Continuous Glucose Monitoring with Geriatric Principles in Older Adults with Type 1 Diabetes and Hypoglycemia: A Randomized Controlled Trial
Objective: Continuous Glucose Monitoring (CGM) use in older adults with Type-1 Diabetes (T1D) has shown benefits. However, the impact of CGM use, coupled with simplified treatment regimens and personalized glycemic goals that are better suited for older patients with multiple comorbidities and hypoglycemia, is not known.
Research Design and Methods: Older adults (≥65 years) with T1D with hypoglycemia (≥2 episodes of hypoglycemia <70 mg/dL for ≥20 minutes over 2 weeks) who were CGM-naïve or CGM-users were randomized to intervention and control groups. The intervention consisted of the combined use of CGM with geriatric principles (adjusting goals based on overall health, and simplification of regimens based on CGM patterns and clinical characteristics) over a 6-month period. Control group received usual care by their endocrinologist. The primary endpoint was change in time <70 mg/dL from baseline to 6-months. Cost-effectiveness was calculated using a healthcare sector perspective.
Results: We randomized 131 participants(age 71±5 years; 21% ≥75 years) to intervention (n=68; CGM-users=33) or control (n=63; CGM-users=40) groups. The median change in hypoglycemia from baseline to 6-months was –2·6% in the intervention group and –0.3% in the control group(median difference –2.3%,95%Cl [–3.7%,–1.3%];P<0.001). This improvement was seen in both CGM-naïve(–2.8%,[–5.6%,–0.8%]) and CGM-users (–1.2%,[–2.7%,–0.1%]). The HbA1C did not differ between the groups (7.5% vs 7.3%). The intervention was cost-effective(ICER, $71,623/QALY).
Conclusions: In older adults with T1D and high risk of hypoglycemia, CGM use enhanced by geriatric principles can lower hypoglycemia without worsening glycemic control in a cost-effective fashion.