Hypoglycemia: Physician and Patient Perspectives

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01176656

Enrollment

800

Registered

2010-08-06

Start date

2010-09-30

Completion date

2010-12-31

Last updated

2011-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoglycemia, Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes Mellitus, Hypoglycemia

Brief summary

The purpose of this study is to assess the burden of hypoglycemia and identify unmet need related to the management of hypoglycemia among Type 2Diabetes Mellitus (T2DM) patients on OADs and/or insulin. This is an observational study which will identify patients with T2DM in an administrative claims database and will link claims data with results of patient and physician surveys concerning hypoglycemia.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* T2DM claims diagnosis (algorithm-based) with at least 2 pharmacy claims for an antidiabetic drug * at least 1 HbA1c test recorded during the identification period * continuous enrollment in the health plan for at least 12 months prior to survey date

Exclusion criteria

* Type 1 Diabetes Mellitus * pregnancy or gestational diabetes

Design outcomes

Primary

Measure	Time frame
prevalence of hypoglycemia and impact of hypoglycemia	October 2009-October 2010

Secondary

Measure	Time frame
Patient Reported Outcomes of Hypoglycemia (including fear, awareness, behavioral modification and recovery from hypoglycemia)	October 2009-October 2010
Treatment adherence and modification related to hypoglycemia, including health status, glycemic control and healthcare utilization	October 2009-October 2010

Outcome results