Understanding Artificial Pancreas Systems: Results from a 24-Month Trial

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HbA1c fell from 8.03% at baseline to 7.62% at end-of-treatment, then remained below baseline at 7.74% after treatment stopped. This suggests better average glucose control during the 8-week treatment period, although the single-arm design lowers confidence in the size of benefit.

Continuous glucose monitoring showed modest improvement in overall glycemic exposure during treatment and clearer worsening after empagliflozin was withdrawn. The improvement appeared stronger overnight than during daytime hours, suggesting a more prominent effect on nighttime glucose patterns.

Glycemic variability showed a trend toward improvement during treatment and worsened after the drug was stopped. Some sensitivity measures supported improvement more clearly than the main variability measure, so the direction appears favorable but the strength of evidence is mixed.

Time spent in the target glucose range increased numerically from 40.2% to 43.1% during treatment, then dropped after treatment ended. This points toward a benefit, but the change during treatment was modest and not clearly significant in the overall cohort.

The percentage of time spent below 70 mg/dL was similar at baseline, end-of-treatment, and post-treatment. That suggests empagliflozin did not clearly increase low-glucose exposure in this study, but the sample was small and the paper notes differences between CGM findings and prior symptom-based reports.

Total daily insulin dose decreased from 54.7 units at baseline to 45.8 units at end-of-treatment, then returned close to baseline after treatment stopped. The reduction was mainly driven by lower basal insulin requirements, suggesting empagliflozin reduced insulin needs during active treatment.

Empagliflozin 25 mg taken once daily for 8 weeks as add-on therapy to insulin in adults with type 1 diabetes, with initial 30% reductions in both basal and prandial insulin followed by guided dose adjustments.

Continuous glucose monitoring showed modest improvement during treatment and worsening after empagliflozin was stopped

Nighttime glycemic exposure fell more than daytime exposure during treatment

Time spent in low glucose did not clearly increase during treatment

Empagliflozin appears to have helped glucose control in this small type 1 diabetes study, especially overnight, while allowing lower insulin doses. The rebound after stopping treatment supports a real drug effect. Even so, the uncontrolled design means the size of benefit is uncertain, and the findings should be viewed as early signal-generating evidence rather than definitive proof.

Participants added empagliflozin 25 mg once daily to ongoing insulin therapy. At treatment initiation, both prandial and basal insulin were reduced by 30% as a safety measure, with later adjustments guided by glucose readings. The study included both insulin pump users and people using multiple daily injections.

Perkins BA, Cherney DZI, Soleymanlou N, et al. Diurnal Glycemic Patterns during an 8-Week Open-Label Proof-of-Concept Trial of Empagliflozin in Type 1 Diabetes. PLoS One. 2015;10(11):e0141085. doi:10.1371/journal.pone.0141085

HbA1c improved over 8 weeks of empagliflozin treatment. Continuous glucose monitoring suggested lower overall glycemic exposure during treatment and a clearer worsening after treatment stopped. The nighttime glucose pattern improved more than the daytime pattern. Glycemic variability improved by some measures, while time in target rose modestly and time spent in low glucose stayed broadly similar. Total daily insulin and basal insulin doses both fell during treatment.

Single-arm open-label design with no control group

Most CGM findings were trends rather than strong between-period effects

In a small 8-week study of adults with type 1 diabetes, empagliflozin lowered HbA1c and appeared to improve nighttime glucose patterns while reducing insulin needs, without increasing time spent in low blood sugar.

This study was small, short, and exploratory. It had no parallel control group, so changes could partly reflect closer monitoring, behavior changes, or regression to the mean rather than the drug itself. Participants and investigators knew treatment was being given, which can influence insulin adjustment and reporting. The paper also focused on continuous glucose monitoring patterns rather than hard clinical outcomes. Most findings outside HbA1c were numerical trends rather than clear treatment differences, and the subgroup analyses for pump and injection users were especially underpowered.

HbA1c ↓ from 8.03% to 7.62% during treatment

Blood glucose patterns improved more at night than during the day

Total daily insulin dose ↓ by about 17%, mainly from lower basal insulin

The ADA Standards of Care outline current evidence-based recommendations for type 1 diabetes management, including use of continuous glucose monitoring, insulin adjustment, and careful evaluation of adjunctive therapies that may affect glycemia or hypoglycemia risk.

American Diabetes Association Standards of Care in Diabetes—2025

Adults with type 1 diabetes completed a 2-week placebo run-in period, 8 weeks of open-label empagliflozin 25 mg once daily, and a 2-week post-treatment follow-up. Participants used continuous glucose monitoring throughout the study. Investigators compared ambulatory glucose profile measures, HbA1c, and insulin doses across baseline, end-of-treatment, and post-treatment intervals. Insulin doses were reduced at treatment start and then adjusted using capillary glucose data.

This earlier report from the same empagliflozin pilot program found improved glycemic control in type 1 diabetes over 8 weeks and provides context for the present paper’s deeper analysis of continuous glucose monitoring patterns and insulin dose changes.

Sodium-glucose cotransporter 2 inhibition and glycemic control in type 1 diabetes: results of an 8-week open-label proof-of-concept trial

This pilot trial of dapagliflozin in type 1 diabetes provides related evidence that SGLT2 inhibition may improve glucose measures in people using insulin, while also highlighting the need for careful insulin adjustment and safety monitoring.

Exploring the potential of the SGLT2 inhibitor dapagliflozin in type 1 diabetes: a randomized, double-blind, placebo-controlled pilot study

Empagliflozin may improve nighttime blood sugar patterns in type 1 diabetes

This study tested empagliflozin as an add-on to insulin in adults with type 1 diabetes. Over 8 weeks, HbA1c improved, insulin doses fell, and glucose patterns looked better at night than during the day. Time spent in low blood sugar did not clearly increase, but the study was small and did not include a control group.

This study does not prove that empagliflozin is broadly safe or effective for all people with type 1 diabetes. It was industry funded, open label, and exploratory. The paper also gives limited information here on uncommon but important risks such as ketoacidosis. Any use of this kind of therapy in type 1 diabetes needs careful clinical supervision and individualized insulin adjustment.

Empagliflozin added to insulin in adults with type 1 diabetes using continuous glucose monitoring

This study involved adults with type 1 diabetes who were normotensive and normoalbuminuric, with HbA1c between 6.5% and 11.0%. About two-thirds used insulin pumps and one-third used multiple daily injections. The findings may be most relevant to relatively young adults with uncomplicated type 1 diabetes receiving intensive insulin therapy.

Empagliflozin may improve nighttime blood sugar patterns in type 1 diabetes

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Sources

American Diabetes Association Standards of Care in Diabetes—2025

Sodium-glucose cotransporter 2 inhibition and glycemic control in type 1 diabetes: results of an 8-week open-label proof-of-concept trial

Exploring the potential of the SGLT2 inhibitor dapagliflozin in type 1 diabetes: a randomized, double-blind, placebo-controlled pilot study

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