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Trial · Interventional

CompletedNot applicableResults postedRegistry data

Two Way Crossover Closed Loop Study Insulin vs Insulin and Pramlintide

NCTNCT06422325 (opens ClinicalTrials.gov in a new tab)Other idSTUDY00025279Other id5R01DK129382-03
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
33 participants (actual)
Sponsor
Oregon Health and Science University · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
12 Jul 2024
Primary completion
4 Jan 2025
Completion
28 Jan 2025
First posted
20 May 2024
Last update posted
9 Jun 2026
Conditions
Type 1 Diabetes

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202420252026
  1. N/A

    Two Way Crossover Closed Loop Study Insulin vs Insulin and Pramlintide

    NCT06422325

    12 Jul 2024 to 28 Jan 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this study is to test how well a new investigational closed loop system manages your blood sugar with the ability to deliver insulin and pramlintide. Pramlintide is a drug that is used with mealtime insulin to control blood sugar in people who have diabetes. It works by slowing down the movement of food through the stomach which prevents blood sugar from rising too high after a meal. The closed loop system will receive glucose values from the Dexcom G6 continuous glucose monitoring (CGM) and automatically send commands to one Omnipod for insulin and one Omnipod for pramlintide delivery.

Interventions

  • MPC closed-loop system in insulin only modeDevice
  • MPC closed-loop system in insulin/pramlintide modeDevice

Arms2

  • Experimental

    Insulin Only Arm

    Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.

  • Experimental

    Insulin and Pramlintide Arm

    Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Incremental Area Under the Curve of Postprandial Glucose Following the First Meal

    Time frame · 6 hours following first meal

    Registry description

    Incremental area under the curve (iAUC) of postprandial glucose (mg/dL\*min) calculated using a trapezoidal method, which sums all continuous glucose monitoring (CGM) values above the starting glucose for the obseration period. Values shown are (mg/dL\*min)/1000.

  2. Percent of Time With Sensed Glucose Between 70 - 180 mg/dl Following First Meal

    Time frame · 6 hours following first meal

    Registry description

    Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. Percent of time in range can take values between 0 and 100 and uses the six hours following the meal as the denominator.

Secondary outcomes(20)

  1. Incremental Area Under the Curve of Postprandial Glucose Following the Second Meal

    Time frame · 6 hours following second meal

    Registry description

    Incremental area under the curve (iAUC) of postprandial glucose (mg/dL\*min) calculated using a trapezoidal method, which sums all continuous glucose monitoring (CGM) values above the starting glucose for the obseration period. Values shown are iAUC/1000.

  2. Percent of Time With Sensed Glucose Between 70 - 180 mg/dl Following Second Meal

    Time frame · 6 hours following second meal

    Registry description

    Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. Percent of time in range can take values between 0 and 100 and uses the six hours following the meal as the denominator.

  3. Net Area Under the Curve of Postprandial Glucose Following the First Meal

    Time frame · 6 hours following first meal

    Registry description

    Net area under the curve (netAUC) of postprandial glucose (mg/dL\*min) calculated using a trapezoidal method, which sums all continuous glucose monitoring (CGM) values above the starting glucose and subtracts CGM values below the starting glucose for the observation period. Values shown are (mg/dL\*min)/1000.

  4. Net Area Under the Curve of Postprandial Glucose Following the Second Meal

    Time frame · 6 hours following second meal

    Registry description

    Net area under the curve (netAUC) of postprandial glucose (mg/dL\*min) calculated using a trapezoidal method, which sums all continuous glucose monitoring (CGM) values above the starting glucose and subtracts CGM values below the starting glucose for the observation period. Values shown are (mg/dl \*min)/1000

  5. Net Area Under the Curve of Postprandial Glucose

    Time frame · 12 hour clinic visit

    Registry description

    Net area under the curve (netAUC) of postprandial glucose (mg/dL\*min) calculated using a trapezoidal method, which sums all continuous glucose monitoring (CGM) values above the starting glucose and subtracts CGM values below the starting glucose for the observation period. Values shown are (mg/dL\*min)/1000.

