Aims
We aimed to conduct a systematic review and meta‐analysis of randomised controlled clinical trials (RCTs) assessing separately and together the effect of the three distinct categories of ...continuous glucose monitoring (CGM) systems (adjunctive, non‐adjunctive and intermittently‐scanned CGM isCGM), compared with traditional capillary glucose monitoring, on HbA1c and CGM metrics.
Methods
PubMed, Web of Science, Scopus and Cochrane Central register of clinical trials were searched. Inclusion criteria were as follows: randomised controlled trials; participants with type 1 diabetes of any age and insulin regimen; investigating CGM and isCGM compared with traditional capillary glucose monitoring; and reporting glycaemic outcomes of HbA1c and/or time‐in‐range (TIR). Glycaemic outcomes were extracted post‐intervention and expressed as mean differences and 95%CIs between treatment and comparator groups. Results were pooled using a random‐effects meta‐analysis. Risk of bias was assessed using the Cochrane Rob2 tool.
Results
This systematic review was conducted between January and April 2021; it included 22 RCTs (15 adjunctive, 5 non‐adjunctive, and 2 isCGM)). The overall analysis of the pooled three categories showed a statistically significant absolute improvement in HbA1c percentage points (mean difference (95% CI): −0.22% −0.31 to −0.14, I2 = 79%) for intervention compared with comparator and was strongest for adjunctive CGM (−0.26% −0.36, −0.16). Overall TIR (absolute change) increased by 5.4% (3.5 to 7.2), I2 = 71% for CGM intervention compared with comparator and was strongest with non‐adjunctive CGM (6.0% 2.3, 9.7).
Conclusions
For individuals with T1D, use of CGM was beneficial for impacting glycaemic outcomes including HbA1c, TIR and time‐below‐range (TBR). Glycaemic improvement appeared greater for TIR for newer non‐adjunctive CGM technology.
Open-Source Automated Insulin Delivery in Type 1 Diabetes Burnside, Mercedes J; Lewis, Dana M; Crocket, Hamish R ...
New England journal of medicine/The New England journal of medicine,
09/2022, Letnik:
387, Številka:
10
Journal Article
Recenzirano
Odprti dostop
Open-source automated insulin delivery (AID) systems are used by many patients with type 1 diabetes. Data are needed on the efficacy and safety of an open-source AID system.
In this multicenter, ...open-label, randomized, controlled trial, we assigned patients with type 1 diabetes in a 1:1 ratio to use an open-source AID system or a sensor-augmented insulin pump (control). The patients included both children (defined as 7 to 15 years of age) and adults (defined as 16 to 70 years of age). The AID system was a modified version of AndroidAPS 2.8 (with a standard OpenAPS 0.7.0 algorithm) paired with a preproduction DANA-i insulin pump and Dexcom G6 CGM, which has an Android smartphone application as the user interface. The primary outcome was the percentage of time in the target glucose range of 70 to 180 mg per deciliter (3.9 to 10.0 mmol per liter) between days 155 and 168 (the final 2 weeks of the trial).
A total of 97 patients (48 children and 49 adults) underwent randomization (44 to open-source AID and 53 to the control group). At 24 weeks, the mean (±SD) time in the target range increased from 61.2±12.3% to 71.2±12.1% in the AID group and decreased from 57.7±14.3% to 54.5±16.0% in the control group (adjusted difference, 14 percentage points; 95% confidence interval, 9.2 to 18.8; P<0.001), with no treatment effect according to age (P = 0.56). Patients in the AID group spent 3 hours 21 minutes more in the target range per day than those in the control group. No severe hypoglycemia or diabetic ketoacidosis occurred in either group. Two patients in the AID group withdrew from the trial owing to connectivity issues.
In children and adults with type 1 diabetes, the use of an open-source AID system resulted in a significantly higher percentage of time in the target glucose range than the use of a sensor-augmented insulin pump at 24 weeks. (Supported by the Health Research Council of New Zealand; Australian New Zealand Clinical Trials Registry number, ACTRN12620000034932.).
Aims
To investigate the experiences of parents caring for young children with type 1 diabetes type 1 diabetes using a do‐it‐yourself continuous glucose monitor (DIYrtCGM) in a supported setting.
...Methods
Exit interviews were conducted with parents from 11 families at the end of the MiaoMiao study: a randomised cross‐over trial focusing on parental fear of hypoglycaemia. Technical support was provided to participants while using DIYrtCGM during the trial. A convenience sampling approach was used to recruit parents. An in‐depth, semi‐structured interview approach was used. Thematic analysis was used to identify key themes and subthemes.
