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NCT07914621

Outpatient Pramlintide Study

StatusNot Yet Recruiting
PhaseNot applicable
Primary completion (estimated)
Track this trial

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Record History

All 2 versions: 2 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary endpoint(s) modified
    • Interventions modified
    • Secondary endpoints: 17 to 16
    • Study description expanded, about 1,858 words
  2. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Percent of time with sensed glucose between 70-180 mg/dl during the daytime
Timeframe: 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.

Secondary (16)

Incremental area under the sensed glucose curve of in-clinic postprandial glucose
Percent of time with sensed glucose <70 mg/dl
Percent of time with sensed glucose between 70 - 140 mg/dl
Mean sensed glucose
Coefficient of variation of sensed glucose
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Percent of time with sensed glucose <54 mg/dl
Percent of time with sensed glucose >180 mg/dl
Percent of time with sensed glucose >250 mg/dl
Mean amount of insulin delivered (in units and units/kg)
Mean amount of pramlintide delivered (in mcg and mcg/kg)
Percent of time with sensed glucose between 70-180 mg/dl
Number of adverse events probably or possibly associated with Pramlintide administration
Baxter Retching Faces (BARF) scale for standardized in-clinic meal
Mean duration of gastrointestinal issues after standardized in-clinic meal as reported by participant on BARF VAS scale
Episodes of carbohydrate intake to treat hypoglycemia
Mean number of low glucose events / day

Arms and interventions

Single-hormone automated insulin deliveryExperimental

Participants will use a single-hormone automated insulin delivery system to manage their glucose levels. The system comprises an Google Pixel smart phone, a Dexcom G6 continuous glucose monitor, an Insulet Omnipod Dash pump filled with insulin, and a Google Pixel smart watch to capture exercise.

Dual-hormone automated insulin and pramlintide deliveryExperimental

Participants will use the closed loop system with insulin and pramlintide for managing blood sugar for 1 week. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM.

Devices: Single-hormone automated insulin delivery system, Dual-hormone automated insulin and pramlintide delivery system