Table 1.

Summary of randomized controlled trials comparing self‐management versus physician‐led management of titration

	TAKE CONTROL52	AT.LANTUS54	ATLAS53	INNOVATE55	AUTOMATIX56
Study length, weeks	24	24	24	12	16
Location	10 European countries	Europe, South America, Asia, Africa/Middle East	Asia	Canada	Germany/UK
Population	Insulin‐naïve and previously treated, age ≥18 years, HbA1c ≥7.0% and ≤10.0% (prior BI) or ≥7.5% and ≤11.0% (BI‐naïve)	Insulin‐naïve and previously treated, age ≥18 years, BMI <40 kg/m2, HbA1c >7.0% and <12.0%	Insulin‐naïve, age 40–75 years, HbA1c ≥7.0% and ≤11.0%	Insulin‐naïve and previously treated, age ≥18 and ≤75 years, BMI ≤45 kg/m2, HbA1c >7.0%	Insulin‐naïve and previously treated, age ≥18 years, HbA1c ≥7.5% and ≤11.0%
Type of titration support	Paper‐based titration algorithm	Paper‐based titration algorithm	Paper‐based titration algorithm	Self‐titration web tool (LTHome)	Self‐titration device (MyStar DoseCoach)
Study drug	Gla‐300	Gla‐100	Gla‐100	Gla‐100	Gla‐300
Key results	Significantly greater HbA1c reductions with self‐ vs. physician‐managed titration and a higher proportion of people achieving HbA1c of <7.0%. Similar incidence of hypoglycaemia (all categories and BG thresholds reported)a in both groups. Slightly greater increase in insulin dose with self‐ vs. physician‐managed titration.	Significantly greater HbA1c reductions with self‐ vs. physician‐managed titration and a higher proportion of people achieving HbA1c of <7.0%. Significantly greater incidence of any hypoglycaemia and symptomatic (<2.8 mmol/L [<50 mg/dL]) hypoglycaemia in the self‐ vs. physician‐managed titration group, but similar incidence of nocturnal hypoglycaemia (occurring during sleep with BG of <2.8 mmol/L [<50 mg/dL]).	Significantly greater HbA1c reductions with self‐ vs. physician‐managed titration and a numerically higher proportion of patients achieving HbA1c of <7.0% without severe hypoglycaemia. Similar incidence of severe hypoglycaemia, but significantly greater incidence of symptomatic (clinical symptoms of hypoglycaemia regardless of BG measurement) hypoglycaemia and nocturnal hypoglycaemia (occurring during sleep with BG of <2.8 mmol/L [<50 mg/dL]) with self‐ vs. physician‐managed titration. Significantly greater increase in insulin dose with self‐ vs. physician‐managed titration.	Similar HbA1c reductions observed between groups and a greater proportion of patients achieving HbA1c of ≤7.0% in the self‐ vs. physician‐managed titration group. Lower achievement of the composite primary outcome‡ in the self‐ vs. physician‐managed titration arm. Incidence of hypoglycaemia (all categories reported)§ was similar in both groups.	Similar HbA1c reductions observed between groups. Numerically greater achievement of fasting SMPG target without severe hypoglycaemia with self‐ vs. physician‐managed titration (not significant). Slightly lower incidence of any hypoglycaemia and confirmed (≤3.9 mmol/L [≤70 mg/dL]) or severe hypoglycaemia, occurring either at night (00:00–05:59 hours) or any time of day (24 hours) with self (device)‐ vs. physician (routine)‐managed titration. Greater dose increases with self‐ vs. physician‐managed titration.

Abbreviations: BG, blood glucose; BI, basal insulin; BMI, body mass index; FPG, fasting plasma glucose; SMPG, self‐measured plasma glucose.

^aAny hypoglycaemia, confirmed or severe at BG thresholds of ≤3.9 mmol/L (≤70 mg/dL) or <3.0 mmol/L (<54 mg/dL) and symptomatic, with all categories reported at any time of day (24 hours) or at night (00:00–05:59 hours); ^‡primary composite outcome: (i) at least four out of seven FPG values within a 10‐day period in the target range (5.0–7.2 mmol/L [90–130 mg/dL]); (ii) mean FPG for three consecutive prior FPG values within a 10‐day period in the target range; (iii) no severe hypoglycaemia during the 7‐10‐day period; ^§overall, nocturnal, daytime, symptomatic or asymptomatic hypoglycaemia, time intervals and BG thresholds were not specified.