Trial · NCT07914621
Outpatient Pramlintide Study
NCT07914621, Not applicable, Not yet recruiting, Oregon Health and Science University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Outpatient Pramlintide Study. Trials, record NCT07914621. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07914621
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Outpatient Pramlintide Study
- NCT number
- NCT07914621
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 26 participants, estimated
- Lead sponsor
- Oregon Health and Science University
- Conditions
- Type 1 Diabetes
- Interventions
- Single-hormone automated insulin delivery system, Dual-hormone automated insulin and pramlintide delivery system
- First posted
- 2026-11-03
- Last updated
- 2026-11-12
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent of time with sensed glucose between 70-180 mg/dl during the daytime | CGM measured during the daytime (06:00-23:59) hours for all days in the week when participants used the single-hormone system compared with all days in the week when participants used the dual-hormone system. | Percent of time with sensed glucose between 70-180 mg/dl during the daytime (06:00-23:59) comparing the results during the week when participants used the single-hormone insulin-only system (arm 1) versus when participants used the dual-hormone insulin and pramlintide system (arm 2). This outcome can range from 0% to 100% time with sensed glucose between 70-180 mg/dL with a higher percentage indicating better glucose control. |
| Secondary | Incremental area under the sensed glucose curve of in-clinic postprandial glucose | 6 hours following the start of standarized in-clinic meal | Incremental area under the sensed glucose curve (iAUC) of postprandial glucose as measured by CGM in the 6 hours following the start of standarized in-clinic meal. iAUC (mg/dL\*min) will be calculated using a trapezoidal method \[76\], which sums all CGM values in the 6 hour period following the meal above the starting glucose. This value can range between 0 and 144,000 mg/dL\*min with a lower iAUC indicating better glucose control. We will compare the results during the week when participants used the single-hormone insulin-only system (arm 1) versus when participants used the dual-hormone insulin and pramlintide system (arm 2). |
| Secondary | Percent of time with sensed glucose <70 mg/dl | Daytime (06:00-23:59), overnight (24:00-05:59), and over full 24-hours. | Percent of time sensed CGM glucose is less than 70 mg/dL comparing the results during the week when participants used the single-hormone insulin-only system (arm 1) versus when participants used the dual-hormone insulin and pramlintide system (arm 2).. This outcome can range from 0 to 100% with a lower value indicating better glucose control. |
| Secondary | Percent of time with sensed glucose between 70 - 140 mg/dl | Daytime (06:00-23:59), overnight (24:00-05:59), and over full 24-hours. | Percent of time with sensed glucose between 70 - 140 mg/dl comparing the results during the week when participants used the single-hormone insulin-only system (arm 1) versus when participants used the dual-hormone insulin and pramlintide system (arm 2). This outcome can take values between 0 and 100 with a higher value indicating better glucose control. |
| Secondary | Mean sensed glucose | Daytime (06:00-23:59), overnight (24:00-05:59), and over full 24-hours. | Mean of the CGM values comparing the results during the week when participants used the single-hormone insulin-only system (arm 1) versus the week when participants used the dual-hormone insulin and pramlintide system (arm 2). This outcome can take values between 40 and 400 mg/dL with a lower value indicating better glucose control. |
| Secondary | Coefficient of variation of sensed glucose | Daytime (06:00-23:59), overnight (24:00-05:59), and over full 24-hours. | Coefficient of variation of CGM comparing the results during the week when participants used the single-hormone insulin-only system (arm 1) versus the week when participants used the dual-hormone insulin and pramlintide system (arm 2). This outcome can take values between 0 and 100% with a lower value indicating better glucose control. |
| Secondary | Percent of time with sensed glucose <54 mg/dl | Daytime (06:00-23:59), overnight (24:00-05:59), and over full 24-hours. | Percent of time that sensed glucose is less than 54 mg/dL comparing the results during the week when participants used the single-hormone insulin-only system (arm 1) versus the week when participants used the dual-hormone insulin and pramlintide system (arm 2). This outcome can take values between 0 and 100% with a lower value indicating better glucose control. |
| Secondary | Percent of time with sensed glucose >180 mg/dl | Daytime (06:00-23:59), overnight (24:00-05:59), and over full 24-hours. | Percent of time that sensed glucose is less than 180 mg/dL comparing the results during the week when participants used the single-hormone insulin-only system (arm 1) versus the week when participants used the dual-hormone insulin and pramlintide system (arm 2). This outcome can take values between 0 and 100% with a lower value indicating better glucose control. |
| Secondary | Percent of time with sensed glucose >250 mg/dl | Daytime (06:00-23:59), overnight (24:00-05:59), and over full 24-hours. | Percent of time that sensed glucose is \>250 mg/dL comparing the results during the week when participants used the single-hormone insulin-only system (arm 1) versus the week when participants used the dual-hormone insulin and pramlintide system (arm 2). This outcome can take values between 0 and 100% with a lower value indicating better glucose control. |
| Secondary | Mean amount of insulin delivered (in units and units/kg) | Daytime (06:00-23:59), overnight (24:00-05:59), and over full 24-hours. | Mean amount of insulin delivered in units and units/kg comparing the results during the week when participants used the single-hormone insulin-only system (arm 1) versus the week when participants used the dual-hormone insulin and pramlintide system (arm 2). This outcome can take values between 0 and 200 units with a lower value indicating lower insulin requirements. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01DK129382 | Enabling Fully Automated Closed Loop Control in Type 1 Diabetes Through an Artificial Intelligence Meal Detection Algorithm and Pramlintide | JACOBS, PETER G; WILSON, LEAH MEGAN | OREGON HEALTH & SCIENCE UNIVERSITY | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 2021 to 2024 |
Source NIH RePORTER
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/NCT07914621
GET https://conductscience.org/api/trials/v1/NCT07914621/registered