Real-world use of Control-IQ™ technology automated insulin delivery in pregnancy: A case series with qualitative interviews.

BACKGROUND: Most commercially available automated insulin delivery (AID) systems are not approved for pregnancy use. Information regarding use of the Tandem t:slim X2 insulin pump with Control-IQ™ technology in pregnancy is lacking. AIMS: This case series aimed to explore glycaemic and qualitative experiences of four early adopters of Control-IQ technology in pregnancy. METHODS: Participants used Control-IQ technology in pregnancy and postpartum and consented to analysis of glycaemic data and semi-structured interviews. RESULTS: Case 1 began Control-IQ technology at 10 weeks gestation. Her pregnancy glucose time-in-range (3.5-7.8 mmol/L [63-140 mg/dL]) increased from 58.7% to 73.3% by third trimester. Cases 2-4 began using Control-IQ technology 0-2 months preconception. Pregnancy time-in-range glucose increased from 73.4% to 78.7%, 78% to 83.6%, and 46.5% to 71.9% between first and third trimesters, respectively. A mid-pregnancy decline in time-in-range glucose was observed in two of the four participants related to suboptimal pump setting adjustments and delays in sensor and infusion set replacement. No diabetic ketoacidosis or severe hypoglycaemia occurred. All participants reported reduced diabetes management burden and improved sleep with Control-IQ technology use. CONCLUSIONS: Early adopters of Control-IQ technology safely used this system off-label in pregnancy and reported reduced diabetes management burden and improved sleep. The largest glycaemic improvements were observed among those with the lowest pregnancy time-in-range glucose at the beginning of pregnancy. Participants with low pregnancy glucose time-in-range increased their time-in-range with Control-IQ technology use and participants with high pregnancy glucose time-in-range maintained and increased their time-in-range with less diabetes management burden.

Case series of a hybrid closed-loop system used in pregnancies in clinical practice.

BACKGROUND: Hybrid closed-loop (HCL) therapy is rarely studied in pregnancy. We present three cases of women with type 1 diabetes who used the Medtronic 670G HCL system for most or all of gestation. METHODS: The Medtronic 670G system has a manual mode (no automated insulin delivery) and an auto mode (AM, HCL therapy). Women in this case series used AM off-label in gestation. RESULTS: Case 1 started HCL therapy in the second trimester, her sensor glucose time spent <3.9 and >10 mmol/L improved thereafter. Case 1 had average sensor glucose (ASG) levels of 6.4 ± 2.4 mmol/L in the first trimester, 7.0 ± 2.7 mmol/L in the second trimester before HCL use, 7.1 ± 2.1 mmol/L in the second trimester after HCL use, and 6.8 ± 1.9 mmol/L in the third trimester. Case 1 continued AM during operative delivery and post-partum. Cases 2 and 3 used HCL therapy throughout gestation but with inconsistent time in AM. When they increased time in AM their glycaemic indices improved. Case 2 had ASG of 9.5 ± 3.4, 8.6 ± 2.9, and 7.9 ± 2.5 mmol/L in the first through third trimesters, respectively. Case 3 had ASG of 11.1 ± 4.8 and 3.9 to 10 mmol/L in the first and second trimesters, respectively. Case 2 continued HCL therapy post-partum, Case 3 did not. CONCLUSIONS: CareLink® Clinical Software only reports the non-pregnant time in range. Nonetheless, this represents the first report of HCL therapy in pregnancy with a system approved by the Food and Drug Administration in non-pregnant populations.

Clinical Outcomes with MiniMedTM 780G Advanced Hybrid Closed-Loop Therapy in 2- to 6-Year-Old Children with Type 1 Diabetes.

Advanced hybrid closed-loop (AHCL) therapy with the Medtronic MiniMed™ 780G system improves glycemia; however, the clinical outcomes in younger children remain less established. This pilot study aimed to explore the continuous glucose monitoring (CGM) metrics in very young children on AHCL. Children between 2 and 7 years of age and on insulin pump therapy were recruited. A 2-week phase in manual mode was followed by a 6-week AHCL phase. CGM metrics were analyzed to review glycemic outcomes. Out of 11 participants enrolled [mean (standard deviation [SD]) age 5.3 (0.8) years], 10 completed the study. Time in closed loop was 96.7 (3.9)%. In AHCL, participants had a mean (SD) time in range of 72.6 (7.4)% and spent 3.0 (1.74)% and 0.63 (0.46)% in time <70 and <54 mg/dL, respectively. AHCL is a feasible option for management of young children with type 1 diabetes.

Randomized Trial of Assisted Hybrid Closed-Loop Therapy Versus Sensor-Augmented Pump Therapy in Pregnancy.

