. 2023 Oct 5;3:132. doi: 10.1038/s43856-023-00358-x

Table 4.

CGM articles with precision-directed analyses or subpopulations of interest.

Author year (trial/cohort title) location	Analysis type/study design/number of randomized	Primary endpoint (SIG vs. NS)—% dropout multiple test correction performed?	Subgroup analyses—technology superior to standard of care	Subgroup analyses—technology comparable to standard of care
Battelino²² (SWITCH) Europe	Primary Randomized crossover 153	HbA1c 6 months (SIG)—0% Unsure	Age Mean HbA1c difference in ages 6–18 years (n = 72) −0.46% (95% CI: −0.26% to −0.66%; p < 0.001) and in ages 19–70 years (n = 81) −0.41% (95% CI: −0.28% to −0.53%; p < 0.001).
Mauras²⁵ (DirecNet) USA	Primary RCT 137	HbA1c reduction ≥0.5% a6 months (NS)—6% Unsure	Sensor wear Of 28 children who wore the sensor ≥ 6 days/week during month 6, reduction in HbA1c compared with the 41 who did not (HbA1c change −0.3 ± 0.7% vs. 0.0 ± 0.5%, p = 0.01).	Age, sex, race/ethnicity, parent education level, MDI vs. pump, HbA1c, BMI No difference in HbA1c between CGM and SMBG (ages 4–9 years: 33 age 4–5; 43 age 6–7; 61 age 8–9).
Laffel¹⁷ (CITY) USA	Primary RCT 153	Δ HbA1c 6 months (SIG)—7% Yes^a	Age < 19 vs. ≥19 years, HbA1c < 9 vs. ≥9%, MDI vs. pump, sex, race, detectable C-peptide, prior CGM use Entire cohort (ages 14–24 years) had an HbA1c difference of −0.37% (95% CI: −0.66%, to −0.08%; p = 0.01).
VanName³² (SENCE) USA	Extension RCT 143	TIR 6 months (NS)—4% Yes^a	Age In ages 2–7 years reduction in TBR during extension study within groups (CGM + family behavioral intervention: −1.4%, CGM: −2%, SMBG-to-CGM: −2.8%; p < 0.001 for all).	Age In ages 2–7 years, there was no significant increase in TIR (about +3%) or decrease in HbA1c (about −0.1%) during extension study within or between groups.
Raviteja¹⁵ India	Primary RCT 68	Δ HbA1c 3 months (NS)—7% Unsure	HbA1c Children with HbA1c > 7.5% at baseline demonstrated a significant decrease in HbA1c (−1.27% ± 1.46 vs. 0.13% ± 1.76; p = 0.045).	Age, HbA1c In ages 2–10 years there was no significant decrease in HbA1c using CGM or with baseline HbA1c < 7.5%.
Miller³⁵ (WISDM) USA	Extension RCT 203	Δ TBR 6 months (SIG)—2% Yes^a	Age, MDI vs. pump, daytime vs. nighttime Seniors (aged 60–87 years) on CGM had reduced TBR (−3.4%, −3.1%) and HbA1c (+8%, +4%) and increased TIR (−0.2%, −0.2%); p ≤ 0.01 for all.
vanBeers¹⁴ (IN CONTROL) Netherlands	Primary Randomized crossover 52	TIR 8 months (SIG)—12% Unsure	IAH, MDI vs. pump, carbohydrate counting vs. not Adults (aged 18–75 years) with IAH had improved TIR (+9.6% [95% CI: 8.0–11.2%]; p < 0.0001) and fewer SH events (14 vs. 34, p = 0.033)
Beck²¹ (DIaMonD) USA	Primary RCT 158	Δ HbA1c 6 months (SIG)–2% Yes	Age, HbA1c, TBR, SMBG frequency, education level, IAH, MDI only, diabetes numeracy, and hypoglycemia fear scores HbA1c improvement in adults, ages 26–73 years on MDI (–0.6% [95% CI: −0.8% to −0.3%]; p < 0.001).
Heinemann¹⁸ (HypoDE) Germany	Primary RCT 149	# hypoglycemic events 6 months (SIG)—5% Unsure	IAH, MDI only Hypoglycemia events decreased (IRR 0.28 [95% CI: 0.20–0.39]; p < 0.0001) in ages ≥ 18 years with IAH on MDI.
Oskarsson²⁹ (IMPACT) Europe	Secondary RCT 163	Δ TBR at 6 months (SIG)—1% No	MDI only, HbA1c TBR improved in adults, ages ≥ 18 years, on MDI with baseline HbA1c ≤ 7.5% (–1.65% [95% CI: –2.21 to –1.09%]; p < 0.0001).

