TABLE 1.

Characteristics and findings of included studies

Authors (year)	Reference	Design	Country	Sample N (baseline)	Study intervention	Study quality (α q)	Quality of life assessment		Impact of self‐treated symptomatic hypoglycaemia
							Measure	Outcome	Direction a	Sig.
Ali et al. (2012)	35	RCT	US	2053	Intensive versus standard glucose control	0.58	SF‐36	General health
								Physical health		NS
								Mental health		NS
Briggs et al. (2017)	20	RCT	Worldwide	16,492	Saxagliptin versus placebo	0.77	EQ‐5D	General health	b	<0.05
de Sonnaville et al. (1998)	36	Cohort	Netherlands	237	Insulin versus oral medication	1.00	POMS	Negative mood	c	NS
Genovese et al. (2013)	21	Cohort	Italy	1046	Vildagliptin + metformin	0.90	WPAI	Work/school impairment
								Activity impairment		0.001
Goddijn et al. (1999)	22	Cohort	Netherlands	99	Insulin versus oral medication	1.00	RAND‐36	General health
								Mental health		NR
Haluzik et al. (2018)	23	Cohort	Eastern Europe	6369	None	0.93	Targeted question	Work impairment		NA
Jódar et al. (2020)	24	RCT	Worldwide	3297	Semaglutide versus placebo	0.77	SF‐36	General health
								Physical health		<0.01
								Mental health		0.08
Malanda et al. (2011)	25	Cohort	UK	453	G‐Meter versus standard monitoring	1.00	EQ‐5D	General health		0.23
							W‐BQ12	Emotional well‐being		0.82
								Positive mood		0.47
								Negative mood		0.92
								Energy level		0.46
							IPQ‐R	Illness perceptions
								Illness control		NS
								Emotional distress		0.24
Menard et al. (2007)	26	RCT	Canada	72	Intensive versus standard care	0.88	DQOL	DQOL		NS
Mitchell et al. (2013)	27	Cohort	UK	1329	None	0.85	HFS‐II	Fear of hypoglycaemia	d	<0.001
Nauck et al. (2019)	28	RCT	Worldwide	3014	Liraglutide versus placebo	0.85	EQ‐5D	General health	b	<0.001
							EQ‐VAS	General health	b	0.98
Nicolucci et al. (2011)	29	RCT	Italy	238	Telephone versus standard care	0.58	W‐BQ22	Emotional well‐being		0.002
								Positive mood		NS
								Depressive symptoms		NS
								Anxiety symptoms		0.007
								Energy level		0.003
							SF‐36	General health
								Physical health		NS
								Mental health		0.004
Pathan et al. (2018)	38	Cohort	Southeast Asia	2594	None	0.93	Targeted question	Work impairment		NA
Peyrot et al. (2008)	30	RCT	US	211	Pramlintide versus placebo	0.85	DDS	Diabetes distress		NS
Pichayapinyo et al. (2018)	31	Cohort	Thailand	35	Telephone assistance	0.85	DDS	Diabetes distress		NS
							SEDS	Diabetes self‐efficacy		NS
							PHQ‐8	Depressive symptoms		NS
							SSQ	Social support		NS
							PROMIS	General health
								Sleep disturbance		NS
Polonsky et al. (2018)	39	Cohort	US	424	None	0.90	WHO‐5	Emotional well‐being		NS
							GAD	Anxiety symptoms		<0.01
							PHQ‐8	Depressive symptoms		NS
							DDS	Diabetes distress		<0.05
							HFS‐II	Fear of hypoglycaemia
								Hypoglycaemia worry		<0.01
Ritter et al. (2016)	37	RCT	US	1674	Efficacy care versus placebo	0.77	DSES	Diabetes self‐efficacy		0.026
Torre et al. (2018)	32	Cohort	Portugal	1303	DPP‐4 versus GLP‐1 vs.SGLT2	0.90	EQ‐5D	General health		NS
							EQ‐VAS	General health		NS
Wieringa et al. (2018)	33	Cohort	Netherlands	911	Insulin glargine	1.00	WHO‐5	Emotional well‐being	c	0.30
							HFS‐II	Fear of hypoglycaemia
								Hypoglycaemia worry	e	<0.001
Yang et al. (2014)	34	Cohort	China	8578	Biphasic insulin aspart 30/70	0.80	EQ‐VAS	General health	b	<0.001

Abbreviations: DDS, Diabetes Distress Scale; DQOL, Diabetes Quality of Life measure; DSES, Diabetes Self‐Efficacy Scale; EQ‐5D, EuroQol 5‐Dimension health status instrument; EQ‐VAS, EuroQol Visual Analogue Scale; GAD, General Anxiety Disorder scale; HFS‐II, Hypoglycaemia Fear Survey version II; IPQ‐R, Illness Perception Questionnaire Revised; NA, not applicable; NR, not reported; NS, not significant (no p‐value reported); PHQ‐8, Patient Health Questionnaire 8‐item; POMS, Profile of Mood States; PROMIS, Patient‐Reported Outcomes Measurement Information System; RAND‐36, RAND Corporation 36‐item health survey; RCT, randomised controlled trial; SEDS, Self‐Efficacy for Diabetes Scale; SF‐36, Medical Outcomes Study Short Form 36‐item health survey; SSQ, Social Support Questionnaire; W‐BQ12 and W‐BQ22, Well‐Being Questionnaire 12‐item and 22‐item; WHO‐5, World Health Organisation 5‐item well‐being index; WPAI, Work Productivity and Activity Impairment.

^a Increases and decreases in outcomes are depicted with upward () and downward arrows (), respectively; associations of unknown direction are depicted with a dash (); black and grey symbols indicate significant and non‐significant or untested effects, respectively.

^b Reflects impact of severe hypoglycaemic events only.

^c Direction and significance of impact was similar for severe hypoglycaemic events.

^d Reflects impact of any hypoglycaemic event.

^e Direction of impact for severe hypoglycaemic events was similar but not significant, p = 0.23