DelfaGLP-1 Atlas

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FCL

UnknownPhase 2, PHASE3

A Fully Automated Lyumjev and Pramlintide Delivery System for Adults With Type 1 Diabetes

A Randomized, Controlled, Crossover Trial to Assess a Fully Automated, Dual-hormone (Insulin-and-pramlintide) Delivery System Without Carbohydrate Counting in Regulating Glucose Levels in Adults With Type 1 Diabetes.

Asset

Pramlintide

Amylin analog

Listed sites

1

Recruiting sites

1

Enrollment

30

estimated

Study population

Type 1 diabetes

Key I/E criterion

—

Primary endpoint

•CGM time-in-range

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06046417
Org study ID2023-9373

Timeline

Milestones

Study first posted2023-09-21actual
Study start2023-11-30actual
Last update posted2024-04-18actual
Primary completion2025-04estimated (month precision)
Study completion2025-06estimated (month precision)

Assets

Investigational agents

Pramlintide

Study populations

Who this study enrolls

Type 1 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Individuals ≥ 18 years of age.
•A clinical diagnosis of type 1 diabetes for at least 12 months. The diagnosis of type 1 diabetes relies on the investigator's judgment; C peptide level and antibody determinations are unnecessary.
•Using insulin pump therapy for at least three months.
•Individuals of childbearing potential using an effective birth-control method. An individual of childbearing potential must agree to use a highly effective method of birth control.

Exclusion criteria

•Current or recent use of antihyperglycemic agents other than insulin (≤ 2-week use of sodium-glucose cotransporter-2 inhibitor (SGLT2I), Metformin, etc.; ≤ 1-month for glucagon-like peptide-1 receptor agonists (GLP1-RA)).
•Current use of glucocorticoid medication (except low, stable doses and inhaled steroids).
•Individuals with confirmed gastroparesis.
•Use of medication that alters gastrointestinal motility (ex: domperidone).
•Use of hydroxyurea.
•Planned or ongoing pregnancy.
•Breastfeeding individuals.
•Severe hypoglycemia requiring hospitalization in the past month. Severe hypoglycemia is defined as requiring the assistance of another person, due to altered consciousness, to administer carbohydrates, glucagon, or other resuscitative actions.
•Diabetic ketoacidosis episode in the past month.
•Clinically significant nephropathy, neuropathy, or retinopathy as judged by the investigator.
•Recent (< 6 months) acute macrovascular event, e.g., acute coronary syndrome.
•Other serious medical illnesses which are likely to interfere with study participation or the ability to complete the trial by the investigator's judgment.
•Known hypersensitivity to the study drugs or their excipients.

Endpoints (16)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes
8
Patient-reported / QoL
5
Safety / tolerability / PK
2
Other (unclassified)
1

Glycemic / diabetes

8 endpoints
Primary/protocol endpoint

Percentage of time of glucose levels spent in the target range (3.9-10.0 mmol/L).

Time frame:18 days

CGM time-in-range

descriptive, improvement

Secondary/protocol endpoint

Percentage of time of glucose levels spent between 3.9-7.8 mmol/L.

Time frame:18 days

CGM time-in-range

descriptive, improvement

Secondary/protocol endpoint

Percentage of time of glucose levels spent between 3.0-3.9 mmol/L.

Time frame:18 days

CGM time-below-range

descriptive, improvement

Secondary/protocol endpoint

Percentage of time of glucose levels spent between 10.0-13.9 mmol/L.

Time frame:18 days

CGM time-above-range

descriptive, improvement

Secondary/protocol endpoint/low confidence

Mean glucose levels.

Time frame:18 days

descriptive, improvement

Secondary/protocol endpoint

Standard deviation of glucose levels.

Time frame:18 days

descriptive, improvement

Secondary/protocol endpoint

Coefficient of variance of glucose levels.

Time frame:18 days

descriptive, improvement

Secondary/protocol endpoint/low confidence

Total insulin delivery (overall, basal, and bolus).

Time frame:18 days

descriptive

Patient-reported / QoL

5 endpoints
Secondary/protocol endpoint

Mean score on the Type 1 Diabetes Distress Scale (T1DDS) excluding the physician subscale.

Time frame:18 days

descriptive, improvement

Secondary/protocol endpoint

Mean score on the Hypoglycemia Fear Survey - II (Worry Subscale) (HSF2).

Time frame:18 days

descriptive, improvement

Secondary/protocol endpoint

Mean score on the INSPIRE questionnaire for adults (INSPIRE).

Time frame:18 days

descriptive, improvement

Secondary/protocol endpoint

Mean score on selected items from The Diabetes Bowel Symptoms Questionnaire (DBSQ).

Time frame:18 days

descriptive, improvement

Secondary/protocol endpoint

Mean score on a Treatment Satisfaction Questionnaire (TSQ) taken from Marrero et al.

Time frame:18 days

descriptive, improvement

Safety / tolerability / PK

2 endpoints
Secondary/protocol endpoint

Total pramlintide delivery (overall, basal, and bolus).

Time frame:18 days

descriptive

Other/protocol endpoint

Safety Endpoints

Time frame:18 days

Treatment-emergent AEs (any)

event count, event

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Thematic interview analysis

Time frame:18 days

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.