PMID- 37700692
OWN - NLM
STAT- MEDLINE
DCOM- 20231113
LR  - 20240323
IS  - 1463-1326 (Electronic)
IS  - 1462-8902 (Print)
IS  - 1462-8902 (Linking)
VI  - 25
IP  - 12
DP  - 2023 Dec
TI  - Severe (level 3) hypoglycaemia occurrence in a real-world cohort of adults with 
      type 1 or 2 diabetes mellitus (iNPHORM, United States).
PG  - 3736-3747
LID - 10.1111/dom.15268 [doi]
AB  - AIMS: Among adults with insulin- and/or secretagogue-treated diabetes in the 
      United States, very little is known about the real-world descriptive epidemiology 
      of iatrogenic severe (level 3) hypoglycaemia. Addressing this gap, we collected 
      primary, longitudinal data to quantify the absolute frequency of events as well 
      as incidence rates and proportions. MATERIALS AND METHODS: iNPHORM is a US-wide, 
      12-month ambidirectional panel survey (2020-2021). Adults with type 1 diabetes 
      mellitus (T1DM) or insulin- and/or secretagogue-treated type 2 diabetes mellitus 
      (T2DM) were recruited from a probability-based internet panel. Participants 
      completing >/=1 follow-up questionnaire(s) were analysed. RESULTS: Among 978 
      respondents [T1DM 17%; mean age 51 (SD 14.3) years; male: 49.6%], 63% of level 3 
      events were treated outside the health care system (e.g. by 
      family/friend/colleague), and <5% required hospitalization. Following the 
      12-month prospective period, one-third of individuals reported >/=1 event(s) [T1DM 
      44.2% (95% CI 36.8%-51.8%); T2DM 30.8% (95% CI 28.7%-35.1%), p = .0404, 
      alpha = 0.0007]; and the incidence rate was 5.01 (95% CI 4.15-6.05) events per 
      person-year (EPPY) [T1DM 3.57 (95% CI 2.49-5.11) EPPY; T2DM 5.29 (95% CI 
      4.26-6.57) EPPY, p = .1352, alpha = 0.0007]. Level 3 hypoglycaemia requiring 
      non-transport emergency medical services was more common in T2DM than T1DM (p < 
      .0001, alpha = 0.0016). In total, >90% of events were experienced by <15% of 
      participants. CONCLUSIONS: iNPHORM is one of the first long-term, prospective 
      US-based investigations on level 3 hypoglycaemia epidemiology. Our results 
      underscore the importance of participant-reported data to ascertain its burden. 
      Events were alarmingly frequent, irrespective of diabetes type, and concentrated 
      in a small subsample.
CI  - (c) 2023 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & 
      Sons Ltd.
FAU - Ratzki-Leewing, Alexandria
AU  - Ratzki-Leewing A
AUID- ORCID: 0000-0002-9474-7900
AD  - Department of Epidemiology and Biostatistics, Schulich School of Medicine and 
      Dentistry, Western University, London, Ontario, Canada.
AD  - Department of Family Medicine, Schulich School of Medicine and Dentistry, Western 
      University, London, Ontario, Canada.
FAU - Black, Jason E
AU  - Black JE
AUID- ORCID: 0000-0002-3762-3231
AD  - Department of Family Medicine, Schulich School of Medicine and Dentistry, Western 
      University, London, Ontario, Canada.
FAU - Kahkoska, Anna R
AU  - Kahkoska AR
AUID- ORCID: 0000-0003-2701-101X
AD  - Department of Nutrition, Gillings School of Global Public Health, University of 
      North Carolina, Chapel Hill, North Carolina, USA.
FAU - Ryan, Bridget L
AU  - Ryan BL
AUID- ORCID: 0000-0001-9080-5635
AD  - Department of Epidemiology and Biostatistics, Schulich School of Medicine and 
      Dentistry, Western University, London, Ontario, Canada.
AD  - Department of Family Medicine, Schulich School of Medicine and Dentistry, Western 
      University, London, Ontario, Canada.
FAU - Zou, Guangyong
AU  - Zou G
AUID- ORCID: 0000-0001-5773-4185
AD  - Department of Epidemiology and Biostatistics, Schulich School of Medicine and 
      Dentistry, Western University, London, Ontario, Canada.
