Continuous glucose monitoring detected hypoglycaemia in the Treating to Target in Type 2 Diabetes Trial (4-T)

for the 4-T Study Group

Research output: Contribution to journalArticlepeer-review

20 Scopus citations

Abstract

Aims Hypoglycaemia is a significant risk in insulin treated type 2 diabetes and has been associated with future risk of cardiovascular events. We compared the frequency of low-glucose events using continuous glucose monitoring (CGM) with that of self-reported hypoglycemic events at the end of the first and third years of the Treating to Target in Type 2 Diabetes Trial (4-T), which compared biphasic, prandial and basal insulin regimens added to sulfonylurea and metformin. Methods CGM using a Medtronic Gold system was performed in a subgroup of 4-T participants. CGM detected low-glucose events were defined at thresholds of ≤3.0 (CGM3.0) and ≤2.2 (CGM2.2) mmol/l. Results Of the 110 participants, 106 and 70 had CGM analysable data at the end of years 1 and 3 respectively. In both years, the frequency of CGM detected low glucose events was several fold higher than that of self-reported hypoglycaemia (symptoms with blood glucose less than 3.1 mmol/l [<56 mg/dl]). At the end of the first year, CGM3.0 and CGM2.2 mean (95%CI) event frequencies, expressed at events per participant per year, were 120 (85, 155) and 41 (21, 61) compared with 17 (8, 29) self-reported events during CGM, each p = 0.001. The disparity at the end of the third year was similar. Conclusions These data demonstrate the likely under-reporting of hypoglycaemia and of potential hypoglycaemia unawareness in clinical trials. The clinical implications of these findings need to be explored further (ISRCTN No ISRCTN51125379).

Original languageEnglish
Pages (from-to)161-168
Number of pages8
JournalDiabetes Research and Clinical Practice
Volume131
DOIs
StatePublished - Sep 2017
Externally publishedYes

Bibliographical note

Publisher Copyright:
© 2017

Funding

Dr. Levy has acted on advisory boards for Lilly, Novo Nordisk and Novartis. Professor Melanie Davies has acted as consultant, advisory board member and speaker for Novo Nordisk, Sanofi-Aventis, Lilly, Merck Sharp & Dohme, Boehringer Ingelheim, AstraZeneca and Janssen and as a speaker for Mitsubishi Tanabe Pharma Corporation. She has received grants in support of investigator and investigator initiated trials from Novo Nordisk, Sanofi-Aventis and Lilly. Professor Holman reports receiving grant support from Bayer, AstraZeneca, MSD and consulting fees from Amgen, Elcelyx, MSD, Novartis, Novo Nordisk.

FundersFunder number
AstraZeneca
Novartis
Sanofi
Boehringer Ingelheim
Novo Nordisk

    Keywords

    • Clinical trials
    • Continuous glucose monitoring
    • Hypoglycaemia
    • Insulin therapy
    • Type 2 diabetes

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