  6. Percent of Time With Sensed Glucose <70 mg/dL Following First Meal

    Time frame · 6 hours following first meal

    Registry description

    Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 70 mg/dl using Dexcom sensor in the 6 hours following the start of the first meal. Because so few participants had any sensed glucose values \<70 mg/dL, this summary shows the count of participants with any time (\>0) with sensed glucose \<70 mg/dL

  7. Percent of Time With Sensed Glucose <70 mg/dL Following Second Meal

    Time frame · 6 hours following second meal

    Registry description

    Because so few participants had any sensed glucose values \<70 mg/dL, this summary shows the count of participants with any time (\>0) with sensed glucose \<70 mg/dL

  8. Percent of Time With Sensed Glucose <70 mg/dL

    Time frame · 12 hour clinic visit

    Registry description

    Because so few participants had any sensed glucose values \<70 mg/dL, this summary shows the count of participants with any time (\>0) with sensed glucose \<70 mg/dL

  9. Percent of Time With Sensed Glucose Between 70-140 mg/dL Following First Meal

    Time frame · 6 hours following first meal

    Registry description

    Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. Percent of time in range can take values between 0 and 100 and uses the six hours following the meal as the denominator.

  10. Percent of Time With Sensed Glucose Between 70-140 mg/dL Following Second Meal

    Time frame · 6 hours following second meal

    Registry description

    Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. Percent of time in range can take values between 0 and 100 and uses the six hours following the meal as the denominator.

  11. Percent of Time With Sensed Glucose Between 70-140 mg/dL

    Time frame · 12 hour clinic visit

    Registry description

    Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. Percent of time in range can take values between 0 and 100 and uses the twelve hours of the clinic visit as the denominator.

  12. Mean Sensed Glucose Following First Meal

    Time frame · 6 hours following first meal

    Registry description

    Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. The outcome is calculated as the average of these values for the six hours following the meal.

  13. Mean Sensed Glucose Following Second Meal

    Time frame · 6 hours following second meal

    Registry description

    Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. The outcome is calculated as the average of these values for the six hours following the meal.

  14. Mean Sensed Glucose

    Time frame · 12 hour clinic visit

    Registry description

    Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. The outcome is calculated as the average of these values for the twelve-hour clinic visit.

  15. Percent of Time With Sensed Glucose <54 mg/dL Following First Meal

    Time frame · 6 hours following first meal

    Registry description

    Because so few participants had any sensed glucose values \<54 mg/dL, this summary shows the count of participants with any time (\>0) with sensed glucose \<54 mg/dL

  16. Percent of Time With Sensed Glucose <54 mg/dL Following Second Meal

    Time frame · 6 hours following second meal

    Registry description

    Because so few participants had any sensed glucose values \<54 mg/dL, this summary shows the count of participants with any time (\>0) with sensed glucose \<54 mg/dL

  17. Percent of Time With Sensed Glucose <54 mg/dL

    Time frame · 12 hour clinic visit

    Registry description

    Because so few participants had any sensed glucose values \<54 mg/dL, this summary shows the count of participants with any time (\>0) with sensed glucose \<54 mg/dL.

  18. Percent of Time With Sensed Glucose >180 mg/dL Following First Meal

    Time frame · 6 hours following first meal

    Registry description

    Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. Percent of time in range can take values between 0 and 100 and uses the six hours following the meal as the denominator.

  19. Percent of Time With Sensed Glucose >180 mg/dL Following Second Meal

    Time frame · 6 hours following second meal

    Registry description

    Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. Percent of time in range can take values between 0 and 100 and uses the six hours following the meal as the denominator.

  20. Percent of Time With Sensed Glucose >180 mg/dL

    Time frame · 12 hour clinic visit

    Registry description

    Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. Percent of time in range can take values between 0 and 100 and uses the twelve-hour clinic visit as the denominator.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 6 hours following first meal

Incremental Area Under the Curve of Postprandial Glucose Following the First Meal

GroupValue ((mg/dl*min)/1000)Spread
Insulin and Pramlintide Arm18.113.6
Insulin Only Arm20.913.0
Primary outcomeMean· 6 hours following first meal

Percent of Time With Sensed Glucose Between 70 - 180 mg/dl Following First Meal

GroupValue (Percent time in range)Spread
Insulin and Pramlintide Arm50.529.5
Insulin Only Arm44.323.6
Secondary and other outcome results(6)
Secondary outcomeMean· 6 hours following second meal

Incremental Area Under the Curve of Postprandial Glucose Following the Second Meal

GroupValue ((mg/dl*min)/1000)Spread
Insulin and Pramlintide Arm11.09.8
Insulin Only Arm23.412.1
Secondary outcomeMean· 6 hours following second meal

