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.
CSII
clinical trial
continuous glucose monitoring (CGM)
Journal
Diabetes, obesity & metabolism
ISSN: 1463-1326
Titre abrégé: Diabetes Obes Metab
Pays: England
ID NLM: 100883645
Informations de publication
Date de publication:
08 2020
08 2020
Historique:
received:
30
01
2020
revised:
09
03
2020
accepted:
10
03
2020
pubmed:
14
3
2020
medline:
25
6
2021
entrez:
14
3
2020
Statut:
ppublish
Résumé
To investigate the efficacy of a combination of continuous glucose monitoring (CGM) and continuous subcutaneous insulin infusion (CSII) versus an optimized degludec-based multiple daily injections (MDI) regimen + self-monitoring of blood glucose (SMBG) in people with type 1 diabetes with regard to optimizing glucose control. The trial included 28 individuals who underwent a 4-week run-in phase, and were then randomized 1:1 to: (a) CSII + CGM followed by MDI + SMBG or (b) an MDI basal-bolus regimen followed by CSII + CGM. In patients randomized to the CSII + CGM → MDI + SMBG arm, a significant reduction in glycated haemoglobin (HbA1c) versus baseline was found at the end of the first phase (CSII + CGM) without significant variation in the following MDI + SMBG phase. In the arm randomized to the MDI + SMBG → CSII + CGM sequence, a significant improvement in HbA1c was observed in the first phase (MDI + SMBG), together with a further decrease in the following CSII + CGM phase. In the comparison of the two treatments using a mixed linear model, CSII + CGM was superior to MDI + SMBG with respect to change in HbA1c (P = 0.001). This study suggests that CSII + CGM improves glycaemic control without relevant safety issues in type 1 diabetes, in comparison with MDI + SMBG.
Substances chimiques
Blood Glucose
0
Glycated Hemoglobin A
0
Hypoglycemic Agents
0
Insulin
0
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1286-1291Subventions
Organisme : This trial was financially supported by Movi SpA. The funding source had no advising role in trial design details and drafting of the report. The funding source had no role in the conduct of the analyses, interpretation of the data or in the decision to approve publication
Pays : International
Informations de copyright
© 2020 John Wiley & Sons Ltd.
Références
Pala L, Dicembrini I, Mannucci E. Continuous subcutaneous insulin infusion vs modern multiple injection regimens in type 1 diabetes: an updated meta-analysis of randomized clinical trials. Acta Diabetol. 2019;56(9):973-980.
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 (Oxf). 2017 Mar;86(3):354-360.
Pickup JC, Freeman SC, Sutton AJ. Glycaemic control in type 1 diabetes during real time continuous glucose monitoring compared with self monitoring of blood glucose: meta-analysis of randomised controlled trials using individual patient data. BMJ. 2011;343:d3805.
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 Dec;55(12):3155-3162.
Beck RW, Riddlesworth TD, Ruedy KJ, et al. 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. 2017;5(9):700-708.
Bergenstal RM, Tamborlane WV, Ahmann A, et al. Effectiveness of sensor-augmented insulin-pump therapy in type 1 diabetes. N Engl J Med. 2010;363(4):311-320.
Hermanides J, Nørgaard K, Bruttomesso D, et al. Sensor-augmented pump therapy lowers HbA(1c) in suboptimally controlled type 1 diabetes; a randomized controlled trial. Diabet Med. 2011;28(10):1158-1167.
Šoupal J, Petruželková L, Flekač M, et al. Comparison of different treatment modalities for type 1 diabetes, including sensor-augmented insulin regimens, in 52 weeks of follow-up: a COMISAIR study. Diabetes Technol Ther. 2016;18(9):532-538.
Bergenstal RM, Bailey TS, Rodbard D, et al. Comparison of insulin glargine 300 units/mL and 100 units/mL in adults with type 1 diabetes: continuous glucose monitoring profiles and variability using morning or evening injections. Diabetes Care. 2017 Apr;40(4):554-560.
Birkeland KI, Home PD, Wendisch U, et al. Insulin Degludec in type 1 diabetes: a randomized controlled trial of a new-generation ultra-long-acting insulin compared with insulin glargine. Diabetes Care. 2011 Mar;34(3):661-665.
Bradley C. The diabetes treatment satisfaction questionnaire: DTSQ. In: Bradley C, ed. Handbook of Psychology and Diabetes: a Guide to Psychological Measurement in Diabetes Research and Practice. Chur, Switzerland: Harwood Academic Publishers; 1994:111-132.
Šoupal J, Petruželková L, Grunberger G, 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. 2020 Jan;43(1):37-43.
Hoogma RP, Hammond PJ, Gomis R, et al. Comparison of the effects of continuous subcutaneous insulin infusion (CSII) and NPH-based multiple daily insulin injections (MDI) on glycaemic control and quality of life: results of the 5-nations trial. Diabet Med. 2006;23(2):141-147.
DeVries JH, Snoek FJ, Kostense PJ, Masurel N, Heine RJ, Dutch Insulin Pump Study Group. A randomized trial of continuous subcutaneous insulin infusion and intensive injection therapy in type 1 diabetes for patients with long-standing poor glycemic control. Diabetes Care. 2002;25(11):2074-2080.
Hanaire-Broutin H, Melki V, Bessieres-Lacombe S, Tauber JP. Comparison of continuous subcutaneous insulin infusion and multiple daily injection regimens using insulin lispro in type 1 diabetic patients on intensified treatment. Diabetes Care. 2000;23(9):1232-1235.