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Alleviating Carbohydrate Counting for Patients With Type 1 Diabetes Using a Novel Insulin-plus-pramlintide Artificial Pancreas
Alleviating Carbohydrate Counting for Patients With Type 1 Diabetes Using a Novel Insulin-plus-pramlintide Artificial Pancreas: a Randomized Controlled Crossover Trial.
Lead sponsor
Asset
Pramlintide
Amylin analog
Listed sites
1
Recruiting sites
—
Enrollment
36
actual
Study population
Type 1 diabetes
Key I/E criterion
•HbA1c ≤12%
Primary endpoints
•CGM time-in-range•Mean score of the Emotional Burden section of the Diabetes Distress Scale
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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Signed and dated written informed consent
2. Males and females ≥ 12 years of age
3. HbA1c ≤ 12%
4. Insulin pump use for at least 3 months
5. Clinical diagnosis with type 1 diabetes for at least 12 months. The diagnosis of T1D is based on the investigator's clinical judgment; C peptide level and antibody determinations are not planned.
6. Women of child-bearing potential must be ready and able to use a highly effective method of birth control. Women of childbearing potential are females who have experienced [the first occurrence of menstruation] and do not meet the criteria for women not of childbearing potential. Women not of childbearing potential are females who are permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause.
Exclusion criteria
Participants who meet any of the following criteria are not eligible for the study:
1. Current or ≤ 1 month use of other antihyperglycemic agents (SGLT2 inhibitors, GLP-1 agonists, Metformin, Acarbose, etc.…).
2. Current use of glucocorticoid medication.
3. Use of medication that alters gastrointestinal motility.
4. Planned or ongoing pregnancy.
5. Breastfeeding individuals.
6. Severe hypoglycemic episode within one month of admission.
7. Severe diabetes ketoacidosis episode within one month of admission.
8. Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
9. Recent (< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
10. Known hypersensitivity to any of the study drugs or their excipients.
11. Individuals with confirmed gastroparesis.
12. Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
13. Unable to travel to research center within 3h if needed during study interventions
14. Failure to comply with team's recommendations (e.g. not willing to eat meals/snacks, not willing to change pump parameters, etc.).
Study Discontinuation/Withdrawal
1. Failure to comply with the protocol.
2. Pregnancy.
3. After an event which the PI believes it is not in the best interest for the patient to continue the trial.
Endpoints (11)
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
7 endpointsEach participant's time in target range
Time frame:12 days
CGM time-in-range
descriptive, improvement
Each participant's percentage of time of glucose levels spent between 3.9 and 7.8 mmol/L
Time frame:12 days
CGM time-in-range
descriptive, improvement
Each participant's percentage of time of glucose levels spent between 3.9 and 10 mmol/L
Time frame:12 days
CGM time-in-range
percent change from baseline, improvement
Each participant's percentage of time of glucose levels spent below 3.9, 3.3, and 2.8 mmol/L
Time frame:12 days
CGM time-below-range
descriptive, improvement
Each participant's percentage of time of glucose levels spent above 7.8, 10, 13.9 and 16.7 mmol/L
Time frame:12 days
CGM time-above-range
descriptive, improvement
Each participant's mean glucose level
Time frame:12 days
descriptive, improvement
Each participant's standard deviation of glucose levels as a measure of glucose variability
Time frame:12 days
descriptive
Patient-reported / QoL
1 endpointMean score of the Emotional Burden section of the Diabetes Distress Scale
Time frame:12 days
descriptive, improvement
Safety / tolerability / PK
2 endpointsEach participant's number of hypoglycemia events defined as at least 15 min below 3.0 mmol/L
Time frame:12 days
Documented hypoglycemia
event count, event
Each participant's number of Gastrointestinal symptoms
Time frame:12 days
event count, event
Other (unclassified)
1 endpointEach participant's total insulin delivery
Time frame:12 days
descriptive
Publications (1)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- The Lancet. Digital health2024 Jul (month)PMID38906614doi:10.1016/S2589-7500(24)00092-Xvia clinicaltrials gov reference derived + pubmed nct search
Provenance
Sources
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.