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TOPLINE:

In adult patients with poorly controlled type 1 diabetes (T1D) on insulin pumps and continuous glucose monitoring (CGM), a switch to automated insulin delivery (AID) systems may confer considerable glycemic benefits within 14 weeks.

METHODOLOGY:

• Even with insulin pumps and CGM, many patients with T1D are unable to achieve and maintain A1c ≤ 7% (53 mmol/mol), which is crucial to prevent or delay complications.
• This open-label randomized controlled trial assessed the effects of an AID system on 40 participants (mean age, 52 years; 45% men; diabetes duration, 29 years; mean A1c, 8.3%) recruited from the outpatient clinic at Steno Diabetes Center Copenhagen between June 2021 and September 2022.
• The participants were randomly assigned to treatment with MiniMed 780G (Medtronic, United States) (AID group; n = 20) or to their usual care with an insulin pump and CGM (usual care group; n = 20) for 14 weeks, after which all participants from both groups were treated with AID for another 14 weeks.
• The primary outcome was the difference between treatment groups in the change in time in range (TIR) (3.9-10.0 mmol/L) from baseline to week 14, as assessed using 2 weeks of CGM data.
• The secondary outcomes were the change in A1c and mean sensor glucose levels, differences in the change in times above and below range, and other glycemic parameters.

TAKEAWAY:

• At week 14, the TIR increased by 18.7% in the AID group vs −2.1% in the usual care group (P < .0001). TIR > 70% was achieved by 80% participants in the AID group and by 10% in the usual care group.
• Similarly, time in extreme hyperglycemia, mean sensor glucose levels, and A1c levels (all P < .0001) decreased more prominently in the AID group than in the usual care group, with no reported episodes of severe hypoglycemia during the study.
• At week 14, patient-reported outcomes were better in the AID group than in the usual care group, as measured by the Diabetes Treatment Satisfaction Questionnaire score, perceived frequency of hyperglycemia, and fear of hypoglycemia.
• At week 28, TIR and A1c levels in the usual care group similarly improved after the week 14 switch to AID, while these glycemic parameters remained stable in the AID group.

IN PRACTICE:

"These findings support integrating AID use as standard of care in adults with type 1 diabetes struggling to reach glycemic targets regardless of prior technology use," the authors wrote.

SOURCE:

This investigation, led by Merete B. Christensen, MD, PhD, from Copenhagen University Hospital, Steno Diabetes Center Copenhagen, Herlev, Denmark, was published in the Journal of Diabetes Science and Technology.

LIMITATIONS:

The trial period was not long enough to detect rare adverse events. The results may not be generalizable owing to the sparse ethnic diversity of the included population. Only participants who used a daily bolus calculator were included.

DISCLOSURES:

The investigator-initiated study was supported in part by an unrestricted grant from Medtronic A/S. Some authors declared receiving speaker honorarium and speaker fees, honorarium for advisory board membership, consultancy fees and holding shares from pharmaceutical and medical technology companies. One author reported employment with Novo Nordisk during the conduct of the study.