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New CGM algorithm could simplify insulin dosing for diabetes

NCT ID NCT06111508

Disease control Sponsor: University of Virginia Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study tested a new computer algorithm that uses continuous glucose monitor (CGM) readings to automatically suggest the right dose of long-acting insulin for people with type 2 diabetes. Thirty adults already using basal insulin were followed for 18 weeks to see if the algorithm improved blood sugar control compared to standard self-monitoring. The goal was to increase the time blood sugar stays in a healthy range without causing dangerous lows.

What this could mean

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

Active substance
Continuous glucose monitor (CGM) and degludec insulin
What this could lead to
If successful, this could lead to a simpler, more effective way for people with type 2 diabetes to manage their blood sugar using a CGM-based insulin dosing guide.
What could go wrong
This is a small, early pilot study with only 30 participants, so results may not apply to everyone. The algorithm may not improve blood sugar control more than standard methods.

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

30 people

The number who actually took part.

Started

Nov 2023

Finished

Sep 2024

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. Age 18 years or older at signing of informed consent 2. Diagnosis of Type 2 Diabetes minimum 180 days before the day of screening 3. Hemoglobin A1c between 7-9% and measured by local lab at screening 4. On daily basal insulin for at least 90 days before inclusion into the study 5. Stable dose of oral and injectable (other than insulin) antidiabetic medications for 90 days prior inclusion. Acceptable medications include: 1. Metformin 2. Sulfonylureas 3. Meglitinides (glinides) 4. Dipeptidyl peptidase 4 (DPP-4) inhibitors 5. Sodium glucose co-transporter 2 (SGLT2) inhibitors 6. Thiazolidinediones 7. Alpha-glucosidase inhibitors 8. Oral combination products (for the allowed individual oral anti-diabetic drugs) 9. Oral or injectable Glucagon-like peptide-1 (GLP-1) Receptor Agonists (RAs) 10. If on sulfonylureas or glinides, willingness to reduce dose by 50% Exclusion Criteria 1. Hypersensitivity to Degludec 2. Use of an insulin pump 3. Use of a short-acting insulin 4. Participation or has participated in another trial within 90 days of the screening visit 5. Female who is pregnant or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method 6. Any disorder, except for conditions associated with T2D, which in the investigator's opinion might jeopardize participant's safety or compliance with the protocol. 7. Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days of the screening visit 8. Known skin reactions to CGM adhesives 9. Current/prior use of CGM within 30 days of the screening visit 10. Any planned surgery or procedures where basal insulin would be decreased or held in anticipation

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

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

Type 2 diabetes

Contacts and locations

Locations

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • University of Virginia

    Charlottesville, Virginia, 22903, United States

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