Clinical trial NCT02140645: Ascertainment of EMR-based Clinical Covariates Among Patients Receiving Oral and Non-insulin Injected Hypoglycemic Therapy
Official title: Association of Clinical Covariates With Non-insulin Diabetes Medication Initiation Using Electronic Medical Records (EMR)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2014-05-16
Enrollment: 166613
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: T2DM patients aged 18 or older, initiating antidiabetic treatment after at least 6 months of continuous enrollment

Brief summary: The objective of this study is to identify EMR-based clinical covariates and quantify their association with the prescribing of each specific type 2 diabetes (T2DM) medication under investigation. This will include an assessment of how well these covariates are captured through claims data proxies, and their potential to confound comparative research of T2DM medications.

Detailed description: Purpose:

Eligibility criteria: Inclusion criteria:

* Dispensing of an oral or non-insulin injected hypoglycemic medication between May 2011 and June 2012
* Diagnosis of type 2 diabetes mellitus
* Presence of electronic medical records (for the EMR-based subset)

Exclusion criteria:

* Age \<18 at T2DM medication initiation
* Missing or ambiguous age or sex information
* At least one diagnosis of type 1 diabetes mellitus
* Less than 6 months enrolment in the database preceding the date of the first dispensing
* Prior use of the index drug

Primary outcomes:
measure: Missing EMR (Electronic Medical Record) Characteristic: Smoking
timeFrame: Up to 20 months
measure: Missing EMR Characteristic: Duration of Diabetes
timeFrame: Up to 20 months
measure: Missing EMR Characteristic: Duration of Diabetes (Continuous)
timeFrame: Up to 20 months
measure: Missing EMR Characteristic: BMI (Body Mass Index)
timeFrame: Up to 20 months
measure: Missing EMR Characteristic: BMI (Continuous)
timeFrame: Up to 20 months
measure: Missing EMR Characteristic: HbA1c (Hemoglobin A1c (Glycosylated Hemoglobin))
timeFrame: Up to 20 months
measure: Missing EMR Characteristic: eGFR (Glomerular Filtration Rate)
timeFrame: Upto 20 months
measure: Missing EMR Characteristic: Total Cholesterol
timeFrame: Up to 20 months
measure: Missing EMR Characteristic: Systolic BP (Blood Pressure)
timeFrame: Up to 20 months
measure: Missing EMR Characteristic: Diastolic BP
timeFrame: Up to 20 months
measure: Binary EMR Characteristic: Neuropathy
timeFrame: Up to 20 months
measure: Binary EMR Characteristic: Nephropathy
timeFrame: Upto 20 months
measure: Binary EMR Characteristic: Retinopathy
timeFrame: Up to 20 months
measure: Binary EMR Characteristic: Pancreatitis
timeFrame: Up to 20 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Massachusetts
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: