Effects of real-time continuous glucose monitoring in type 1 diabetes: a meta-analysis of randomized controlled trials.
Adult
Blood Glucose
/ analysis
Blood Glucose Self-Monitoring
/ instrumentation
Computer Systems
Diabetes Mellitus, Type 1
/ blood
Female
Glycated Hemoglobin
/ analysis
Glycemic Control
/ instrumentation
Humans
Hypoglycemia
/ drug therapy
Hypoglycemic Agents
/ therapeutic use
Insulin
/ administration & dosage
Insulin Infusion Systems
Male
Quality of Life
Randomized Controlled Trials as Topic
/ statistics & numerical data
Continuous glucose monitoring
Flash glucose monitoring
Type 1 diabetes
Journal
Acta diabetologica
ISSN: 1432-5233
Titre abrégé: Acta Diabetol
Pays: Germany
ID NLM: 9200299
Informations de publication
Date de publication:
Apr 2021
Apr 2021
Historique:
received:
05
06
2020
accepted:
30
07
2020
pubmed:
14
8
2020
medline:
5
6
2021
entrez:
14
8
2020
Statut:
ppublish
Résumé
Self-monitoring of blood glucose (SMBG) represented a major breakthrough in the treatment of type 1 diabetes. The aim of the present meta-analysis is to assess the effect of continues glucose monitoring (CGM) and flash glucose monitoring (FGM), on glycemic control in type 1 diabetes. The present analysis includes randomized clinical trials comparing CGM or FGM with SMBG, with a duration of at least 12 weeks, identified in Medline or clinicaltrials.gov. The principal endpoint was HbA1c at the end of the trial. A secondary endpoint was severe hypoglycemia. Mean and 95% confidence intervals for HbA1c and Mantel-Haenzel odds ratio [MH-OR] for severe hypoglycemia were calculated, using random effect models. A sensitivity analysis was performed using fixed effect models. In addition, the following secondary endpoints were explored, using the same methods: time in range, health-related quality of life, and treatment satisfaction. Separate analyses were performed for trials comparing CGM with SMBG, and those comparing CGM + CSII and SMBG + MDI and CGM-regulated insulin infusion system (CRIS) and CSII + SMBG. CGM was associated with a significantly lower HbA1c at endpoint in comparison with SMBG (- 0.24 [- 0.34, - 0.13]%); CGM was associated with a significantly lower risk of severe hypoglycemia than SMBG. Treatment satisfaction and quality of life were not measured, or not reported, in the majority of studies. FGM showed a significant reduction in the incidence of mild hypoglycemia and an increased treatment satisfaction, but no significant results are shown in HbA1c. CGM + CSII in comparison with SMBG + MDI was associated with a significant reduction in HbA1c. Only two trials with a duration of at least 12 weeks compared a CRIS with SMBG + CSII; HbA1c between the two treatment arms was not statistically significant (difference in means: - 0.23 [- 0.91; 0.46]%; p = 0.52). GCM compared to SMBG has showed a reduction in HbA1c and severe hypoglycemia in patient with type 1 diabetes. The comparison between CGM + CSII and SMBG + MDI showed a large reduction in HbA1c; it is conceivable that the effects of CSII + CGM on glycemic control additives. The only comparison available between FGM and SMBG was conducted in patients in good control.
