK declare no conflict of interest.

© 2022 The Authors. Diabetic Medicine published by John Wiley & Sons Ltd on behalf of Diabetes UK.

Figures

FIGURE 1
FIGURE 1
Flowchart of the recruitment process. CGM – continuous glucose monitoring; RCT – randomised controlled trail
FIGURE 2
FIGURE 2
Forest plot of meta‐analysis of continuous glucose monitoring randomised controlled trials for HbA1c by non‐adjunctive, adjunctive and intermittent scanning technologies
FIGURE 3
FIGURE 3
Forest plot of meta‐analysis of randomised controlled trails for time‐in‐range by non‐adjunctive, adjunctive and intermittent scanning technologies
FIGURE 4
FIGURE 4
Forest plot of meta‐analysis of randomised controlled trails for time‐below‐range (

References

    1. DiMeglio LA, Evans‐Molina C, Oram RA. Type 1 diabetes. Lancet. 2018;391(10138):2449‐2462.
    1. Bloomgarden ZT. Type 1 diabetes and glucose monitoring. Diabet Care. 2007;30(11):2965‐2971.
    1. Patton SR, Clements MA. Continuous glucose monitoring versus self‐monitoring of blood glucose in children with type 1 diabetes‐are there pros and cons for both? US Endocrinol Summer. 2012;8(1):27‐29.
    1. Heinemann L. Finger pricking and pain: a never ending story. J Diabet Sci Technol. 2008;2(5):919‐921. 10.1177/193229680800200526
    1. Blackwell M, Wheeler BJ. Clinical review: the misreporting of logbook, download, and verbal self‐measured blood glucose in adults and children with type I diabetes. Acta Diabetol. 2017;54(1):1‐8. 10.1007/s00592-016-0907-4
    1. Pfeiffer E‐F. The, “Ulm Zucker Uhr System” and its consequences. Horm Metab Res. 1994;26(11):510‐514.
    1. Rodbard D. Continuous glucose monitoring: a review of successes, challenges, and opportunities. Diabet Technol Ther. 2016;18(S2):S2‐3‐S2‐13.
    1. Funtanilla VD, Caliendo T, Hilas O. Continuous glucose monitoring: a review of available systems. P and T. 2019;44(9):550.
    1. Cappon G, Vettoretti M, Sparacino G, Facchinetti A. Continuous glucose monitoring sensors for diabetes management: a review of technologies and applications. Diabet Metab J. 2019;43(4):383‐397.
    1. Blauw H, Onvlee AJ, Klaassen M, van Bon AC, DeVries JH. Fully closed loop glucose control with a bihormonal artificial pancreas in adults with type 1 diabetes: an outpatient, randomized, crossover trial. Diabet Care. 2021;44(3):836‐838.
    1. Maiorino MI, Signoriello S, Maio A, et al. Effects of continuous glucose monitoring on metrics of glycemic control in diabetes: a systematic review with meta‐analysis of randomized controlled trials. Diabet Care. 2020;43(5):1146‐1156.
    1. Castellana M, Parisi C, Di Molfetta S, et al. Efficacy and safety of flash glucose monitoring in patients with type 1 and type 2 diabetes: a systematic review and meta‐analysis. BMJ Open Diabet Res Care. 2020;8(1):e001092.
    1. Beck RW, Brown SA, Lum JW, Kovatchev BP. Nonadjunctive use of continuous glucose monitoring: the end of fingersticks? Diabet Technol Ther. 2020;22(2):67‐68.
    1. FDA Advisory Panel . FDA advisory panel votes to recommend non‐adjunctive use of Dexcom G5 mobile CGM. Diabetes Technol Ther. 2016;18:512‐516.
    1. Accessed 31/12/2021, 2021.
    1. Rodbard D. Glucose time in range, time above range, and time below range depend on mean or median glucose or HbA1c, glucose coefficient of variation, and shape of the glucose distribution. Diabet Technol Ther. 2020;22(7):492‐500.
    1. Gabbay MAL, Rodacki M, Calliari LE, et al. Time in range: a new parameter to evaluate blood glucose control in patients with diabetes. Diabetol Metab Syndr. 2020;12(1):1‐8.
    1. Battelino T, Danne T, Bergenstal RM, et al. Clinical targets for continuous glucose monitoring data interpretation: recommendations from the international consensus on time in range. Diabet Care. 2019;42(8):1593‐1603. 10.2337/dci19-0028
    1. Dicembrini I, Cosentino C, Monami M, Mannucci E, Pala L. Effects of real‐time continuous glucose monitoring in type 1 diabetes: a meta‐analysis of randomized controlled trials. Acta Diabetol. 2021;58(4):401‐410.
    1. Benkhadra K, Alahdab F, Tamhane S, et al. Real‐time continuous glucose monitoring in type 1 diabetes: a systematic review and individual patient data meta‐analysis. Clin Endocrinol. 2017;86(3):354‐360.
    1. Ouzzani M, Hammady H, Fedorowicz Z, Elmagarmid A. Rayyan—a web and mobile app for systematic reviews. Syst Rev. 2016;5(1):210.
    1. Sterne JAC, Savovic J, Page MJ, et al. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ. 2019;366:l4898‐10.1136/bmj.l4898
    1. McGrath S, Sohn H, Steele R, Benedetti A. Meta‐analysis of the difference of medians. Biom J. 2020;62(1):69‐98.
    1. Altman DG, Bland JM. How to obtain the confidence interval from a P value. BMJ. 2011;343:d2090.
    1. Collaboration C . Obtaining standard deviations from standard errors and confidence intervals for group means. In: Higgins JPT, Green S, eds. Cochrane Handbook for systematic reviews of interventions. 2011;5. Version 5.1.0.
    1. Hirsch IB, Abelseth J, Bode BW, et al. Sensor‐augmented insulin pump therapy: results of the first randomized treat‐to‐target study. Diabet Technol Ther. 2008;10(5):377‐383.
    1. Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group . Continuous glucose monitoring and intensive treatment of type 1 diabetes. N Engl J Med. 2008;359(14):1464‐1476.
    1. Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group . The effect of continuous glucose monitoring in well‐controlled type 1 diabetes. Diabet Care. 2009;32(8):1378‐1383.
    1. Mauras N, Beck R, Xing D, et al. A randomized clinical trial to assess the efficacy and safety of real‐time continuous glucose monitoring in the management of type 1 diabetes in young children aged 4 to<10 years. Diabet Care. 2012;35(2):204‐210.
    1. Battelino T, Phillip M, Bratina N, Nimri R, Oskarsson P, Bolinder J. Effect of continuous glucose monitoring on hypoglycemia in type 1 diabetes. Diabet Care. 2011;34(4):795‐800.
    1. Battelino T, Conget I, Olsen B, et al. 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):3155‐3162.
    1. Deiss D, Bolinder J, Riveline J‐P, et al. Improved glycemic control in poorly controlled patients with type 1 diabetes using real‐time continuous glucose monitoring. Diabet Care. 2006;29(12):2730‐2732.
    1. Feig DS, Donovan LE, Corcoy R, et al. Continuous glucose monitoring in pregnant women with type 1 diabetes (CONCEPTT): a multicentre international randomised controlled trial. Lancet. 2017;390(10110):2347‐2359.
    1. Lind M, Polonsky W, Hirsch IB, et al. 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.
    1. Beck RW, Riddlesworth T, Ruedy K, et al. 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.
    1. O’Connell MA, Donath S, O’Neal DN, et al. Glycaemic impact of patient‐led use of sensor‐guided pump therapy in type 1 diabetes: a randomised controlled trial. Diabetologia. 2009;52(7):1250‐1257.
    1. Raccah D, Sulmont V, Reznik Y, et al. Incremental value of continuous glucose monitoring when starting pump therapy in patients with poorly controlled type 1 diabetes: the RealTrend study. Diabet Care. 2009;32(12):2245‐2250.
    1. Kordonouri O, Pankowska E, Rami B, et al. Sensor‐augmented pump therapy from the diagnosis of childhood type 1 diabetes: results of the Paediatric Onset Study (ONSET) after 12 months of treatment. Diabetologia. 2010;53(12):2487‐2495.
    1. van Beers CAJ, DeVries JH, Kleijer SJ, et al. Continuous glucose monitoring for patients with type 1 diabetes and impaired awareness of hypoglycaemia (IN CONTROL): a randomised, open‐label, crossover trial. Lancet Diabet Endocrinol. 2016;4(11):893‐902.
    1. Little SA, Leelarathna L, Walkinshaw E, et al. Recovery of hypoglycemia awareness in long‐standing type 1 diabetes: a multicenter 2× 2 factorial randomized controlled trial comparing insulin pump with multiple daily injections and continuous with conventional glucose self‐monitoring (HypoCOMPaSS). Diabet Care. 2014;37(8):2114‐2122.
    1. Laffel LM, Kanapka LG, Beck RW, et al. Effect of continuous glucose monitoring on glycemic control in adolescents and young adults with type 1 diabetes: a randomized clinical trial. JAMA. 2020;323(23):2388‐2396.