Author year (trial/cohort title) location

Analysis type/study design/number of randomized

Primary endpoint (SIG vs. NS)—% dropout multiple test correction performed?

Subgroup analyses—technology superior to standard of care

Subgroup analyses—technology comparable to standard of care

Battelino²² (SWITCH)

Europe

Primary

Randomized crossover

153

HbA1c 6 months (SIG)—0%

Unsure

Age

Mean HbA1c difference in ages 6–18 years (n = 72) −0.46% (95% CI: −0.26% to −0.66%; p < 0.001) and in ages 19–70 years (n = 81) −0.41% (95% CI: −0.28% to −0.53%; p < 0.001).

Mauras²⁵ (DirecNet)

USA

Primary

RCT

137

HbA1c reduction ≥0.5% a6 months (NS)—6%

Unsure

Sensor wear

Of 28 children who wore the sensor ≥ 6 days/week during month 6, reduction in HbA1c compared with the 41 who did not (HbA1c change −0.3 ± 0.7% vs. 0.0 ± 0.5%, p = 0.01).

Age, sex, race/ethnicity, parent education level, MDI vs. pump, HbA1c, BMI

No difference in HbA1c between CGM and SMBG (ages 4–9 years: 33 age 4–5; 43 age 6–7; 61 age 8–9).

Laffel¹⁷ (CITY)

USA

Primary

RCT

153

Δ HbA1c 6 months (SIG)—7%

Yes^a

Age < 19 vs. ≥19 years, HbA1c < 9 vs. ≥9%, MDI vs. pump, sex, race, detectable C-peptide, prior CGM use

Entire cohort (ages 14–24 years) had an HbA1c difference of −0.37% (95% CI: −0.66%, to −0.08%; p = 0.01).

VanName³² (SENCE)

USA

Extension

RCT

143

TIR 6 months (NS)—4%

Yes^a

Age

In ages 2–7 years reduction in TBR during extension study within groups (CGM + family behavioral intervention: −1.4%, CGM: −2%, SMBG-to-CGM: −2.8%; p < 0.001 for all).

Age

In ages 2–7 years, there was no significant increase in TIR (about +3%) or decrease in HbA1c (about −0.1%) during extension study within or between groups.

Raviteja¹⁵

India

Primary

RCT

Δ HbA1c 3 months (NS)—7%

Unsure

HbA1c

Children with HbA1c > 7.5% at baseline demonstrated a significant decrease in HbA1c (−1.27% ± 1.46 vs. 0.13% ± 1.76; p = 0.045).

Age, HbA1c

In ages 2–10 years there was no significant decrease in HbA1c using CGM or with baseline HbA1c < 7.5%.

Miller³⁵ (WISDM)

USA

Extension

RCT

203

Δ TBR 6 months (SIG)—2%

Yes^a

Age, MDI vs. pump, daytime vs. nighttime

Seniors (aged 60–87 years) on CGM had reduced TBR (−3.4%, −3.1%) and HbA1c (+8%, +4%) and increased TIR (−0.2%, −0.2%); p ≤ 0.01 for all.

vanBeers¹⁴ (IN CONTROL)

Netherlands

Primary

Randomized crossover

TIR 8 months (SIG)—12%

Unsure

IAH, MDI vs. pump, carbohydrate counting vs. not

Adults (aged 18–75 years) with IAH had improved TIR (+9.6% [95% CI: 8.0–11.2%]; p < 0.0001) and fewer SH events (14 vs. 34, p = 0.033)

Beck²¹ (DIaMonD)

USA

Primary

RCT

158

Δ HbA1c 6 months (SIG)–2%

Yes

Age, HbA1c, TBR, SMBG frequency, education level, IAH, MDI only, diabetes numeracy, and hypoglycemia fear scores

HbA1c improvement in adults, ages 26–73 years on MDI (–0.6% [95% CI: −0.8% to −0.3%]; p < 0.001).

Heinemann¹⁸ (HypoDE)

Germany

Primary

RCT

149

# hypoglycemic events 6 months (SIG)—5%

Unsure

IAH, MDI only

Hypoglycemia events decreased (IRR 0.28 [95% CI: 0.20–0.39]; p < 0.0001) in ages ≥ 18 years with IAH on MDI.

Oskarsson²⁹ (IMPACT)

Europe

Secondary

RCT

163

Δ TBR at 6 months (SIG)—1%

MDI only, HbA1c

TBR improved in adults, ages ≥ 18 years, on MDI with baseline HbA1c ≤ 7.5% (–1.65% [95% CI: –2.21 to –1.09%]; p < 0.0001).

^aFDR adjustment using Benjamini Hochberg procedure.