Type 2 diabetes mellitus (T2DM) patients who utilized less ≤200 units/day of insulins either before or after U-500R exposure.
Patient Selection Criteria for the U-500R Syringe Initiators:
Inclusion criteria
Patient will be included in this cohort if they:
had ≥1 prescription claim for U-500R vial during the identification period (01JAN2014–30JUN2017), with the first prescription claim for U-500R vial designated as Index Event a (U-500R syringe initiation), and the date designated as the index date;
had ≥2 claims with an ICD-9/10-CM code (Appendix 1) for T2DM in any position (primary/secondary) at any time prior to the index date
were aged ≥18 years on the index date;
had continuous health plan enrollment with medical and pharmacy benefits for ≥9 months pre- and post-index event;
had ≥1 prescription claim for any insulin other than U-500R in the 9-month pre-index period;
had ≥1 HbA1c measurement within 90 days pre-index or 30 days post-index event;
had ≥1 HbA1c measurement after the 30-day post-index period at any time in the 9-month follow-up period; and
Exclusion criteria
Patient will be excluded in this cohort if they:
had both T1DM and T2DM, had no oral anti-diabetic drug (OADs; Appendix 1) other than metformin, with the ratio between the number of T1DM and T2DM claims >0.5 at any time in the study period (01APR2013–31MAR2018).
had previous use of U-500R in the 9-month pre-index period;
had ≥1 claim with an ICD-9/10-CM code (Appendix 1) for secondary diabetes, gestational diabetes, diabetes complicating pregnancy, childbirth, puerperium, or nonclinical diabetes at any time during the 9-month pre-index period;
had claims indicating pump use (Appendix 2) in the 9-month post-index (follow-up) period;
had claims indicating TDD above 2000 units/day at any time in the pre-index or postindex periods; or
had TDD >200 units/day both in the pre- and post-index periods
Patient Selection Criteria for U-500R Kwikpen Initiators:
Inclusion criteria
Patient will be included in this cohort if they:
had ≥1 prescription claim for U-500R Kwikpen administration during the identification period (01JAN2014–30JUN2017), with the first prescription claim for
U-500R Kwikpen administration designated as Index Event b, and the date designated as the index date;
had ≥2 claims with an ICD-9/10-CM code (Appendix 1) for T2DM in any position (primary/secondary) at any time prior to the index date;
were aged ≥18 years on the index date;
had continuous health plan enrolment with medical and pharmacy benefits for ≥9 months pre- and post-index event;
had ≥1 prescription claim for any insulin other than U-500R (Table 1) in the 9-month pre-index period;
had ≥1 HbA1c measurement within 90 days pre-index or 30 days post-index event; and
had ≥1 HbA1c measurement after the 30-day post-index period at any time in the 9-month post-index period.
Exclusion criteria
Patient will be excluded in this cohort if they:
had both T1DM and T2DM, had no OADs (Appendix 1) other than metformin, with
the ratio between the number of T1DM and T2DM claims >0.5 at any time in the study
period (01APR2013–31MAR2018);
had previous use of U-500R in the 9-month pre-index period;
had ≥1 claim with an ICD-9/10-CM code (Appendix 1) for secondary diabetes,
gestational diabetes, diabetes complicating pregnancy, childbirth, puerperium, or nonclinical diabetes at any time during the 9-month pre-index period;
had evidence of pump use (Appendix 2) in the 9-month post-index period;
had claims indicating TDD above 2000 units/day at any time in the pre-index or postindex periods; or
had TDD >200 units/day in the 9 months pre- and post-index periods.
Patient Selection Criteria for any U-500R Initiators:
Inclusion criteria
Patient will be included in this cohort if they:
had ≥1 prescription claim for U-500R syringe/Kwikpen administration during the identification period (01JAN2014–30JUN2017), with the first prescription claim for U-500R syringe or Kwikpen administration designated as Index Event c, and the date designated as the index date;
had ≥2 claims with an ICD-9/10-CM code (Appendix 1) for T2DM in any position (primary/secondary) at any time prior to the index date;
were aged ≥18 years on the index date;
had continuous health plan enrollment with medical and pharmacy benefits for ≥9 months pre- and post-index event;
had ≥1 prescription claim for any insulin other than U-500R (Table 1) in the 9-month pre-index period;
had ≥1 HbA1c measurement within 90 days pre-index or 30 days post-index event; and
had ≥1 HbA1c measurement after the 30-day post-index period at any time in the 9-month post-index period.
Exclusion criteria
Patient will be excluded in this cohort if they:
had both T1DM and T2DM, had no OADs (Appendix 1) other than metformin, with the ratio between the number of T1DM and T2DM claims >0.5 at any time in the study period (01APR2013-31MAR2018);
had previous use of U-500R in the 9-month pre-index period;
had ≥1 claim with an ICD-9/10-CM code (Appendix 1) for secondary diabetes, gestational diabetes, diabetes complicating pregnancy, childbirth, puerperium, or nonclinical diabetes at any time during the 9-month pre-index period;
had evidence of pump use (Appendix 2) in the 9-month post-index period;
had claims indicating TDD above 2000 units/day at any time in the pre-index or postindex periods; or
had TDD >200 units/day in the pre- and post-index periods.
Patient Selection Criteria for U-500R Device Switchers from Syringe to Kwikpen
Inclusion criteria
Patient will be included in this cohort if they:
had ≥1 claim for U-500R Kwikpen administration in the identification period (01JAN2014–30JUN2017), with the first prescription claim for U-500R Kwikpen administration designated as Index Event 2, and the date designated as the index date;
had ≥2 claims with an ICD-9/10-CM code (Appendix 1) for T2DM in any position (primary/secondary) at any time prior to the index date;
were aged ≥18 years on the index date;
had continuous health plan enrollment with medical and pharmacy benefits for ≥9 months pre- and post-index event;
had ≥1 prescription claim for U-500R vial use in the 9-month pre-index period;
had ≥1 HbA1c measurement within 90 days pre-index event or 30 days post-index event; and
had ≥1 HbA1c measurement after the 30-day post-index period.
Exclusion criteria
Patient will be excluded in this cohort if they:
had both T1DM and T2DM, had no OADs (Appendix 1) other than metformin, with the ratio between the number of T1DM and T2DM claims >0.5 at any time in the study period (01APR2013–31MAR2018);
had previous use of U-500R Kwikpen administration in the 9-month pre-index period;
had ≥1 claim with an ICD-9/10-CM code (Appendix 1) for secondary diabetes, gestational diabetes, diabetes complicating pregnancy, childbirth, puerperium, or nonclinical diabetes at any time during the 9-month pre-index period;
had claims indicating pump use (Appendix 2) in the 9-month post-index period;
had claims indicating TDD exceeding 2000 units/day at any time in the pre-index or post-index periods; or
had TDD >200 units/day in the pre- and post-index periods.