Trial · NCT03800875
Insulin-plus-pramlintide Closed-loop Strategy to Regulate Glucose Levels Without Carbohydrate Counting
NCT03800875, Phase 2, Completed, McGill University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Insulin-plus-pramlintide Closed-loop Strategy to Regulate Glucose Levels Without Carbohydrate Counting. Trials, record NCT03800875. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03800875
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Insulin-plus-pramlintide Closed-loop Strategy to Regulate Glucose Levels Without Carbohydrate Counting
- NCT number
- NCT03800875
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 24 participants, actual
- Lead sponsor
- McGill University
- Conditions
- Diabetes Mellitus, Type 1
- Interventions
- 27-hour inpatient intervention
- First posted
- 2019-01-11
- Last updated
- 2021-06-08
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total percentage of time (22:00-22:00) that the glucose concentration remained within 3.9 and 10.0 mmol/L | 24 hours | |
| Secondary | Total percentage of time (22:00-22:00) that the glucose concentration remained within specified ranges. | 24 hours | a. between 3.9 and 7.8 mmol/L; b. below 3.9 mmol/L; c. between 3.9 and 10 mmol/L d. below 3.3 mmol/L; e. below 2.8 mmol/L; f. above 7.8 mmol/L; g. above 10 mmol/L; h. above 13.9 mmol/L; i. above 16.7 mmol/L. |
| Secondary | Percentage of overnight time (24:00-8:00) that the glucose concentration remained within specified ranges. | 8 hours | a. between 3.9 and 7.8 mmol/L; b. between 3.9 and 10 mmol/L; c. below 3.9 mmol/L; d. below 3.3 mmol/L; e. below 2.8 mmol/L; f. above 7.8 mmol/L; g. above 10 mmol/L; h. above 13.9 mmol/L; i. above 16.7 mmol/L. |
| Secondary | Total amount of insulin delivered to the participant | 24 hours | |
| Secondary | Mean sensor glucose concentration during the overnight stay | 8 hours | |
| Secondary | Number of participants experiencing hypoglycemia requiring oral treatment during: a. the overall study period; b. the night; c. the day | 27 hours | |
| Secondary | The number and severity of gastrointestinal sysmptoms experienced by a participant | 27 hours | GI symptoms include: nausea, vomiting, bloating and heartburn |
| Secondary | Mean daytime insulin concentration | 14 hours | |
| Secondary | Mean daytime concentration of amylin | 14 hours | |
| Secondary | Total amount of pramlintide delivered to the participant | 24 hours |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34580055 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03800875
GET https://conductscience.org/api/trials/v1/NCT03800875/registered