Results
Parents identified that remote monitoring enabled proactive management and that overall alarms/glucose alerts were useful. Some parents reported reductions in anxiety, increased independence for their child, and improvements in the child–parent relationship. However, parents also reported regular signal loss with DIYrtCGM, along with complicated apps and challenges troubleshooting technical problems. Despite this, nine of the 11 families continued to use the system after the end of the trial.
Conclusions
Do‐it‐yourself continuous glucose monitoring (CGM) was on balance beneficial for the parents interviewed. However, while access to CGM shifted the burden of care experienced by parents, burden did not significantly reduce for all parents, as the improved glycaemic control that they achieved was accompanied with the responsibility for continually monitoring their child’s data. Supported use of do‐it‐yourself CGM may be an achievable, cost‐effective option for parents caring for children with type 1 diabetes in countries without funded access to CGM.
Background
Automated insulin delivery aims to lower treatment burden and improve quality of life as well as glycemic outcomes.
Methods
We present sub-study data from a dual-center, randomized, ...open-label, two-sequence crossover study in automated insulin delivery naïve users, comparing Medtronic MiniMed® Advanced Hybrid Closed-Loop (AHCL) to Sensor Augmented Pump therapy with Predictive Low Glucose Management (SAP + PLGM). At the end of each 4-week intervention, impacts on quality of life, sleep and treatment satisfaction were compared using seven age-appropriate validated questionnaires given to patients or caregivers.
Results
59/60 people completed the study (mean age 23.3 ± 14.4yrs). Statistically significant differences favoring AHCL were demonstrated in several scales (data shown as mean ± SE). In adults (≥ 18yrs), technology satisfaction favored AHCL over PLGM as shown by a higher score in the DTSQs during AHCL (
n
= 28) vs SAP + PLGM (
n
= 29) (30.9 ± 0.7 vs 27.9 ± 0.7,
p
= 0.004) and DTSQc AHCL (
n
= 29) vs SAP + PLGM (
n
= 30) (11.7 ± 0.9 vs 9.2 ± 0.8,
p
= 0.032). Adolescents (aged 13–17yrs) also showed a higher DTSQc score during AHCL (
n
= 16) versus SAP + PLGM (
n
= 15) (14.8 ± 0.7 vs 12.1 ± 0.8,
p
= 0.024). The DTQ “change” score (
n
= 59) favored AHCL over SAP + PLGM (3.5 ± 0.0 vs 3.3 ± 0.0,
p
< 0.001). PSQI was completed in those > 16 years (
n
= 36) and demonstrated improved sleep quality during AHCL vs SAP + PLGM (4.8 ± 0.3 vs 5.7 ± 0.3,
p
= 0.048) with a total score > 5 indicating poor quality sleep.
Conclusion
These data suggest that AHCL compared to SAP + PLGM mode has the potential to increase treatment satisfaction and improve subjective sleep quality in adolescents and adults with T1D.
Background
Continuous glucose monitoring (CGM) decreases fear of hypoglycemia (FOH) and improves glycemic control among those affected by type 1 diabetes (T1D). No studies to date have examined the ...impact of using do‐it‐yourself real‐time continuous glucose monitoring (DIY RT‐CGM) on psychological and glycemic outcomes.
Methods
Child–parent dyads were recruited for a multicentre randomized crossover trial. Children with T1D were current intermittently scanned CGM (isCGM) users and aged 2–13 years. Families received either 6 weeks of DIY RT‐CGM with parental remote monitoring (intervention) or 6 weeks of isCGM plus usual diabetes care (control), followed by a 4‐week washout period, then crossed over. The primary outcome was parental FOH. Secondary outcomes were glycemic control using traditional CGM metrics, as well as a range of other psychosocial measures.
Findings
Fifty five child–parent dyads were recruited. The child mean age was 9.1 ± 2.8 years. Although, there was no effect on parental FOH, −0.1 (95%CI: −0.3, 0.1, p = 0.4), time‐in‐range (TIR) (%3.9‐10 mmol/L) was significantly higher with DIY RT‐CGM over isCGM (54.3% ± 13.7 vs. 48.1% ± 13.6), mean difference, 5.7% (95%CI 1.8, 9.6, p <0.004). There was no difference for time spent in hypoglycemia. Parent diabetes treatment satisfaction was significantly higher following DIY RT‐CGM compared to isCGM, mean difference 5.3 (95%CI: 2.3, 8.2, p <0.001).
