Observational, Cross-sectional Multicenter Study to Characterize and to Determine the Proportion of Ambulatory Type 2 Diabetes Mellitus Patients with Mild to Moderate Hypoglycemia Episodes according to their background therapy in Portugal; HypoglycemIa in POrtugal Study – PHARMAcy (HIPOS-PHARMA)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Medical condition to be studied:
  Type 2 diabetes mellitus

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  1740

Study design details

• Main study objective:
  Primary objectives:To characterize and to determine the proportion of ambulatory Type 2 Diabetes Mellitus patients with mild to moderate hypoglycemia episodes in Portugal treated with AHA.
• Outcomes:
  Primary outcomes: Proportion of mild to moderate hypoglycemic episodes in ambulatory patients treated with AHA. Secondary outcomes: 1) Socio-demographic (gender, age, educational level, employment status, marital status, co-residence status) and self-reported clinical information (including, BMI, co-morbidities, concomitant medication, duration of disease), 2) Healthcare resources consumption and patient days of work/school lost associated with mild to moderate hypoglycemic' episodes.
• Data analysis plan:
  Discrete variables will be summarized by absolute and relative counts. Percentages will be calculated using the number of participants for whom data will be available and missing values will be stated. Continuous variables will be summarized using central tendency (mean, median) and dispersion measures (standard deviation and inter-quartile range).The comparison between participants and refusals regarding basic socio-demographic characteristics (age group, gender, specialty and location of the prescribing physician) will be performed through the Chi-Square test or Fisher Exact test (if applicable).Descriptive statistics will adopt a 95% confidence interval. Logistic Regression will be used to explore factors that potentially may contribute to mild to moderate hypoglycemic episodes. Odds Ratio will be calculated for each significant association, using 95% confidence intervals.

Documents

Study publications

Bramlage P, Gitt AK, Binz C, Krekler M, Deeg E, Tschöpe D. Oral antidiabetic tr…

Walz L, Pettersson B, Rosenqvist U, Deleskog A, Journath G, Wändell P. Impact o…

Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E, Nauck M, Peters A…

Childs BP, Clark NG, Cox DJ, Cryer PE. Defining and reporting hypoglycemia in d…