Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial

The Lancet

Volumn 388, Issue 10057, 2016, Pages 2254-2263

  Bolinder, Jan ^a   Antuna, Ramiro ^b   Geelhoed Duijvestijn, Petronella ^c   Kröger, Jens ^d   Weitgasser, Raimund ^e,f  

^a KAROLINSKA UNIVERSITY HOSPITAL   (Sweden)

^b Clinidiabet   (Spain)

^c MEDICAL CENTER HAAGLANDEN   (Netherlands)

^d Centre for Diabetology Hamburg Bergedorf   (Germany)

^e Diakonissen Hospital   (Austria)

^f PARACELSUS MEDICAL UNIVERSITY   (Austria)

Author keywords

[No Author keywords available]

Indexed keywords

CHOLESTEROL; GLUCOSE; HEMOGLOBIN A1C; INSULIN; TRIACYLGLYCEROL; ANTIDIABETIC AGENT; GLUCOSE BLOOD LEVEL; GLYCOSYLATED HEMOGLOBIN;

ADULT; ALLERGY; ARTICLE; BLEEDING; BLOOD GLUCOSE MONITORING; CONTROLLED STUDY; EDEMA; ERYTHEMA; FEMALE; FLASH GLUCOSE MONITORING SYSTEM; GLUCOSE BLOOD LEVEL; GLUCOSE SENSOR; HOSPITAL READMISSION; HUMAN; HYPOGLYCEMIA; INSULIN DEPENDENT DIABETES MELLITUS; INSULIN INFUSION; MAJOR CLINICAL STUDY; MALE; MEDICAL DEVICE COMPLICATION; MULTICENTER STUDY; PAIN; PATIENT SATISFACTION; PRIORITY JOURNAL; PROSPECTIVE STUDY; PRURITUS; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RASH; TEST STRIP; TREATMENT OUTCOME; ANALYSIS; BLOOD; CLINICAL TRIAL; DIABETES MELLITUS, TYPE 1; DRUG ADMINISTRATION; INVENTION; METABOLISM; PHYSIOLOGIC MONITORING; PROCEDURES;

BLOOD GLUCOSE; DIABETES MELLITUS, TYPE 1; DRUG ADMINISTRATION SCHEDULE; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; HYPOGLYCEMIA; HYPOGLYCEMIC AGENTS; INSULIN; INVENTIONS; MONITORING, PHYSIOLOGIC;

EID: 84994553148     PISSN: 01406736     EISSN: 1474547X     Source Type: Journal    
DOI: 10.1016/S0140-6736(16)31535-5     Document Type: Article

References (35)

