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Review
. 2025 Aug 12;17(1):325.
doi: 10.1186/s13098-025-01906-2.

Daytime and nighttime glycemic control with control-IQ technology vs. standard therapy in type 1 diabetes: a systematic review and meta-analysis with trial sequential analysis and GRADE assessment

Rahma Mogahed Rateb  1 , Ammar Salah  2 , Ahmed Kertam  3 , Youssef Adel Youssef Ashmawi  4 , Nourhan Hatem Mahmoud  5 , Eslam Afifi  6 , Ahmed Bayoumi  4 , Salma Allam  7 , Mohamed Saad Rakab  8
Affiliations
Review

Daytime and nighttime glycemic control with control-IQ technology vs. standard therapy in type 1 diabetes: a systematic review and meta-analysis with trial sequential analysis and GRADE assessment

Rahma Mogahed Rateb et al. Diabetol Metab Syndr. .

Abstract

Background: Automated insulin delivery showed better results than standard insulin therapy, such as MDI. Therefore, we aimed to discuss the efficacy of Control IQ hybrid closed loop (HCL) during the daytime and nighttime for the type 1 diabetic population without restriction in age group or disease severity.

Methods: We searched PubMed, Scopus, Cochrane Library, Web of Science, and related article citations. We analyzed the time in range (TIR), time below range (TBR), time above range (TAR), HBA1c, and serious adverse events (AEs) to ensure safety and efficacy. We used a random effects model when heterogeneity was present; otherwise, we used a fixed effects model. Data was presented as mean difference and 95% confidence intervals.

Results: We selected seven randomized controlled trials (RCTs) out of 1339 articles for the analysis. After analysis of pooled studies data, Control IQ showed improvement in TIR 70–180 mg/dl 24 h data (MD 11.75%, CI 95% (9.54 to 13.97), p = 0.000001) with a similar effect observed in daytime and nighttime. Significant reduction in HbA1c (MD -0.38%, CI 95% (-0.55 to -0.22), p = 0.00001) and 24-hour coefficient variation (CV) measurement (MD -1.42%, CI 95% (-2.22 to -0.61), p = 0.0006) in the Control IQ group compared to the standard therapy group. However, daytime TBR < 70 mg/dl did not show significant improvement (MD -0.22%, CI 95% (-0.50 to 0.06), p = 0.12). Regarding safety, Control IQ reduction in DKA was insignificant (OR 1.48 (CI 95%: 0.23–9.55), p = 0.68).

Conclusion: Control IQ showed better blood glucose control than standard insulin therapy, with some considerations regarding daytime glycemic control that need further assessment.

Supplementary Information: The online version contains supplementary material available at 10.1186/s13098-025-01906-2.

Keywords: Artificial pancreas; Closed loop; Control IQ; Type 1 diabetes.

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Conflict of interest statement

Declarations. Ethics and consent to participate declarations: Not applicable. Competing interests: The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
PRISMA flow diagram
Fig. 2
Fig. 2
(a) Time in range (TIR) 70-180 mg/dl, (b) Nighttime TIR 70-180 mg/dl, (c) Daytime TIR 70-180 mg/dl
Fig. 3
Fig. 3
(a) Time in range (TIR) 70-140 mg/dl, (b) Nighttime TIR 70-140 mg/dl, (c) Daytime TIR 70-140 mg/dl
Fig. 4
Fig. 4
(a) Time below range (TBR) 70 mg/dl, (b) Nighttime TBR 70 mg/dl, (c) Daytime TBR 70 mg/dl
Fig. 5
Fig. 5
TIR 70–140 mg/dl trial sequential analysis, the required information size (RIS) to detect or reject the mean difference of 8.52 (C.I: 4.23 to 12.82) found in the Der Simonian-Laird (DL) model has been 311 participants using the Diversity found of 78%, with a double sided α of 0.05 and a β of 0.20 (power of 80.0%). We used a more conservative RIS of 480 to avoid a software limitation of graph report formation. The cumulative Z- curve (blue full line) passed both Superiority boundary and RIS sample line which suggest that the cumulative evidence is sufficient to conclude that Control IQ is superior to control group with the existing evidence
See this image and copyright information in PMC

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