Objective: Examine gestational safety, glycemic and health outcomes, of a hybrid closed-loop (HCL) system without pregnancy-specific glucose targets. Research Design: This was a pilot feasibility investigator-initiated, two-site, single-blind, randomized controlled trial of sensor-augmented pump therapy (SAPT) versus HCL therapy in type 1 diabetes pregnancies. Participants were enrolled in the first trimester and randomized at 14-18 weeks of gestation and used SAPT or HCL until 4-6 weeks postpartum. We compared continuous glucose monitoring (CGM) metrics, severe hypoglycemia (SH), diabetic ketoacidosis (DKA), adverse skin reactions, and pregnancy outcomes between groups. Results: Baseline characteristics were similar between groups (n = 11 HCL and n = 12 SAPT). There was no SH or DKA episode after randomization. Time spent <54 mg/dL did not differ between groups. Time spent <63 mg/dL decreased in both groups, significantly in the HCL group (3.5% [1.3% standard error] second trimester and 2.8% [1.3%] third trimester vs. 7.9% [1.3%] run-in phase, P < 0.05 for both). Mean sensor glucose was lower with SAPT compared to HCL therapy in the third trimester (119 [4] mg/dL SAPT vs. 132 [4] mg/dL HCL, P < 0.05). Third trimester time-in-range (TIR; 63-140 mg/dL) increased with SAPT (68.2% [3.1%] vs. 64.3% [3.1%] run-in phase, P < 0.05). Gestational health outcomes did not differ between groups. The HCL group used assistive techniques, such as fake carbohydrate boluses and exiting HCL overnight. Conclusions: CGM within group differences were seen for time <63 mg/dL favoring HCL therapy and TIR favoring SAPT (third trimester vs. baseline). Safety and adverse pregnancy outcomes were similar between groups.

Women's and Partners' Experiences with a Closed-Loop Insulin Delivery System to Manage Type 1 Diabetes in the Postpartum Period.

BACKGROUND: Closed-loop insulin delivery has the potential to offer women with type 1 diabetes a break from intense diabetes self-care efforts during postpartum. AIMS: To explore the views and opinions of hybrid closed-loop users and their partners in the first 24 weeks postpartum. METHODS: This qualitative study was embedded in a controlled study of women with type 1 diabetes randomized to (MiniMed™ 670G/770G) closed-loop insulin delivery or sensor augmented pump use 1-11 weeks 6 days postpartum, with all on closed-loop from 12 to 24 weeks postpartum. Semi-structured interviews were conducted with 16 study participants and their partners at 12 and 24 weeks postpartum. Thematic analyses were used to examine participants' and partners' experiences. RESULTS: Participants' positive perceptions of the closed-loop use related to reduced hypoglycemia, in contrast to previous experiences with nonautomated insulin delivery. These were balanced against frustrations with the system allowing blood glucose levels to be above what they desired. Closed-loop use did not influence infant feeding choice. Yet, infant feeding and care impacted participants' diabetes management. Partners expressed uncertainty about the closed-loop taking away control from participants who were highly skilled with diabetes self-management. CONCLUSIONS: Participants reported that the closed-loop resulted in less time spent in hypoglycemia; compared to previously used nonautomated insulin delivery. Yet, participants desired greater understanding into the workings of the closed-loop algorithm. This study provides potential users with realistic expectations about the user experience with the MiniMed™ 670G/770G closed-loop in the postpartum period.

Expert Guidance on Off-Label Use of Hybrid Closed-Loop Therapy in Pregnancies Complicated by Diabetes.

Automated insulin delivery (AID) systems have established benefits in terms of glycemic control, health outcomes, and quality of life and are strongly recommended for people with type 1 diabetes outside of pregnancy. While evidence for use of investigational AID systems during pregnancy is promising, data and guidance are still needed regarding use of commercially available systems during pregnancy. Unfortunately, none of the hybrid closed-loop (HCL) systems that are currently available in the United States have glucose targets that are as aggressive as pregnancy glycemic targets, none have a pregnancy-specific algorithm, and none are approved for use during pregnancy. As such, any use of these systems during pregnancy is considered off-label in the United States and would be "assisted" by provider/user techniques. Despite these limitations, many women conceive while using clinically available HCL systems and may be hesitant to cease use during pregnancy. Achievement of strict pregnancy glycemic targets can be difficult, and it is conceivable that selective off-label use of clinically available HCL systems in some women could lead to improved glycemia. We herein offer expert guidance based on clinical experience and available case reports on how to identify appropriate candidates for HCL therapy in pregnancy, how to counsel pregnant women with diabetes on the potential risks and benefits of HCL therapy during pregnancy, and how to manage commercially available systems off-label throughout gestation in an assisted HCL approach.