Identifiants
pubmed: 32789691
doi: 10.1007/s00592-020-01589-3
pii: 10.1007/s00592-020-01589-3
doi:
Substances chimiques
Blood Glucose
0
Glycated Hemoglobin A
0
Hypoglycemic Agents
0
Insulin
0
Types de publication
Journal Article
Meta-Analysis
Langues
eng
Sous-ensembles de citation
IM
Pagination
401-410Références
Nathan DM, Genuth S, Lachin J et al (1993) The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 329(14):977–986. https://doi.org/10.1056/nejm199309303291401
doi: 10.1056/nejm199309303291401
pubmed: 8366922
Zimmerman BR (1994) Glycaemia control in diabetes mellitus. Towards the normal profile? Drugs 47(4):611–621. https://doi.org/10.2165/00003495-199447040-00005
doi: 10.2165/00003495-199447040-00005
pubmed: 7516860
Benkhadra K, Alahdab F, Tamhane S et al (2017) Real-time continuous glucose monitoring in type 1 diabetes: a systematic review and individual patient data meta-analysis. Clin Endocrinol (Oxf) 86(3):354–360. https://doi.org/10.1111/cen.13290
doi: 10.1111/cen.13290
Floyd B, Chandra P, Hall S et al (2012) Comparative analysis of the efficacy of continuous glucose monitoring and self-monitoring of blood glucose in type 1 diabetes mellitus. J Diabetes Sci Technol 6(5):1094–1102. https://doi.org/10.1177/193229681200600513
doi: 10.1177/193229681200600513
pubmed: 23063035
pmcid: 3570843
Langendam M, Luijf YM, Hooft L, Devries JH, Mudde AH, Scholten RJ (2012) Continuous glucose monitoring systems for type 1 diabetes mellitus. Cochrane Database Syst Rev 1:Cd008101. https://doi.org/10.1002/14651858.cd008101.pub2
doi: 10.1002/14651858.cd008101.pub2
pubmed: 22258980
Leelarathna L, Wilmot EG (2018) Flash forward: a review of flash glucose monitoring. Diabet Med 35(4):472–482. https://doi.org/10.1111/dme.13584
doi: 10.1111/dme.13584
pubmed: 29356072
Weinzimer SA, Tamborlane WV (2008) Sensor-augmented pump therapy in type 1 diabetes. Curr Opin Endocrinol Diabetes Obes 15(2):118–122. https://doi.org/10.1097/MED.0b013e3282f7960b
doi: 10.1097/MED.0b013e3282f7960b
pubmed: 18316945
Weisman A, Bai JW, Cardinez M, Kramer CK, Perkins BA (2017) 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 Diabetes Endocrinol 5(7):501–512. https://doi.org/10.1016/s2213-8587(17)30167-5
doi: 10.1016/s2213-8587(17)30167-5
pubmed: 28533136
Battelino T, Danne T, Bergenstal RM et al (2019) Clinical targets for continuous glucose monitoring data interpretation: recommendations from the international consensus on time in range. Diabetes Care 42(8):1593–1603. https://doi.org/10.2337/dci19-0028
doi: 10.2337/dci19-0028
pubmed: 31177185
pmcid: 6973648
Soupal J, Parkin CG (2020) Response to Comment on Soupal et al. Glycemic outcomes in adults with T1D are impacted more by continuous glucose monitoring than by insulin delivery method: 3 years of follow-up from the COMISAIR study. Diabetes Care 43:37–43. https://doi.org/10.2337/dci20-0005 (Diabetes Care 43(4): e54–e55)
doi: 10.2337/dci20-0005
pubmed: 31530663
Dicembrini I, Pala L, Caliri M et al (2020) Combined continuous glucose monitoring and subcutaneous insulin infusion versus self-monitoring of blood glucose with optimized multiple injections in people with type 1 diabetes: a randomized crossover trial. Diabetes Obes Metab. https://doi.org/10.1111/dom.14028
doi: 10.1111/dom.14028
pubmed: 32166907
Liberati A, Altman DG, Tetzlaff J et al (2009) The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration. BMJ 339:b2700. https://doi.org/10.1136/bmj.b2700
doi: 10.1136/bmj.b2700
pubmed: 2714672
pmcid: 2714672
Guyatt GH, Oxman AD, Vist GE et al (2008) GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ 336(7650):924–926. https://doi.org/10.1136/bmj.39489.470347.AD
doi: 10.1136/bmj.39489.470347.AD
pubmed: 18436948
pmcid: 2335261
