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Can a math model tune insulin pumps better than standard care?

NCT ID NCT04572009

Disease control Sponsor: Nantes University Hospital Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Researchers at Nantes University Hospital are testing a computer model that describes how glucose and insulin interact in people with type 1 diabetes. The model aims to help doctors choose insulin pump settings, including basal rate, insulin sensitivity, and carbohydrate ratios. In this pilot study, 37 adults with type 1 diabetes who use an insulin pump and a continuous glucose sensor are randomly assigned to have their pump settings set either the usual way or with help from the model. The main measure is how much time participants spend with blood sugar in the target range of 70 to 180 mg/dL over four weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a bio-mathematical computer model that helps doctors set insulin pump settings
What this could lead to
If it works, the model could give doctors a clearer way to set insulin pump doses, which may help people with type 1 diabetes spend more time in their target blood sugar range.
What could go wrong
This is a small pilot study of 37 people at one hospital, so results may not hold for everyone. The model is a decision aid, not a cure, and participants still need daily insulin and pump management.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

37 people

The number who actually took part.

Started

Jan 2021

Finished

Oct 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patient with type 1 diabetes for at least two years with an indication for sensor placement, 2. Patient patient with at least 6 months of external insulin pump therapy and using the Medtronic 640G pump with or without the Enlite® System. 3. Patient having at least 6 months experience of flexible insulin therapy, 4. Patient with HbA1c \<10% (less than 4 months' duration of testing in a medical laboratory or equivalent), 5. Patient who has been wearing a Continuous Glucose Monitoring device for at least 3 months, 6. Adult patient, 7. Patient affiliated to a Social Security or equivalent, 8. Patient who has signed Informed Consent Form. Exclusion Criteria: 1. Patient with type 2 diabetes or secondary diabetes 2. Patient with any serious medical condition that may affect participation in the study, 3. Patient benefiting from a legal protection measure, 4. Woman who is pregnant or likely to become pregnant during the course of the study, i.e., a lack of effective contraception in women of childbearing age, 5. Breastfeeding, 6. Psychological and/or physical condition that may affect the proper monitoring of study procedures, 7. Severe hypoglycemia leading to convulsions or loss of consciousness within the last 12 months, 8. Decreased hypoglycemic feelings (as judged by the clinician), 9. Impaired renal function (creatinine clearance calculated by CKD-EPI \< 30mL/min), 10. Patient who has had a pancreas transplant or pancreatic islets, 11. Persons with severe uncorrected hearing and/or visual acuity problems, 12. Insulin resistance defined by daily insulin requirements \> 1 U/kg/day in the week prior to inclusion, 13. Patient treated with oral corticosteroid therapy.

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Conditions

The condition(s) this trial relates to.

type 1 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Type 1 diabetes

Contacts and locations

Locations

  • CHU de Nantes

    Nantes, 44093, France

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