Closed-Loop Insulin Delivery Versus Sensor-Augmented Pump Therapy in Older Adults With Type 1 Diabetes (ORACL): A Randomized, Crossover Trial

Abstract

OBJECTIVE To assess the efficacy and safety of closed-loop insulin delivery compared with sensor-augmented pump therapy among older adults with type 1 diabetes. RESEARCH DESIGN AND METHODS This open-label, randomized (1:1), crossover trial compared 4 months of closed-loop versus sensor-augmented pump therapy. Eligible adults were aged ≥60 years, with type 1 diabetes (duration ≥10 years), using an insulin pump. The primary outcome was continuous glucose monitoring (CGM) time in range (TIR; 3.9–10.0 mmol/L). RESULTS There were 30 participants (mean age 67 [SD 5] years), with median type 1 diabetes duration of 38 years (interquartile range [IQR] 20–47), randomized (n = 15 to each sequence); all completed the trial. The mean TIR was 75.2% (SD 6.3) during the closed-loop stage and 69.0% (9.1) during the sensor-augmented pump stage (difference of 6.2 percentage points [95% CI 4.4 to 8.0]; P < 0.0001). All prespecified CGM metrics favored closed loop over the sensor-augmented pump; benefits were greatest overnight. Closed loop reduced CGM time <3.9 mmol/L during 24 h/day by 0.5 percentage points (95% CI 0.3 to 1.1; P = 0.0005) and overnight by 0.8 percentage points (0.4 to 1.1; P < 0.0001) compared with sensor-augmented pump. There was no significant difference in HbA1c between closed-loop versus sensor-augmented pump stages (7.3% [IQR, 7.1–7.5] (56 mmol/mol [54–59]) vs. 7.5% [7.1–7.9] (59 mmol/mol [54–62]), respectively; P = 0.13). Three severe hypoglycemia events occurred during the closed-loop stage and two occurred during the sensor-augmented pump stage; no hypoglycemic events required hospitalization. One episode of diabetic ketoacidosis occurred during the sensor-augmented pump stage; no serious adverse events occurred during the closed-loop stage. CONCLUSION Closed-loop therapy is an effective treatment option for older adults with long-duration type 1 diabetes, and no safety issues were identified. These older adults had higher TIR accompanied by less time below range during closed loop than during sensor-augmented pump therapy. Of particular clinical importance, closed loop reduced the time spent in hypoglycemic range overnight.

Exercise habits and glucose management among older adults with type 1 diabetes using insulin pumps

“…Most closed-loop users found that closed loop benefitted their exercise-related glucose management, in keeping with research demonstrating that older age is not necessarily a barrier to embracing diabetes technology [3,5]. The majority of study participants demonstrated a 'trialand-error'-style approach to exercise-related glucose management, highlighting potential roles for clinicians to actively engage in further education.…”

“…We conducted a cross-sectional survey involving adults aged ≥ 60 years, with T1D for ≥ 10 years and using an insulin pump, at a tertiary hospital in Australia. Participants were recruited from the OldeR Adult Closed Loop (ORACL) trial [ 3 ]. After obtaining consent, data were collected at a single study visit (via telephone or videoconference) and from medical records.…”

Fluidic enabled bioelectronic implants: opportunities and challenges

“…Such devices can use real-time information about biomarkers that can then be incorporated into algorithms that control the timing and quantity of drug delivery. Neurological disorders such as epilepsy and Parkinson's disease as well as other diseases such as diabetes 18–23 have been treated with closed-loop drug delivery. Such devices may control drug release by a variety of means from pressure to electric-field to diffusion.…”

“…drug delivery. Neurological disorders such as epilepsy and Parkinson's disease as well as other diseases such as diabetes [18][19][20][21][22][23] have been treated with closed-loop drug delivery. Such devices may control drug release by a variety of means from pressure to electric-field to diffusion.…”

Practical Guidance on Open Source and Commercial Automated Insulin Delivery Systems: A Guide for Healthcare Professionals Supporting People with Insulin-Requiring Diabetes

“…In addition to the overall safety and efficacy of both commercial and open source AID systems for general populations of all ages of children and adults, additional evidence demonstrates their safety in many subpopulations and use cases, such as in young children [11,12] and older adults [13], during fasting [14], and during pregnancy [15,16].…”