Insulin therapy in type 2 diabetes: Insights into clinical efficacy, patient-reported outcomes, and adherence challenges

Table 3 Studies comparing premixed and basal-bolus regimens in term of patient-reported outcomes

Result	Type of insulin therapy	Study design	PROMs	Comment	Ref.
Favor basal bolus therapy	Glargine + glulisine (BB) vs lispromix or aspartmix (PM)	Comparative 12 wk intervention (crossover) phases	Validated generic and diabetes-specific modules of treatment satisfaction and QOL	The basal-bolus insulin regimen showed better outcomes in terms of treatment satisfaction and quality of life scores compared to premixed insulin regimens	[203]
	Premixed vs basal bolus	6 months observational prospective study	EQ-5D-3L	Basal-bolus regimen showed the most significant potential to increase HRQOL in comparison to other regimens	[204]
	Glargine + glulisine (BB) vs aspartmix (PM)	BB vs PM after 24 wk of treatment	DTSQ; ITSQ; ADDQOL; EQ-5D	The basal-bolus group showed significantly higher overall satisfaction with treatment, satisfaction with insulin, perceived frequency of hyperglycemia, and overall present quality of life	[137]
	Glargine + glulisine (BB) vs aspartmix (PM)	Baseline vs 60 wk follow up	PAIS-SR; EQ-5D; HFS; DQOL	The basal-bolus regimen showed superior outcomes compared to the premixed group in terms of QOL. The basal-bolus group experienced significant improvements in psychological adjustment to illness and less fear of hypoglycemia. The premixed group reported significant increases in hypoglycemic worry and a significant decline in general health related QOL	[205]
	Glargine + lispro (BB) vs lispromix (PM)	Baseline vs 24 wk follow up	DTSQ; EWITQ	No significant difference between the two groups in term of DTSQ and EWITQ scores except that premixed group showed significantly higher perceived frequency of hypoglycemia than basal-bolus group	[138]
Favor Premixed therapy	Glargine or NPH based BB regimen vs aspartmix (PM)	24 wk prospective study after switching to AspartMix	EQ-5D	Switching to AspartMix showed significant improvement in HRQOL	[206]
	Glargine + glulisine (BB) vs aspartmix (PM)	26 months randomized trial	EQ-5D; DQOL; WPAI	No significant difference of different scales for three questionnaires between two groups except for work missed for health which is significantly lower in BB group	[128]
	NPH + lispro (BB) vs lispromix (PM)	12 wk randomized comparative trial	ITR-QOL	The premixed group exhibited significantly higher scores in the total score and daily activities subscale score of ITR-QOL compared to the basal-bolus group	[207]
Undetectable difference	Glargine + glulisine (BB) vs lispromix or aspartmix (PM)	Patients switched from PM to BB with follow up for 16 wk	DTSQ	No significant difference in treatment satisfaction between two groups	[139]
	Detemir + aspart (BB) vs aspartmix (PM)	Baseline vs 50 wk of treatment	SF-36; DiabMedSat; DPM; TRIM-D	No statistically significant differences between premixed and basal-bolus group in term of patients’ satisfaction, productivity and quality of life	[130]
	Premixed vs basal bolus	Baseline vs 6 months Switching to basal bolus regimen	DQOL	No significant difference in satisfaction, impact of diabetes, social concern and concern related to diabetes after initiation of basal-bolus regimen	[101]
	Glargine + lispro (BB) vs lispromix (PM)	48 wk open label randomized study	EQ-5D; DHP-18	No significant difference of different scales for two questionnaires between two groups	[208]
	Glargine + lispro (BB) vs lispromix (PM)	Baseline vs 24 wk follow up	ITSQ; PAM-D21	No significant difference between the two groups in terms of ITSQ domain and total scores, and PAM-D21 questionnaires domain scores	[132]
	Glargine + lispro (BB) vs lispromix (PM)	Baseline vs 48 wk follow up	EQ-5D; DTSQ	No significant difference between the two groups	[140]
	Glargine + glulisine (BB) vs aspartmix (PM)	Baseline vs 24 wk follow up	DTSQ	No significant difference between the two groups in term of treatment satisfaction	[141]

ADDQOL: Audit of diabetes-dependent quality of life; BB: Basal-bolus; Basal-bolus: Includes both basal plus and full basal-bolus regimens; DHP-18: Diabetes health profile; DiabMedSat: Diabetes medication satisfaction; DPM: Diabetes productivity measure; DQOL: Diabetes quality of life questionnaire; DTSQ: Diabetes treatment satisfaction questionnaire; EQ-5D: Euro quality of life five-dimension; EQ-5D-3L: Euro quality of life -5-dimension 3-level; EWITQ: Experience with insulin therapy questionnaire; HFS: Hypoglycemia fear survey; HRQOL: Health-related quality of life; ITRQOL: Insulin therapy–related quality of life; ITSQ: Insulin treatment satisfaction questionnaire; NPH: Neutral protamine hagedorn; PAIS-SR: Psychosocial adjustment to illness state-self report; PAM-D21: Patients perceptions about medications for diabetes; PM: Premixed; PROMs: Patient-reported outcome measures; QOL: Quality of life; SF-36: Short-form 36 health survey; TRIM-D: Treatment-related impact measure-diabetes; WPAI: Work productivity and activity impairment.