Trial · NCT07914621
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| 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. |
| Secondary | Mean amount of pramlintide delivered (in mcg and mcg/kg) | Daytime (06:00-23:59), overnight (24:00-05:59), and over full 24-hours. | Mean amount of pramlintide delivered in mcg and mcg/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 1200 mcg, with lower values indicating lower insulin and pramlintide requirements. |
| Secondary | Percent of time with sensed glucose between 70-180 mg/dl | Daytime (06:00-23:59), overnight (24:00-05:59), and over full 24-hours. | Percent of time with sensed glucose between 70-180 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 lower values indicating lower insulin and pramlintide requirements. |
| Secondary | Number of adverse events probably or possibly associated with Pramlintide administration | Entire study duration. | An AE is any clinically significant undesirable experience (sign, symptom, illness, or other medical event) meeting the causality definition above that appears or worsens in a participant during a clinical study. A clinically significant event is any event (sign, symptom, lab/imaging abnormality, or diagnosis) that is noteworthy enough to merit documentation in standard medical records (e.g. history and physical, progress notes, clinic visit notes, etc.). Other non-clinically significant events (e.g. colds, minor headaches, etc.) may be documented on the comments CRF. Mild hypoglycemia is expected in persons with diabetes using insulin and are typically self-limiting in nature; thus, this will not be captured as an AE. |
| Secondary | Baxter Retching Faces (BARF) scale for standardized in-clinic meal | 6 hours after completion of in-clinic meal and at conclusion of the dual-hormone insulin and pramlintide arm of the study. | Participants will fill out the BARF questionnaire 6 hours after first in-clinic meal and at conclusion of the insulin + pramlintide dual-hormone arm of the study. A higher BARF score indicates more nausea. |
| Secondary | Mean duration of gastrointestinal issues after standardized in-clinic meal as reported by participant on BARF VAS scale | 6 hours after completion of in-clinic meal and at conclusion of the dual-hormone insulin and pramlintide arm of the study. | Participants will fill out the BARF questionnaire 6 hours after first in-clinic meal and at conclusion of the insulin + pramlintide dual-hormone arm of the study. A longer duration of gastrointestinal issues indicates a worse outcome. |
| Secondary | Episodes of carbohydrate intake to treat hypoglycemia | Daytime (06:00-23:59), overnight (24:00-05:59), and over full 24-hours. | We will count the average times that person takes carbohydrates to treat hypoglycemia 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 about 24, with lower values indicating reduced risk of hypoglycemia. |
| Secondary | Mean number of low glucose events / day | Daytime (06:00-23:59), overnight (24:00-05:59), and over full 24-hours. | We will count the number of low glucose events / day whereby a single low glucose event is defined to start when the CGM drops below 70 mg/dL for at least three measurements and ends when the CGM rises above 69 mg/dL for at least three measurements. We will compare 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 about 24, with lower values indicating reduced risk of hypoglycemia. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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