What the trial was testing
The ONWARDS 6 enrolled 582 patients with type 1 diabetes. The study was sponsored by Novo Nordisk A/S and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was a large trial designed to confirm whether the treatment works well enough for wider use. Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
The weekly insulin caused 1.9 times more low blood sugar events than the daily insulin.
Lancet (London, England) · 2023 · NCT04848480
These findings — that the weekly insulin caused nearly twice as many dangerous low blood sugar episodes compared to daily insulin — were published in the Lancet (London, England) and represent the headline result of the study.
Researchers tracked outcomes across 582 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with type 1 diabetes, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
This was a large-scale study, but the weekly insulin is not yet FDA-approved. The higher rate of low blood sugar episodes is a concern that doctors will need to consider. If you have type 1 diabetes, talk with your doctor about whether once-weekly insulin options might become available and whether they'd be right for you.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open type 1 diabetes trials
A Study of LY3938577 in Healthy Participants and Participants With Type 1 Diabetes Mellitus (T1DM)
The main purpose of this study is to look at the amount of the study drug LY3938577 that gets into the blood stream and how long it takes the body to get rid of it. At a later stage of this study (part B and C) the blood sugar lowering effect and the duration of action of LY3938577 will be evaluated compared to Insulin Degludec. The study will also evaluate the safety and tolerability of LY3938577 and information about any side effects experienced will be collected. The study will be conducted in four parts (A, B, C, and D). Healthy participants in Part A Period 1 will receive a single dose of LY3938577 or a placebo given via intravenous (IV) infusion. In Part A Period 2, participants will receive a single subcutaneous (SC) dose of either LY3938577 or placebo. Participants in Part B with Type 1 Diabetes Mellitus (T1DM) will receive single doses of either LY3938577 or Insulin Degludec given via IV infusion. Participants in Part C with Type 1 Diabetes Mellitus (T1DM) will receive two doses of either LY3938577 or Insulin Degludec administered SC. Participants in Part D with Type 1 Diabetes Mellitus (T1DM) will be evaluated in 2 periods, with Period 1 administered pre-study basal insulin and lispro mealtime insulin to establish insulin needs, and Period 2 administered lispro mealtime insulin and daily doses of LY3938577. The study will last up to approximately 11 weeks for Part A, 10 weeks for Part B, 13 weeks for Part C, and 10 weeks for Part D , including screening period.
Influence of Menstrual Cycle Phases on the Glycemic Control of Aerobic or HIIT Exercise in Adult Women With Type 1 Diabetes
Continuous glucose monitors, as a technology that aims to improve glycaemic control in patients with type 1 diabetes, must always adjust to changes in blood glucose levels in these patients, e.g. during sporting activities. In women, in particular, menstruation and its different phases can affect blood glucose levels in different ways. Therefore, this study aims to determine whether there is a different behaviour of blood glucose levels during aerobic or high-intensity exercise in different phases of menstruation. If so, we will try to model this behaviour and create specific guidelines in this regard in terms of physical exercise programming in women. In addition, the information derived from this study will be used to design better artificial pancreas systems that take into account the effects of the menstrual cycle in women.