Percent of Time With Sensed Glucose Between 70 - 180 mg/dl Following Second Meal

GroupValue (Percent time in range)Spread
Insulin and Pramlintide Arm74.424.1
Insulin Only Arm49.320.1
Secondary outcomeMean· 6 hours following first meal

Net Area Under the Curve of Postprandial Glucose Following the First Meal

GroupValue ((mg/dL*min)/1000)Spread
Insulin and Pramlintide Arm14.916.6
Insulin Only Arm15.018.1
Secondary outcomeMean· 6 hours following second meal

Net Area Under the Curve of Postprandial Glucose Following the Second Meal

GroupValue ((mg/dl *min)/1000)Spread
Insulin and Pramlintide Arm6.414.4
Insulin Only Arm22.213.3
Secondary outcomeMean· 12 hour clinic visit

Net Area Under the Curve of Postprandial Glucose

GroupValue ((mg/dL*min)/1000)Spread
Insulin and Pramlintide Arm6.614.2
Insulin Only Arm22.213.3
Secondary outcomeCount of participants· 6 hours following first meal

Percent of Time With Sensed Glucose <70 mg/dL Following First Meal

GroupValue (Participants)Spread
Insulin and Pramlintide Arm52.4
Insulin Only Arm62.5

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Insulin Only ArmParticipants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.0 / 310 / 3117 / 31
Insulin and Pramlintide ArmParticipants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.0 / 310 / 310 / 31

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Diagnosis of type 1 diabetes mellitus for at least 1 year. * Participants 18 to 70 years of age. * Current use of an insulin pump for at least 3 months with stable insulin pump settings for \>2 weeks OR current use of multiple day injection insulin therapy with stable doses for \>2 weeks. * Uses a carbohydrate ratio, at lease occasionally, to dose meal time insulin. * HbA1c ≤ 10.5% at screening. * Total daily insulin requirement is less than 139 units/day. * Willingness to follow all study procedures, including attending all clinic visits. * Willingness to sign informed consent and HIPAA documents. Exclusion Criteria: * Individual of childbearing potential who is pregnant or intending to become pregnant or breast-feeding, or is not using adequate contraceptive methods. Acceptable contraception includes birth control pill / patch / vaginal ring, Depo-Provera, Norplant, an IUD, the double barrier method (the woman uses a diaphragm and spermicide and the man uses a condom), or abstinence. * Any cardiovascular disease, defined as a clinically significant EKG abnormality at the time of screening or any history of: stroke, heart failure, myocardial infarction, angina pectoris, or coronary arterial bypass graft or angioplasty. Diagnosis of 2nd or 3rd degree heart block or any non-physiological arrhythmia judged by the investigator to be exclusionary. * Renal insufficiency (GFR \< 60 ml/min, using the MDRD equation as reported by the OHSU laboratory). * Liver failure, cirrhosis, or any other liver disease that compromises liver function as determined by the investigator. * History of severe hypoglycemia during the past 3 months prior to screening visit or hypoglycemia unawareness as judged by the investigator. Participants will complete a hypoglycemia awareness questionnaire. Participants will be excluded for four or more R responses. * History of diabetes ketoacidosis during the prior 3 months prior to screening visit, as diagnosed on hospital admission or as judged by the investigator. * Adrenal insufficiency. * Any active infection requiring treatment (example soft tissue infection requiring antibiotics). * Known or suspected abuse of alcohol, narcotics, or illicit drugs. * Seizure disorder. * Active foot ulceration. * Major surgical operation within 30 days prior to screening. * Use of an investigational drug within 30 days prior to screening. * Chronic usage of any immunosuppressive medication (such as cyclosporine, azathioprine, sirolimus, or tacrolimus). * Bleeding disorder, treatment with warfarin, or platelet count below 50,000. * Allergy to aspart insulin. * Allergy to pramlintide. * Current administration of oral or parenteral corticosteroids. * Any life-threatening disease, including malignant neoplasms and medical history of malignant neoplasms within the past 5 years prior to screening (except basal and squamous cell skin cancer). * Current use of any medication intended to lower glucose other than insulin or pramlintide (ex. use of liraglutide, metformin). * Gastroparesis * Diets consisting of less than 50 grams of carbohydrates per day. * Dietary restrictions or allergies to the study meals * Any clinically significant disease or disorder which in the opinion of the Investigator may jeopardize the participant's safety or compliance with the protocol.

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