AD  - Robarts Research Institute, Western University, London, Ontario, Canada.
FAU - Klar, Neil
AU  - Klar N
AUID- ORCID: 0000-0002-4996-6936
AD  - Department of Epidemiology and Biostatistics, Schulich School of Medicine and 
      Dentistry, Western University, London, Ontario, Canada.
FAU - Timcevska, Kristina
AU  - Timcevska K
AUID- ORCID: 0000-0001-9365-772X
AD  - Department of Family Medicine, Schulich School of Medicine and Dentistry, Western 
      University, London, Ontario, Canada.
FAU - Harris, Stewart B
AU  - Harris SB
AUID- ORCID: 0000-0002-1794-6551
AD  - Department of Epidemiology and Biostatistics, Schulich School of Medicine and 
      Dentistry, Western University, London, Ontario, Canada.
AD  - Department of Family Medicine, Schulich School of Medicine and Dentistry, Western 
      University, London, Ontario, Canada.
AD  - Department of Medicine/Division of Endocrinology, Schulich School of Medicine and 
      Dentistry, Western University, London, Ontario, Canada.
LA  - eng
GR  - KL2 TR002490/TR/NCATS NIH HHS/United States
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20230913
PL  - England
TA  - Diabetes Obes Metab
JT  - Diabetes, obesity & metabolism
JID - 100883645
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Secretagogues)
RN  - 0 (Insulin)
RN  - 0 (Insulin, Regular, Human)
RN  - Diabetes Mellitus, Insulin-Dependent, 2
SB  - IM
MH  - Humans
MH  - Adult
MH  - Male
MH  - United States/epidemiology
MH  - Middle Aged
MH  - *Diabetes Mellitus, Type 1/complications/drug therapy/epidemiology
MH  - *Diabetes Mellitus, Type 2/complications/drug therapy/epidemiology
MH  - Hypoglycemic Agents/adverse effects
MH  - Prospective Studies
MH  - Secretagogues
MH  - *Hypoglycemia/chemically induced/epidemiology/therapy
MH  - Insulin/adverse effects
MH  - Insulin, Regular, Human
PMC - PMC10958739
MID - NIHMS1971200
OTO - NOTNLM
OT  - hypoglycaemia
OT  - insulin secretagogue
OT  - insulin therapy
OT  - real-world evidence
OT  - type 1 diabetes
OT  - type 2 diabetes
COIS- CONFLICT OF INTEREST STATEMENT Alexandria Ratzki-Leewing: Sanofi global: grant, 
      member advisory board, fees paid for presentations; Sanofi Canada: fees paid for 
      presentations; Abbott: consultant, fees paid for presentations; Eli Lilly: 
      consultant, fees paid for presentations; Dexcom: consultant; Novo Nordisk: 
      consultant. Jason E. Black, Anna R. Kahkoska, Bridget L. Ryan, Guangyong Zou, 
      Neil Klar, and Kristina Timcevska have nothing to disclose. Stewart B. Harris: 
      Sanofi: grant, member advisory board, fees paid for presentations, consultant; 
      Eli Lilly: grant, member advisory board, consultant, clinical studies; Novo 
      Nordisk: grant, member advisory board, consultant, clinical studies; Janssen: 
      grant, member advisory board, consultant; AstraZeneca: grant, member advisory 
      board, consultant, clinical studies; Abbott: grant, membery advisory board, 
      consultant; Dexcom: consultant; Boehringer Ingelheim: grant, member advisory 
      board, consultant, clinical studies.
EDAT- 2023/09/13 06:42
MHDA- 2023/11/13 06:42
PMCR- 2024/03/22
CRDT- 2023/09/13 03:34
PHST- 2023/08/17 00:00 [revised]
PHST- 2023/02/28 00:00 [received]
PHST- 2023/08/18 00:00 [accepted]
PHST- 2023/11/13 06:42 [medline]
PHST- 2023/09/13 06:42 [pubmed]
PHST- 2023/09/13 03:34 [entrez]
PHST- 2024/03/22 00:00 [pmc-release]
AID - 10.1111/dom.15268 [doi]
PST - ppublish
SO  - Diabetes Obes Metab. 2023 Dec;25(12):3736-3747. doi: 10.1111/dom.15268. Epub 2023 
      Sep 13.