    1. Pratley RE, Kanapka LG, Rickels MR, et al. Effect of continuous glucose monitoring on hypoglycemia in older adults with type 1 diabetes: a randomized clinical trial. JAMA. 2020;323(23):2397‐2406.
    1. Heinemann L, Freckmann G, Ehrmann D, et al. 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.
    1. Group StENCUiECS, Group: StENCUiECS . A randomized clinical trial assessing continuous glucose monitoring (CGM) use with standardized education with or without a family behavioral intervention compared with fingerstick blood glucose monitoring in very young children with type 1 diabetes. Diabet Care. 2021;44(2):464‐472.
    1. Thabit H, Prabhu JN, Mubita W, et al. Use of factory‐calibrated real‐time continuous glucose monitoring improves time in target and HbA1c in a multiethnic cohort of adolescents and young adults with type 1 diabetes: the MILLENNIALS study. Diabet Care. 2020;43(10):2537‐2543.
    1. Boucher SE, Gray AR, Wiltshire EJ, et al. Effect of 6 months of flash glucose monitoring in youth with type 1 diabetes and high‐risk glycemic control: a randomized controlled trial. Diabet Care. 2020;43(10):2388‐2395.
    1. Bolinder J, Antuna R, Geelhoed‐Duijvestijn P, Kröger 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.
    1. Sequeira PA, Montoya L, Ruelas V, et al. Continuous glucose monitoring pilot in low‐income type 1 diabetes patients. Diabet Technol Ther. 2013;15(10):855‐858.
    1. Oskarsson P, Antuna R, Geelhoed‐Duijvestijn P, Krӧger J, Weitgasser R, Bolinder J. Impact of flash glucose monitoring on hypoglycaemia in adults with type 1 diabetes managed with multiple daily injection therapy: a pre‐specified subgroup analysis of the IMPACT randomised controlled trial. Diabetologia. 2018;61(3):539‐550.
    1. Wright LA‐C, Hirsch IB. Metrics beyond hemoglobin A1C in diabetes management: time in range, hypoglycemia, and other parameters. Diabet Technol Ther. 2017;19(S2):S‐16‐S‐26.
    1. Sandercock P. The authors say: ‘The data are not so robust because of heterogeneity’ ‐ so, how should I deal with this systematic review? Meta‐analysis and the Clinician. Cerebrovasc Dis. 2011;31(6):615‐620. 10.1159/000326068
    1. Prahalad P, Ebekozien O, Alonso GT, et al. Multi‐clinic quality improvement initiative increases continuous glucose monitoring use among adolescents and young adults with type 1 diabetes. Clin Diabet. 2021;39(3):264‐271. 10.2337/cd21-0026
    1. Weisman A, Bai JW, Cardinez M, Kramer CK, Perkins BA. Effect of artificial pancreas systems on glycaemic control in patients with type 1 diabetes: a systematic review and meta‐analysis of outpatient randomised controlled trials. Lancet Diabet Endocrinol. 2017;5(7):501‐512. 10.1016/S2213-8587(17)30167-5
    1. Bekiari E, Kitsios K, Thabit H, et al. Artificial pancreas treatment for outpatients with type 1 diabetes: systematic review and meta‐analysis. BMJ. 2018;361:k1310. 10.1136/bmj.k1310
    1. Visser MM, Charleer S, Fieuws S, et al. Comparing real‐time and intermittently scanned continuous glucose monitoring in adults with type 1 diabetes (ALERTT1): a 6‐month, prospective, multicentre, randomised controlled trial. Lancet. 2021;397(10291):2275‐2283. 10.1016/S0140-6736(21)00789-3
    1. Dunn TC, Xu Y, Hayter G, Ajjan RA. Real‐world flash glucose monitoring patterns and associations between self‐monitoring frequency and glycaemic measures: a European analysis of over 60 million glucose tests. Diabet Res Clin Pract. 2018;137:37‐46. 10.1016/j.diabres.2017.12.015
    1. Karter AJ, Parker MM, Moffet HH, Gilliam LK, Dlott R. Association of real‐time continuous glucose monitoring with glycemic control and acute metabolic events among patients with insulin‐treated diabetes. JAMA. 2021;325(22):2273‐2284. 10.1001/jama.2021.6530
    1. van der Linden J, Welsh JB, Walker TC. Sustainable use of a real‐time continuous glucose monitoring system from 2018 to 2020. Diabet Technol Ther. 2021;23(7):508‐511. 10.1089/dia.2021.0014

Source: PubMed

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

3
Abonnere