Battelino T, Phillip M, Bratina N, Nimri R, Oskarsson P, Bolinder J (2011) Effect of continuous glucose monitoring on hypoglycemia in type 1 diabetes. Diabetes Care 34(4):795–800. https://doi.org/10.2337/dc10-1989
doi: 10.2337/dc10-1989
pubmed: 21335621
pmcid: 3064030
Battelino T, Conget I, Olsen B et al (2012) The use and efficacy of continuous glucose monitoring in type 1 diabetes treated with insulin pump therapy: a randomised controlled trial. Diabetologia 55(12):3155–3162. https://doi.org/10.1007/s00125-012-2708-9
doi: 10.1007/s00125-012-2708-9
pubmed: 22965294
pmcid: 3483098
Beck RW, Riddlesworth TD, Ruedy KJ et al (2017) 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. Lancet Diabetes Endocrinol 5(9):700–708. https://doi.org/10.1016/s2213-8587(17)30217-6
doi: 10.1016/s2213-8587(17)30217-6
pubmed: 28711468
Deiss D, Bolinder J, Riveline JP et al (2006) Improved glycemic control in poorly controlled patients with type 1 diabetes using real-time continuous glucose monitoring. Diabetes Care 29(12):2730–2732. https://doi.org/10.2337/dc06-1134
doi: 10.2337/dc06-1134
pubmed: 17130215
Heinemann L, Freckmann G, Ehrmann D et al (2018) 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 391(10128):1367–1377. https://doi.org/10.1016/s0140-6736(18)30297-6
doi: 10.1016/s0140-6736(18)30297-6
pubmed: 29459019
Hirsch IB, Abelseth J, Bode BW et al (2008) Sensor-augmented insulin pump therapy: results of the first randomized treat-to-target study. Diabetes Technol Ther 10(5):377–383. https://doi.org/10.1089/dia.2008.0068
doi: 10.1089/dia.2008.0068
pubmed: 18715214
Tamborlane WV, Beck RW, Bode BW et al (2008) Continuous glucose monitoring and intensive treatment of type 1 diabetes. N Engl J Med 359(14):1464–1476. https://doi.org/10.1056/NEJMoa0805017
doi: 10.1056/NEJMoa0805017
pubmed: 18779236
Lagarde WH, Barrows FP, Davenport ML, Kang M, Guess HA, Calikoglu AS (2006) Continuous subcutaneous glucose monitoring in children with type 1 diabetes mellitus: a single-blind, randomized, controlled trial. Pediatr Diabetes 7(3):159–164. https://doi.org/10.1111/j.1399-543X.2006.00162.x
doi: 10.1111/j.1399-543X.2006.00162.x
pubmed: 16787523
Lind M, Polonsky W, Hirsch IB et al (2017) 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 317(4):379–387. https://doi.org/10.1001/jama.2016.19976
doi: 10.1001/jama.2016.19976
pubmed: 28118454
Mauras N, Beck R, Xing D et al (2012) 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. Diabetes Care 35(2):204–210. https://doi.org/10.2337/dc11-1746
doi: 10.2337/dc11-1746
pubmed: 22210571
pmcid: 3263860
O’Connell MA, Donath S, O’Neal DN et al (2009) Glycaemic impact of patient-led use of sensor-guided pump therapy in type 1 diabetes: a randomised controlled trial. Diabetologia 52(7):1250–1257. https://doi.org/10.1007/s00125-009-1365-0
doi: 10.1007/s00125-009-1365-0
pubmed: 19396424
Olivier P, Lawson ML, Huot C, Richardson C, Nakhla M, Romain J (2014) Lessons learned from a pilot RCT of simultaneous versus delayed initiation of continuous glucose monitoring in children and adolescents with type 1 diabetes starting insulin pump therapy. J Diabetes Sci Technol 8(3):523–528. https://doi.org/10.1177/1932296814524855
doi: 10.1177/1932296814524855
pubmed: 24876616
pmcid: 4455437
Raccah D, Sulmont V, Reznik Y et al (2009) Incremental value of continuous glucose monitoring when starting pump therapy in patients with poorly controlled type 1 diabetes: the RealTrend study. Diabetes Care 32(12):2245–2250. https://doi.org/10.2337/dc09-0750
doi: 10.2337/dc09-0750
pubmed: 19767384
pmcid: 2782985
Riveline JP, Schaepelynck P, Chaillous L et al (2012) Assessment of patient-led or physician-driven continuous glucose monitoring in patients with poorly controlled type 1 diabetes using basal-bolus insulin regimens: a 1-year multicenter study. Diabetes Care 35(5):965–971. https://doi.org/10.2337/dc11-2021