1. 1 The DCCT Research Group. Epidemiology of severe hypoglycemia in the diabetes control and complications trial. Am J Med 90 (1991), 450–459.
2. 2 Nathan, DM, Cleary, PA, Backlund, JY, et al., for Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study Research Group. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med 353 (2005), 2643–2653.
3. 3 The Diabetes Control and Complications Research Group. Hypoglycaemia in the diabetes, control and complications trial. Diabetes 46 (1997), 272–286.
4. 4 UK Hypoglycaemia Study Group. Risk of hypoglycaemia in types 1 and 2 diabetes: effects of treatment modalities and their duration. Diabetalogia 50 (2007), 1140–1147.
5. 5 Choudhary, P, Amiel, SA, Hypoglycaemia: current management and controversies. Postgrad Med J 87 (2011), 298–306.
6. 6 Cryer, PE, Diverse causes of hypoglycaemia-associated autonomic failure in diabetes. N Engl J Med 350 (2004), 2272–2279.
7. 7 Workgroup on Hypoglycemia, American Diabetes Association. Defining and reporting hypoglycemia in diabetes: a report from the American Diabetes Association Workgroup on Hypoglycemia. Diabetes Care 28 (2005), 1245–1249.
8. 8 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, 343, 2011, d3805.
9. 9 Bergenstal, RM, Tamborlane, WV, Ahmann, A, et al. Effectiveness of sensor-augmented insulin-pump therapy in type 1 diabetes. N Engl J Med 363 (2010), 311–320.
10. 10 Battelino, T, Conget, I, Olsen, B, et al., for the SWITCH Study Group. The use and efficacy of continuous glucose monitoring in type 1 diabetes treated with insulin pump therapy: a randomised controlled trial. Diabetologia 55 (2012), 3155–3162.
11. 11 Bergenstal, RM, Klonoff, DC, Garg, SK, et al., for the ASPIRE In-Home Study Group. Threshold-based insulin-pump interruption for reduction of hypoglycaemia. N Engl J Med 369 (2013), 224–232.
12. 12 Rodbard, D, Continuous glucose monitoring: a review of successes, challenges, and opportunities. Diabetes Technol Ther 18:suppl 2 (2016), S23–213.
13. 13 Abbott. FreeStyle Libre Software. http://www.FreeStyleLibre.com (accessed July 18, 2016).
14. 14 Polonsky, WH, Fisher, L, Earles, J, et al. Assessing psychosocial distress in diabetes: development of the Diabetes Distress Scale. Diabetes Care 28 (2005), 626–631.
15. 15 The DCCT Research Group. Reliability and validity of a diabetes quality-of-life measure for the diabetes control and complications trial (DCCT). Diabetes Care 11 (1988), 725–732.
16. 16 Bradley, C, Diabetes treatment satisfaction questionnaire. In: Bradley C (ed). Handbook of Psychology and Diabetes, 1994, Harwood Academic Publishers, Chur, Switzerland.
17. 17 Gonder-Frederick, LA, Schmidt, KM, Vajda, KA, et al. Psychometric properties of the hypoglycemia fear survey-ii for adults with type 1 diabetes. Diabetes Care 34 (2011), 801–806.
18. 18 Kovatchev, BP, Clarke, WL, Breton, M, Brayman, K, McCall, A, Quantifying temporal glucose variability in diabetes via continuous glucose monitoring: mathematical methods and clinical application. Diabetes Technol Ther 7 (2005), 849–862.
19. 19 Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group. The effect of continuous glucose monitoring in well-controlled type 1 diabetes. Diabetes Care 32 (2009), 1378–1383.
20. 20 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 34 (2011), 795–800.
21. 21 Pickup, JC, Ford Holloway, M, Samsi, K, Real-time continuous glucose monitoring in type 1 diabetes: a qualitative framework analysis of patient narratives. Diabetes Care 38 (2015), 544–550.
22. 22 Riveline, JP, Schaepelynck, P, Chaillous, L, et al., for the EVADIAC Sensor Study Group. 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 (2012), 965–971.
23. 23 Bolinder, J, Hagström-Toft, E, Ungerstedt, U, Arner, P, Self-monitoring of blood glucose in type I diabetic patients: comparison with continuous microdialysis measurements of glucose in subcutaneous adipose tissue during ordinary life conditions. Diabetes Care 20 (1997), 64–70.
24. 24 Hortensius, J, Kars, MC, Wierenga, WS, Kleefstra, N, Bilo, HJ, van der Bijl, JJ, Perspectives of patients with type 1 or insulin treated type 2 diabetes on self-monitoring of blood glucose: a qualitative study. BMC Public Health 12 (2012), 167–177.
25. 25 Alvarez-Guisasola, F, Yin, DD, Nocea, G, Qui, Y, Mavros, P, Association of hypoglycemic symptoms with patients’ rating of their health-related quality of life state: a cross sectional study. BMC Public Health, 8, 2010, 86.
26. 26 Polonsky, WH, Hassler, D, What are the quality of life-related benefits and losses associated with real-time continuous glucose monitoring? A survey of current users. Diabetes Technol Ther 15 (2013), 295–330.
27. 27 Bergenstal, RM, Tamborlane, WV, Ahmann, A, et al., for the STAR 3 Study Group. Sensor-augmented pump therapy for A1C reduction (STAR 3) study: results from the 6-month continuation phase. Diabetes Care 34 (2011), 2403–2405.
28. 28 Kovatchev, BP, Otto, E, Cox, D, Gonder-Frederick, L, Clarke, W, Evaluation of a new measure of blood glucose variability in diabetes. Diabetes Care 29 (2006), 2433–2438.
29. 29 Kilpatrick, ES, Rigby, AS, Goode, K, Atkin, SL, Relating mean blood glucose and glucose variability to the risk of multiple episodes of hypoglycaemia in type 1 diabetes. Diabetologia 50 (2007), 2553–2561.
30. 30 Schisano, B, Tripathi, G, McGee, K, McTernan, PG, Ceriello, A, Glucose oscillations, more than constant high glucose, induce activation and a metabolic memory in human endothelial cells. Diabetologia 54 (2011), 1219–1226.
31. 31 Khunti, K, Davies, M, Majeed, A, Thorsted, BL, Wolden, ML, Paul, SK, Hypoglycemia and risk of cardiovascular disease and all-cause mortality in insulin-treated people with type 1 and type 2 diabetes: a cohort study. Diabetes Care 38 (2015), 316–322.
32. 32 Kovatchev, BP, Cox, DJ, Farhy, LS, Straume, M, Gonder-Frederick, L, Clarke, WL, Episodes of severe hypoglycemia in type 1 diabetes are preceded and followed within 48 hours by measurable disturbances in blood glucose. J Clin Endocrinol Metab 85 (2000), 4287–4292.
33. 33 Choudhary, P, Olsen, BS, Conget, I, Welsh, JB, Vorrink, L, Shin, JJ, Hypoglycemia prevention and user acceptance of an insulin pump system with predictive low glucose management. Diabetes Technol Ther 18 (2016), 288–291.
34. 34 Pozzilli, P, Battelino, T, Danne, T, Hovorka, R, Jarosz-Chobot, P, Renard, E, Continuous subcutaneous insulin infusion in diabetes: patient populations, safety, efficacy, and pharmacoeconomics. Diabetes Metab Res Rev 32 (2016), 21–39.
35. 35 Maahs, DM, Buckingham, B, Castle, J, et al. Outcome measures for artificial pancreas clinical trials: a consensus report. Diabetes Care 39 (2016), 1175–1179.