Conclusion
The use of DIY RT‐CGM versus isCGM did not improve parental FOH; however, TIR and parental satisfaction with diabetes treatment were significantly improved. This suggests in the short term, DIY RT‐CGM appears safe and may offer families some clinically important advantages over isCGM.
Abstract
Purpose
To explore the lived experiences of alcohol consumption among young adults with type 1 diabetes.
Methods
Fourteen semi-structured interviews were conducted amongst young adults aged ...between 18 and 25 years, inclusive, with type 1 diabetes and experience consuming alcohol. Interviews were transcribed verbatim and analysed to identify common themes regarding their experiences.
Results
The interviews confirmed that young adults with type 1 diabetes engage in social, and occasionally excessive, drinking behaviour. Furthermore, the interviews revealed four key themes: (i) Several sources contribute to a widely inconsistent understanding of the impact and management of alcohol consumption; (ii) Perceived inconvenience of maintaining healthy glycaemic control whilst drinking socially; (iii) Engagement in proactive strategies for harm reduction occurred when convenient; and (iv) Impact of modern diabetes technology in overcoming previous burdens and promoting glycaemic safety.
Conclusion
Young adults with type 1 diabetes continue to need anticipatory education surrounding safe alcohol consumption and behaviours, as well as ongoing support and encouragement to ensure engagement with traditional self-management tasks. Significant alcohol-diabetes related safety issues, particularly hypoglycaemia do occur, and were captured within this small sample and study. Diabetes technology has an important complementary role along with education and tailored support strategies to support health and safe glucose control during alcohol consumption.
Aims
To describe the impact of a 12‐month intervention using intermittently scanned continuous glucose monitoring (isCGM) on glycaemic control and glucose test frequency in adolescents and young ...adults with type 1 diabetes (T1D) and high‐risk glycaemic control (HbA1c ≥75 mmol/mol ≥9.0%).
Methods
In total, 64 young people (aged 13–20 years, 16.6 ± 2.1 years; 48% female; 41% Māori or Pacific ethnicity; mean diabetes duration 7.5 ± 3.8 years) with T1D were enrolled in a 6‐month, randomized, parallel‐group study comparing glycaemic outcomes from the isCGM intervention (n = 33) to self monitoring blood glucose (SMBG) controls (n = 31). In this 6‐month extension phase, both groups received isCGM; HbA1c, glucose time‐in‐range (TIR), and combined glucose test frequency were assessed at 9 and 12 months.
Results
At 12 months, the mean difference in HbA1c from baseline was −4 mmol/mol −0.4% (95% confidence interval, CI: −8, 1 mmol/mol −0.8, 0.1%; p = 0.14) in the isCGM intervention group, and −7 mmol/mol −0.7% (95% CI: −16, 1 mmol/mol −1.5, 0.1%; p = 0.08) in the SMBG control group. No participants achieved ≥70% glucose TIR (3.9–10.0 mmol/L). The isCGM intervention group mean rate of daily glucose testing was highest at 9 months, 2.4 times baseline rates (p < 0.001), then returned to baseline by 12 months (incidence rate ratio = 1.4; 95% CI: 0.9, 2.1; p = 0.091).
Conclusions
The use of isCGM in young people with high‐risk T1D resulted in transient improvements in HbA1c and glucose monitoring over a 9‐month time frame; however, benefits were not sustained to 12 months.
Technology use in type 1 diabetes (T1D) is impacted by socioeconomic status (SES). This analysis explored relationships between SES, glycemic outcomes, and technology use.
A cross-sectional analysis ...of HbA1c data from 2,822 Australian youth with T1D was undertaken. Residential postcodes were used to assign SES based on the Index of Relative Socio-Economic Disadvantage (IRSD). Linear regression models were used to evaluate associations among IRSD quintile, HbA1c, and management regimen.
Insulin pump therapy, continuous glucose monitoring, and their concurrent use were associated with lower mean HbA1c across all IRSD quintiles (P < 0.001). There was no interaction between technology use and IRSD quintile on HbA1c (P = 0.624), reflecting a similar association of lower HbA1c with technology use across all IRSD quintiles.
Technology use was associated with lower HbA1c across all socioeconomic backgrounds. Socioeconomic disadvantage does not preclude glycemic benefits of diabetes technologies, highlighting the need to remove barriers to technology access.
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