Rationale and design of the multinational observational study assessing insulin use: the MOSAIc study

BMC Endocrine Disorders

Table 4 Outcome definitions for insulin progression, based on initial insulin therapy

Initial Insulin Therapy	Definition of Insulin Progression^a,b
Basal alone or in combination with any approved non-insulin anti-diabetic medications	Addition of prandial insulin (≥1 injection: basal plus or basal-bolus)
	Additional injections
	- QD to BID administration of NPH
	- Insulin glargine[Lantus]/Insulin levemir[Determir]
	- ILPS or insulin mixtures
	- Intermediate-acting NPH
	Mixtures
	- human/animal/analog premixed insulin (combination of short- and long-acting insulin in the same formulation)
	Addition of a GLP-1
	Addition of oral medications
Basal Insulin plus additional insulin therapy (less than a full basal-bolus regimen (basal + <3 prandial injections)) or in combination with any approved non-insulin anti-diabetic medications	Additional insulin injections (e.g., 1 to 2 injections, or 2 to 3 injections)
	Basal-bolus regimen
	Addition of a GLP-1
	Addition of oral medications
Insulin mixtures alone or in combination with any approved non-insulin anti-diabetic medications	Additional insulin injections (e.g., 1 to 2 injections, or 2 to 3 injections)
	Basal-bolus regimen
	Addition of a GLP-1
	Addition of oral medications

Abbreviations: BID = twice a day; GLP-1 = glucagon-like peptide 1; ILPS = insulin lispro protamine suspension; NPH = neutral protamine Hagedorn; QD = every day.
^aReferrals to a specialist (eg, endocrinologist) for progression of therapy will be captured.
^bFor the purpose of this study, progression will be defined as the first progression from initial therapy (as defined above).

ISSN: 1472-6823