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. 2018 Feb 13;18(1):9.
doi: 10.1186/s12902-018-0238-2.

An international survey on hypoglycemia among insulin-treated type I and type II diabetes patients: Turkey cohort of the non-interventional IO HAT study

Rıfat Emral  1 , Tamer Tetiker  2 , Ibrahim Sahin  3 , Ramazan Sari  4 , Ahmet Kaya  5 , İlhan Yetkin  6 , Sefika Uslu Cil  7 , Neslihan Başcıl Tütüncü  8 ; IO HAT investigator group
Affiliations

An international survey on hypoglycemia among insulin-treated type I and type II diabetes patients: Turkey cohort of the non-interventional IO HAT study

Rıfat Emral et al. BMC Endocr Disord. .

Abstract

Background: Limited real-world data are currently available on hypoglycemia in diabetes patients. The International Operations Hypoglycemia Assessment Tool (IO HAT) study was designed to estimate hypoglycemia in insulin-treated type I (T1DM) and type II (T2DM) diabetes mellitus patients from 9 countries. The data from Turkey cohort are presented here.

Methods: A non-interventional study to determine the hypoglycemia incidence, retrospectively and prospectively, in Turkish T1DM and T2DM patients using a 2-part self-assessment questionnaire.

Results: Overall, 2348 patients were enrolled in the Turkey cohort (T1DM = 306 patients, T2DM = 2042 patients). In T1DM patients, 96.8% patients reported hypoglycemic events (Incidence rate [IR]: 68.6 events per patient-year [ppy]), prospectively, while 74.0% patients reported hypoglycemic events (IR: 51.7 events ppy), retrospectively. In T2DM patients, 95.9% patients (IR: 28.3 events ppy) reported hypoglycemic events, prospectively, while 53.6% patients (IR: 23.0 events ppy) reported hypoglycemic events, retrospectively. Nearly all patients reported hypoglycemia during the prospective period.

Conclusions: This is a first patient-reported dataset on hypoglycemia in Turkish, insulin-treated diabetes patients. A high incidence of patient-reported hypoglycemia confirms that hypoglycemia remains under-estimated. Hypoglycemia increased healthcare utilization impacting patients' quality of life. Hypoglycemia remains a common side effect with insulin-treatment and strategies to optimize therapy and reduce hypoglycemia occurrence in diabetes patients are required.

Trial registration: Clinicaltrials.gov, NCT02306681 (Date of registration: 12 Nov 2014; retrospectively registered).

Keywords: Diabetes; Hypoglycemia; IO HAT; Insulin; Non-interventional; Turkey.

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Conflict of interest statement

Ethics approval and consent to participate

Istanbul University Cerrahpasa Medical Faculty Clinical Trial Ethics Committee (Nb:83,045,809/604.01/02-42,378) approved this study. All patients provided written informed consent.

Consent for publication

Not applicable.

Competing interests

RE: Speaker fees from Novo Nordisk, MSD, AstraZeneca, Boehringer, Sanofi; participation in advisory boards from Novo Nordisk, Sanofi, AstraZeneca.

TT: Speaker fees from Gen Pharmaceuticals, Novartis, Lilly, Novo Nordisk, MSD, AstraZeneca, Boehringer, Sanofi, Bilim; participation in advisory boards from Novo Nordisk, Sanofi, Lilly.

IS: Speaker fees from Novo Nordisk, MSD, AstraZeneca, Boehringer, Sanofi, Lilly and Novartis; participation in advisory boards from Sanofi, Lilly, Novo Nordisk and AstraZeneca.

RS: Speaker fees from Novo Nordisk, MSD, AstraZeneca, Boehringer, Sanofi, Lilly, Novartis; participation in advisory boards from Sanofi, AstraZeneca.

AK: Speaker fees from Novo Nordisk, AstraZeneca, Boehringer, Sanofi, Lilly, Novartis; participation in advisory boards from Sanofi, AstraZeneca, NovoNordisk.

IY: Speaker fees from Novo Nordisk, AstraZeneca, Boehringer, Sanofi, Novartis, Lilly; participation in advisory boards from Novo Nordisk, Sanofi, AstraZeneca.

SC: Employee of Novo Nordisk.

NT: Speaker fees from Novo Nordisk, MSD, AstraZeneca, Boehringer, Sanofi, Novartis, Lilly; participation in advisory boards from Novo Nordisk, Sanofi, AstraZeneca.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
IO HAT Study design. Severe hypoglycemia: an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions; Non-severe hypoglycemia: documented symptomatic (symptoms and blood glucose measurement ≤3.9 mmol/L [70 mg/dL]) and probable symptomatic (symptoms only). NSH = non-severe hypoglycemia; SH = severe hypoglycemia; SAQ = self-assessment questionnaire
Fig. 2
Fig. 2
Estimated rate of retrospective and prospective hypoglycemia in T1DM (any, nocturnal, and severe hypoglycemia). ‘Any’ and ‘Nocturnal’ based on 4-week period for both retrospective and prospective analyses. *Retrospective data based on 6-month period and prospective data based on 4-week period. RR = rate ratio; T1DM = type I diabetes mellitus
Fig. 3
Fig. 3
Estimated rate of retrospective and prospective hypoglycemia in T2DM (any, nocturnal, and severe hypoglycemia). ‘Any’ and ‘Nocturnal’ based on 4-week period for both retrospective and prospective analyses. *Retrospective data based on 6-month period and prospective data based on 4-week period. RR = rate ratio; T2DM = type II diabetes mellitus
Fig. 4
Fig. 4
Estimated rate of any hypoglycemic event by insulin regimen in T1DM. Data based on 4-week period for both retrospective and prospective analyses. S + L = short-acting and long-acting insulin; T1DM = type I diabetes mellitus; n = number of patients
Fig. 5
Fig. 5
Estimated rate of any hypoglycemic event by insulin regimen in T2DM. Data based on 4-week period for both retrospective and prospective analyses. S + L = short-acting and long-acting insulin; T2DM = type 2 diabetes mellitus; n = number of patients
Fig. 6
Fig. 6
Relationship between HbA1c and number of events – any hypoglycemic event in T1DM. a Proportion of patients experiencing any hypoglycemia during the retrospective and prospective periods, stratified by HbA1c levels at baseline b Scatter plot with regression line and 95% confidence interval for relationship between HbA1c at baseline and log-transformed number of events for patients experiencing any hypoglycemia before or after baseline. HbA1c = hemoglobin A1c; T1DM = type I diabetes mellitus
Fig. 7
Fig. 7
Relationship between HbA1c and number of events – any hypoglycemic event in T2DM. a Proportion of patients experiencing any hypoglycemia during the retrospective and prospective periods, stratified by HbA1c levels at baseline b Scatter plot with regression line and 95% confidence interval for relationship between HbA1c at baseline and log-transformed number of events for patients experiencing any hypoglycemia before or after baseline. HbA1c = hemoglobin A1c; T2DM = type I diabetes mellitus
Fig. 8
Fig. 8
Estimated rate of any hypoglycemic event by glucose monitoring frequency in T1DM and T2DM patients. Percentages represent percent of patients with hypoglycemia in each quartile. PPY = per patient-year; T1DM = type 1 diabetes mellitus; T2DM = type 2 diabetes mellitus
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