U-500R Syringe Initiators [Index Event a]
Inclusion Criteria
Patient will be included if they:
had ≥1 prescription claim for U-500R vial during the identification period (VHA: 01JAN2014–30JUN2017; Truven: 01JUL2014–30JUN2017), 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 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 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 post-index period;
had claims indicating TDD >180 in the post-index period;
had claims indicating TDD >180 in the pre-index period; and
Exclusion Criteria
Patient will be excluded if they:
had both T1DM and T2DM, had no oral anti-diabetic drug (OADs; Appendix 1) other than metformin, and the ratio between the number of T1DM and T2DM claims >0.5 at any time in the study period (VHA: 01APR2013–31MAR2018; Truven: 01JUL2013–30JUN2018);
had previous use of U-500R in the 9-month pre-index period;
had ≥1 claim with an ICD-9/10-CM code for secondary diabetes, gestational diabetes, diabetes complicating pregnancy, childbirth, puerperium, or non-clinical diabetes at any time during the 9-month pre-index period;
had claims indicating pump use 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 post-index periods; or
had claims indicating insulin use other than U-500R in the post-index period.
U-500R Kwikpen Initiators [Index Event b]
Inclusion Criteria
Patient will be included if they:
had ≥1 prescription claim for U-500R Kwikpen administration during the identification period (VHA: 01JAN2014–30JUN2017; Truven: 01JUL2014–30JUN2017), 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 claim with an ICD-9/10-CM code 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 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 followup period;
had claims indicating TDD >180 in the post-index period;
had claims indicating TDD >180 in the pre-index period; and
Exclusion Criteria
Patient will be excluded if they:
had both T1DM and T2DM, had no OADs other than metformin, with the ratio between the number of T1DM and T2DM claims >0.5 at any time in the study period (VHA: 01APR2013–31MAR2018; Truven: 01JUL2013–30JUN2018);
had previous use of U-500R in the 9-month pre-index period;
had ≥1 claim with a ICD-9/10-CM code (Appendix 1) for secondary diabetes, gestational diabetes, diabetes complicating pregnancy, childbirth, puerperium, or non-clinical diabetes at any time during the pre-index period;
had evidence of pump use in the post-index period;
had claims indicating TDD above 2000 units/day at any time in the pre-index or post-index periods; or
had claims indicating insulin use other than U-500R in the post-index period.
Sample selection criteria for any U-500R Initiators [Index Event c]
Inclusion Criteria
Patient will be included if they:
had ≥1 prescription claim for U-500R syringe or Kwikpen administration during the identification period (VHA: 01JAN2014–30JUN2017; Truven: 01JUL2014– 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 claim with an ICD-9/10-CM code 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 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 followup period;
had claims indicating TDD >180 in the post-index period; and
had claims indicating TDD >180 in the pre-index period
Exclusion Criteria
Patient will be excluded if they:
had both T1DM and T2DM, had no OADs other than metformin, with the ratio between the number of T1DM and T2DM claims >0.5 at any time in the study period (VHA: 01APR2013–31MAR2018; Truven: 01JUL2013–30JUN2018);
had previous use of U-500R in the 9-month pre-index period;
had ≥1 claim with a ICD-9/10-CM code for secondary diabetes, gestational diabetes, diabetes complicating pregnancy, childbirth, or puerperium, or non-clinical diabetes at any time during the pre-index period;
had evidence of pump use in the follow-up period;
had claims indicating TDD above 2000 units/day at any time in the pre-index or post-index periods; or
had claims indicating insulin use other than U-500R in the post-index period.