doi: 10.2337/dc11-2021
pubmed: 22456864
pmcid: 3329830
Sequeira PA, Montoya L, Ruelas V et al (2013) Continuous glucose monitoring pilot in low-income type 1 diabetes patients. Diabetes Technol Ther 15(10):855–858. https://doi.org/10.1089/dia.2013.0072
doi: 10.1089/dia.2013.0072
pubmed: 23865840
pmcid: 3781124
Tumminia A, Crimi S, Sciacca L et al (2015) 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 31(1):61–68. https://doi.org/10.1002/dmrr.2557
doi: 10.1002/dmrr.2557
pubmed: 24816997
New JP, Ajjan R, Pfeiffer AF, Freckmann G (2015) Continuous glucose monitoring in people with diabetes: the randomized controlled Glucose Level Awareness in Diabetes Study (GLADIS). Diabet Med 32(5):609–617. https://doi.org/10.1111/dme.12713
doi: 10.1111/dme.12713
pubmed: 25661981
van Beers CA, DeVries JH, Kleijer SJ et al (2016) 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 4(11):893–902. https://doi.org/10.1016/s2213-8587(16)30193-0
doi: 10.1016/s2213-8587(16)30193-0
pubmed: 27641781
Olafsdottir AF, Polonsky W, Bolinder J et al (2018) A randomized clinical trial of the effect of continuous glucose monitoring on nocturnal hypoglycemia, daytime hypoglycemia, glycemic variability, and hypoglycemia confidence in persons with type 1 diabetes treated with multiple daily insulin injections (GOLD-3). Diabetes Technol Ther 20(4):274–284. https://doi.org/10.1089/dia.2017.0363
doi: 10.1089/dia.2017.0363
pubmed: 29608107
pmcid: 5910048
Guilmin-Crepon S, Carel JC, Schroedt J et al (2019) Is there an optimal strategy for real-time continuous glucose monitoring in pediatrics? A 12-month French multi-center, prospective, controlled randomized trial (Start-In!). Pediatr Diabetes 20(3):304–313. https://doi.org/10.1111/pedi.12820
doi: 10.1111/pedi.12820
pubmed: 30663187
Kordonouri O, Hartmann R, Pankowska E et al (2012) Sensor augmented pump therapy from onset of type 1 diabetes: late follow-up results of the pediatric onset study. Pediatr Diabetes 13(7):515–518. https://doi.org/10.1111/j.1399-5448.2012.00863.x
doi: 10.1111/j.1399-5448.2012.00863.x
pubmed: 22487079
Bolinder J, Antuna R, Geelhoed-Duijvestijn P, Kroger J, Weitgasser R (2016) Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial. Lancet 388(10057):2254–2263. https://doi.org/10.1016/s0140-6736(16)31535-5
doi: 10.1016/s0140-6736(16)31535-5
pubmed: 27634581
Hermanides J, Norgaard K, Bruttomesso D et al (2011) Sensor-augmented pump therapy lowers HbA(1c) in suboptimally controlled Type 1 diabetes; a randomized controlled trial. Diabet Med 28(10):1158–1167. https://doi.org/10.1111/j.1464-5491.2011.03256.x
doi: 10.1111/j.1464-5491.2011.03256.x
pubmed: 21294770
Peyrot M, Rubin RR (2009) Patient-reported outcomes for an integrated real-time continuous glucose monitoring/insulin pump system. Diabetes Technol Ther 11(1):57–62. https://doi.org/10.1089/dia.2008.0002
doi: 10.1089/dia.2008.0002
pubmed: 19132857
Bergenstal RM, Tamborlane WV, Ahmann A et al (2010) Effectiveness of sensor-augmented insulin-pump therapy in type 1 diabetes. N Engl J Med 363(4):311–320. https://doi.org/10.1056/NEJMoa1002853
doi: 10.1056/NEJMoa1002853
pubmed: 20587585
Ly TT, Nicholas JA, Retterath A, Lim EM, Davis EA, Jones TW (2013) Effect of sensor-augmented insulin pump therapy and automated insulin suspension vs standard insulin pump therapy on hypoglycemia in patients with type 1 diabetes: a randomized clinical trial. JAMA 310(12):1240–1247. https://doi.org/10.1001/jama.2013.277818
doi: 10.1001/jama.2013.277818
pubmed: 24065010
Education effectiveness for type 1 diabetes mellitus on insulin pump therapy (EASEDIAP) [article online] (2016). https://clinicaltrials.gov/ct2/show/NCT02423993 . Accessed 07 Oct 2019
Babar GS, Ali O, Parton EA, Hoffmann RG, Alemzadeh R (2009) Factors associated with adherence to continuous subcutaneous insulin infusion in pediatric diabetes. Diabetes Technol Ther 11(3):131–137. https://doi.org/10.1089/dia.2008.0042
doi: 10.1089/dia.2008.0042
pubmed: 19216689
Pala L, Dicembrini I, Mannucci E (2019) Continuous subcutaneous insulin infusion vs modern multiple injection regimens in type 1 diabetes: an updated meta-analysis of randomized clinical trials. Acta Diabetol 56(9):973–980. https://doi.org/10.1007/s00592-019-01326-5
doi: 10.1007/s00592-019-01326-5
pubmed: 30945047
Brown S, Raghinaru D, Emory E, Kovatchev B (2018) First look at control-IQ: a new-generation automated insulin delivery system. Diabetes Care 41(12):2634–2636. https://doi.org/10.2337/dc18-1249
doi: 10.2337/dc18-1249
pubmed: 30305346
pmcid: 6245207
Zhong A, Choudhary P, McMahon C et al (2016) Effectiveness of automated insulin management features of the MiniMed((R)) 640G sensor-augmented insulin pump. Diabetes Technol Ther 18(10):657–663. https://doi.org/10.1089/dia.2016.0216
doi: 10.1089/dia.2016.0216
pubmed: 27672710
pmcid: 5111481
Aleppo G, Webb KM (2018) Integrated insulin pump and continuous glucose monitoring technology in diabetes care today: a perspective of real-life experience with the MiniMed() 670G hybrid closed-loop system. Endocr Pract 24(7):684–692. https://doi.org/10.4158/ep-2018-0097
doi: 10.4158/ep-2018-0097
pubmed: 30048171
Mancini G, Berioli MG, Santi E et al (2018) Flash glucose monitoring: a review of the literature with a special focus on type 1 diabetes. Nutrients. https://doi.org/10.3390/nu10080992
doi: 10.3390/nu10080992
pubmed: 30463330
pmcid: 6265864
Paris I, Henry C, Pirard F, Gerard AC, Colin IM (2018) The new FreeStyle libre flash glucose monitoring system improves the glycaemic control in a cohort of people with type 1 diabetes followed in real-life conditions over a period of one year. Endocrinol Diabetes Metab 1(3):e00023. https://doi.org/10.1002/edm2.23
doi: 10.1002/edm2.23
pubmed: 30815557
pmcid: 6354746
Haak T, Hanaire H, Ajjan R, Hermanns N, Riveline JP, Rayman G (2017) 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 8(1):55–73. https://doi.org/10.1007/s13300-016-0223-6
doi: 10.1007/s13300-016-0223-6
pubmed: 28000140
Dicembrini I, Mannucci E, Monami M, Pala L (2019) Impact of technology on glycaemic control in type 2 diabetes: a meta-analysis of randomized trials on continuous glucose monitoring and continuous subcutaneous insulin infusion. Diabetes Obes Metab 21(12):2619–2625. https://doi.org/10.1111/dom.13845
doi: 10.1111/dom.13845
pubmed: 31368658
Boscari F, Galasso S, Facchinetti A et al (2018) FreeStyle Libre and Dexcom G4 platinum sensors: accuracy comparisons during two weeks of home use and use during experimentally induced glucose excursions. Nutr Metab Cardiovasc Dis 28(2):180–186. https://doi.org/10.1016/j.numecd.2017.10.023
doi: 10.1016/j.numecd.2017.10.023
pubmed: 29258716
Reddy M, Jugnee N, El Laboudi A, Spanudakis E, Anantharaja S, Oliver N (2018) A randomized controlled pilot study of continuous glucose monitoring and flash glucose monitoring in people with Type 1 diabetes and impaired awareness of hypoglycaemia. Diabet Med 35(4):483–490. https://doi.org/10.1111/dme.13561
doi: 10.1111/dme.13561
pubmed: 29230878
Foster NC, Beck RW, Miller KM et al (2019) State of type 1 diabetes management and outcomes from the T1D exchange in 2016–2018. Diabetes Technol Ther 21(2):66–72. https://doi.org/10.1089/dia.2018.0384
doi: 10.1089/dia.2018.0384
pubmed: 30657336
pmcid: 7061293
Wan W, Skandari MR, Minc A et al (2018) Cost-effectiveness of initiating an insulin pump in T1D adults using continuous glucose monitoring compared with multiple daily insulin injections: the DIAMOND randomized trial. Med Decis Mak 38(8):942–953. https://doi.org/10.1177/0272989x18803109
doi: 10.1177/0272989x18803109