Patient selection criteria for the U-500R Syringe Initiators [Index Event 1a]:
Include patients who had ≥1 prescription claim for U-500R vial during the identification period (VHA and LCED: 01JAN2014-30JUN2017; Truven: 01APR2014-30SEP2017)—the first prescription claim for U-500R vial will be designated as index Event 1a (U-500R syringe initiation), and the date will be designated as the index date;
Include patients who 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;
Exclude patients who had both T1DM and T2DM, had no oral anti-diabetic drug (OADs) other than metformin, and the ratio between the number of T1DM
and T2DM claims >0.5 at any time in the study period (VHA and LCED: 01APR2013-31MAR2018; Truven: 01JUL2013-30JUN2018);
Include patients who were aged ≥18 years on the index date;
Include patients who had continuous health plan enrollment with medical and pharmacy benefits for ≥9 months pre- and post-index event;
Exclude patients with no evidence of insulin including U-500R (any type; Table 2) in the 9 months pre-index period (baseline);
Exclude patients with ≥1 prescription claim for U-500R use in the 9 months pre-index period;
Include patients who had ≥1 prescription claim for any insulin other than U-500R in the 9-month pre-index period;
Include patients who had ≥1 HbA1c measurement within 90-day pre-index or 30-day post-index event;
Include patients who had ≥1 HbA1c measurement after the 30-day post-index period at any time in the 9-months follow-up period;
o Patients with ≥1 HbA1c measurement after the 30-day post-index and within 30 days prior to the end of the 9-months follow-up period will be flagged; and
o Patients with ≥1 HbA1c measurement after the 30-day post-index and within 2 months prior to the end of the 9-months follow-up period will be flagged;
Exclude patients who 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 9-month baseline period;
Exclude patients who had claims indicating pump use (Appendix 2) in the 9-month post-index (follow-up) period;
Exclude patients who had claims indicating TDD above 2000 units/day at any time in the pre-index or post-index periods.
Sample selection criteria for U-500R Kwikpen Initiators [Index Event 1b]
Include patients who had ≥1 prescription claim for U-500R Kwikpen administration during the identification period (VHA and LCED: 01JAN2014-30JUN2017; Truven: 01APR2014-30SEP2017)–the first prescription claim for U-500R Kwikpen administration will be designated as Index Event 1b, and the date will be designated as the index date;
Include patients who had ≥2 claim with an ICD-9/10-CM code for T2DM in any position (primary/secondary) at any timeprior to the index date;
Exclude patients who had both T1DM and T2DM, had no OADs other than metformin, and the ratio between the number of T1DM and T2DM claims >0.5 at
any time in the study period (VHA and LCED: 01APR2013-31MAR2018; Truven: 01JUL2013-30JUN2018);
Include patients who were aged ≥18 years on the index date;
Include patients who had continuous health plan enrollment with medical and pharmacy benefits for ≥9 months pre- and post-index event;
Exclude patients with no evidence of insulin including U-500R (any type) in the 9 months pre-index period (baseline);
Exclude patients with ≥1 prescription claim for U-500 use in the 9 months pre-index period;
Include patients who had ≥1 prescription claim for any insulin other than U-500R in the 9-month pre-index period;
Include patients who had ≥1 HbA1c measurement within 90-day pre-index or 30-day post-index event;
Include patients who had ≥1 HbA1c measurement after the 30-day post-index period at any time in the 9-months follow-up period;
o Patients with ≥1 HbA1c measurement after the 30-day post-index and within 30 days prior to the end of the 9-months follow-up period will be flagged; and
o Patients with ≥1 HbA1c measurement after the 30-day post-index and within 2 months prior to the end of the 9-months follow-up period will be flagged;
Exclude patients who 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 9-month baseline period;
Exclude patients who had evidence of pump use in the 9-month followup period;
Exclude patients who had claims indicating TDD above 2000 units/day at any time in the pre-index or post-index periods.
Sample Selection Criteria for U-500R Device Switchers from Syringe to Kwikpen [Index Event 2]
Include patients who had ≥1 claim for U-500R Kwikpen administration in the identification period (VHA and LCED: 01JAN2014-30JUN2017; Truven:
01APR2014-30SEP2017)–the first prescription claim for U-500R Kwikpen administration will be designated as the Index Event 2, and the date will be designated as the index date;
Include patients who had ≥2 claim with an ICD-9/10-CM code for T2DM in any position (primary/secondary) at any timeprior to the index date;
Exclude patients who had both T1DM and T2DM, had no OADs other than metformin, and the ratio between the number of T1DM and T2DM claims >0.5 at
any time in the study period (VHA and LCED: 01APR2013-31MAR2018; Truven: 01JUL2013-30JUN2018);
Include patients who were aged ≥18 years on the index date;
Include patients who had continuous health plan enrollment with medical and pharmacy benefits for ≥9 months pre- and post-index event;
Include patients who had ≥1 prescription claim for U-500R vial use in the 9-month baseline period;
Include patients who had ≥1 HbA1c measurement within 90-day pre-index event or 30-day post-index event; and
Include patients who had ≥1 HbA1c measurement after the 30-day post-index period;
o Patients with ≥1 HbA1c measurement after the 30-day post-index and within 30 days prior to the end of the 9-months follow-up period will be flagged; and
o Patients with ≥1 HbA1c measurement after the 30-day post-index and within 2 months prior to the end of the 9-months follow-up period will be flagged;
Exclude patients who had ≥1 claim for U-500R Kwikpen administration in the 9-month baseline period;
Exclude patients who 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 9-month baseline period;
Exclude patients who had claims indicating pump use in the identification period;
Exclude patients who had claims indicating TDD exceeding 2000 units/day at any time in the pre-index or post-index periods.