medwireNews: Use of the MiniMed 780G advanced hybrid closed-loop (AHCL) system leads to greater reductions in glycated hemoglobin (HbA1c) levels than conventional treatment in people with poorly controlled type 1 diabetes, ADAPT study data show.
Ohad Cohen (Medtronic International Trading Sàrl, Tolochenaz, Switzerland) and co-investigators say their findings “support wider access to AHCL in people with type 1 diabetes not at target glucose levels.”
They report in The Lancet Diabetes & Endocrinology that mean HbA1c fell from 9.0% (75 mmol/mol) at baseline to 7.3% (56 mmol/mol) at 6 months among 41 adults (mean age 42 years) with type 1 diabetes (mean duration 19 years) who were randomly assigned to use the 780G system for 6 months.
All of the participants had previously been using multiple daily injections (MDI) plus intermittently scanned continuous glucose monitoring (isCGM) for at least 3 months and had to have an HbA1c of at least 8.0% (64 mmol/mol) to be included in the study.
By comparison, mean HbA1c fell from 9.1% (76 mmol/mol) to 8.9% (74 mmol/mol) in the 41 participants (mean diabetes duration 18 years) who were randomly assigned to continue with MDI plus isCGM for 6 months.
The model-based difference in treatment effect between the two groups – a 1.5% percentage point (16 mmol/mol) greater reduction in HbA1c with the 780G system – was statistically significant, Cohen et al note.
In addition, the investigators found that people in the AHCL group spent significantly more time in target glycemic range (70–180 mg/dL; 3.9–10.0 mmol/L) than those in the isCGM group, at a mean of 70.6% versus 43.6%. Furthermore, the between-group difference of 27.6% was “considerably greater than the 5% increase considered to be clinically significant,” they remark.
The difference between the two groups was mainly due to the people using the 780G system spending less time in hyperglycemia (≥180 mg/dL) than those using isCGM, at a mean of 26.7% versus 53.8%.
By comparison, the time spent in hypoglycemia was 2.6% in both groups when a threshold of below 70 mg/dL was used and 0.6% and 0.7% in the AHCL and isCGM groups, respectively, at a threshold below 54 mg/dL.
There were no cases of diabetic ketoacidosis or severe hypoglycemia, and no serious adverse events related to study devices occurred in either group, and the researchers say that more participants in the AHCL group had improved Diabetes Treatment Satisfaction Questionnaire scores after 6 months than in the isCGM group.
Cohen et al conclude: “The insight gained from ADAPT, combined with that from previously published studies of other automated insulin delivery systems suggests that, particularly for patients struggling to achieve good glycaemic control, AHCL could represent a valuable treatment option.”
They add: “The combined benefits in terms of HbA1c, time-in-range, patient reported outcomes, and the potential long-term implications of this further suggest that AHCL should be considered early in the course of the disease when the use of multiple daily injections of insulin plus [intermittently scanned] CGM fails to achieve targets.”
In an accompanying comment, Peter Jacobs, from Oregon Health and Science University in Portland, USA, agrees with this conclusion but says that “[m]ore work is needed to assess the economic burden of closed-loop therapies compared with isCGM plus multiple daily injections.”
He believes that the findings highlight “the importance of comparing these cost differences to make closed-loop therapy more broadly reimbursable to people currently on isCGM and multiple daily injections with poorly controlled glucose.”
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Lancet Diabetes Endocrinol 2022; doi:10.1016/S2213-8587(22)00212-1
Lancet Diabetes Endocrinol 2022; doi:10.1016/S2213-8587(22)00245-5