Smart insulin pump aims to end dangerous nighttime blood sugar swings
NCT ID NCT02438189
First seen Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time
Summary
This trial tests a smart insulin pump algorithm designed to automatically adjust insulin delivery during the night to keep blood sugar levels in a safe range. The algorithm predicts when blood sugar might drop too low and pauses insulin, and when it might rise too high, it gives extra insulin. The study involves about 30 people with type 1 diabetes who use an insulin pump, and it compares nights with the algorithm on versus off to see if it improves time in the target range and reduces dangerous highs and lows.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A smart insulin pump algorithm that automatically adjusts insulin delivery overnight to prevent blood sugar from going too high or too low.
- What this could lead to
- If successful, this could lead to a more automated insulin pump system that helps people with type 1 diabetes maintain safer blood sugar levels overnight, reducing the risk of dangerous nighttime episodes.
- What could go wrong
- This is a small, early feasibility study, so results may not apply to everyone. The algorithm may not always predict correctly, and there is a risk of severe hypoglycemia or diabetic ketoacidosis, though the trial monitors for these.
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
-
33 people
The number who actually took part.
- Started
-
Jun 2015
- Finished
-
Mar 2016
- 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
-
15 to 45 years
- 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 Hide 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: * Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one year and an insulin infusion pump for at least 6 months The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not required. * Age 15.0 to \<46.0 years * HbA1c \<10.0% * Measured with DCA2000 or equivalent device for assessing eligibility * HbA1c measurements performed as part of usual clinical care within 2 weeks prior to obtaining informed consent for participation in the trial may be used. * Uninterrupted internet access while study system is being used overnight and for upload of study data in the morning * Living with a significant other or family member ("companion") committed to participating in all study activities, and being present and available to provide assistance when the system is being used at night * An understanding of and willingness to follow the protocol and sign the informed consent Exclusion Criteria: * Diabetic ketoacidosis in the past 3 months * Hypoglycemic seizure or loss of consciousness in the past 6 months * History of seizure disorder (except for hypoglycemic seizure) * History of any heart disease including coronary artery disease, heart failure, or arrhythmias * Cystic fibrosis * Current use of oral/inhaled glucocorticoids, beta-blockers or other medications, which in the judgment of the investigator would be a contraindication to participation in the study. * History of ongoing renal disease (other than microalbuminuria). Creatinine level must have been obtained within the last year if subject has diabetes of \>10 years duration. If creatinine is \>1.5 mg/dL (132 µmol/L), the subject is excluded. * Medical or psychiatric condition that in the judgment of the investigator might interfere with the completion of the protocol such as: * Inpatient psychiatric treatment in the past 6 months * Uncontrolled adrenal disorder * Abuse of alcohol * Pregnancy Negative urine pregnancy test required for females who have experienced menarche as well as agreement from subject and parent/guardian to use a form of contraception to prevent pregnancy while participant is in the study. Subjects who become pregnant will be discontinued from the study. * Liver disease as defined by an ALT greater than 3 times the upper limit of normal
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Type 1 diabetes are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, 80045, United States
-
St. Joseph's Health Care
London, Ontario, N6A4V2, Canada
-
Stanford University
Stanford, California, 94305, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Tiny horses, big lessons: can ponies help kids tame diabetes?
- Can a math model tune insulin pumps better than standard care?
- Can a group program stop eating disorders in type 1 diabetes?
- Can a Two-Punch immune therapy save insulin cells in newly diagnosed diabetes?
- Can a smart insulin pump tailored for pregnancy protect mothers and babies?
- Can an automated pancreas system make type 1 diabetes safer in the real world?