Trial Outcomes & Findings for Two Way Crossover Closed Loop MPC vs Control IQ (NCT NCT05799781)
NCT ID: NCT05799781
Last Updated: 2026-03-06
Results Overview
Assess the percent of time that the Dexcom G6 reported sensor glucose values between 70-180 mg/dl using Dexcom sensor across both arms.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
29 participants
Primary outcome timeframe
7 days in each treatment arm
Results posted on
2026-03-06
Participant Flow
42 people were screened between March of 2023 to December of 2024 at hospital associated specialty clinic in Oregon Health and Science University and University of Washington with 13 people that did not meet screening criteria.
Participant milestones
| Measure |
MPC to Control
Participants used the MPC closed-loop system for 7 days using Fiasp insulin. They spent first 6 hours in clinic being trained on the system, then eating a meal. Then the participant took the system home to continue using for 7 days. After the 7 days were complete, the participant was returned to their usual care insulin regimen and study supplies were returned.
|
Control to MPC
Participants continued their normal diabetes regimen which includes their usual care automated insulin delivery system with Dexcom G6 CGM for 7 days. Participants shared their pump download and Dexcom Clarity data with study staff after the 7 days was complete.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
15
|
|
Overall Study
COMPLETED
|
12
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
2 enrolled participants withdrew from the study due to scheduling conflicts; 1 participant was withdrawn due to diagnosis of DKA after randomization but before completing any study procedures and 1 participant was withdrawn due to an unrelated adverse event (viral infection) after randomization but before completing any study procedures.
Baseline characteristics by cohort
| Measure |
MPC to Control
n=12 Participants
Participants used the MPC closed-loop system for 7 days using Fiasp insulin. They spent first 6 hours in clinic being trained on the system, then eating a meal. Then the participant took the system home to continue using for 7 days. After the 7 days were complete, the participant was returned to their usual care insulin regimen and study supplies were returned.
|
Control to MPC
n=13 Participants
Participants continued their normal diabetes regimen which includes their usual care automated insulin delivery system with Dexcom G6 CGM for 7 days. Participants shared their pump download and Dexcom Clarity data with study staff after the 7 days was complete.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Female
|
6 Participants
n=41 Participants • 2 enrolled participants withdrew from the study due to scheduling conflicts; 1 participant was withdrawn due to diagnosis of DKA after randomization but before completing any study procedures and 1 participant was withdrawn due to an unrelated adverse event (viral infection) after randomization but before completing any study procedures.
|
7 Participants
n=35 Participants • 2 enrolled participants withdrew from the study due to scheduling conflicts; 1 participant was withdrawn due to diagnosis of DKA after randomization but before completing any study procedures and 1 participant was withdrawn due to an unrelated adverse event (viral infection) after randomization but before completing any study procedures.
|
13 Participants
n=76 Participants • 2 enrolled participants withdrew from the study due to scheduling conflicts; 1 participant was withdrawn due to diagnosis of DKA after randomization but before completing any study procedures and 1 participant was withdrawn due to an unrelated adverse event (viral infection) after randomization but before completing any study procedures.
|
|
Sex: Female, Male
Male
|
6 Participants
n=41 Participants • 2 enrolled participants withdrew from the study due to scheduling conflicts; 1 participant was withdrawn due to diagnosis of DKA after randomization but before completing any study procedures and 1 participant was withdrawn due to an unrelated adverse event (viral infection) after randomization but before completing any study procedures.
|
6 Participants
n=35 Participants • 2 enrolled participants withdrew from the study due to scheduling conflicts; 1 participant was withdrawn due to diagnosis of DKA after randomization but before completing any study procedures and 1 participant was withdrawn due to an unrelated adverse event (viral infection) after randomization but before completing any study procedures.
|
12 Participants
n=76 Participants • 2 enrolled participants withdrew from the study due to scheduling conflicts; 1 participant was withdrawn due to diagnosis of DKA after randomization but before completing any study procedures and 1 participant was withdrawn due to an unrelated adverse event (viral infection) after randomization but before completing any study procedures.
|
|
Age, Continuous
|
34.3 Years
STANDARD_DEVIATION 11.0 • n=41 Participants • 2 enrolled participants withdrew from the study due to scheduling conflicts; 1 participant was withdrawn due to diagnosis of DKA after randomization but before completing any study procedures and 1 participant was withdrawn due to an unrelated adverse event (viral infection) after randomization but before completing any study procedures.
|
28.9 Years
STANDARD_DEVIATION 8.4 • n=35 Participants • 2 enrolled participants withdrew from the study due to scheduling conflicts; 1 participant was withdrawn due to diagnosis of DKA after randomization but before completing any study procedures and 1 participant was withdrawn due to an unrelated adverse event (viral infection) after randomization but before completing any study procedures.
|
31.5 Years
STANDARD_DEVIATION 9.9 • n=76 Participants • 2 enrolled participants withdrew from the study due to scheduling conflicts; 1 participant was withdrawn due to diagnosis of DKA after randomization but before completing any study procedures and 1 participant was withdrawn due to an unrelated adverse event (viral infection) after randomization but before completing any study procedures.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants • 2 enrolled participants withdrew from the study due to scheduling conflicts; 1 participant was withdrawn due to diagnosis of DKA after randomization but before completing any study procedures and 1 participant was withdrawn due to an unrelated adverse event (viral infection) after randomization but before completing any study procedures.
|
2 Participants
n=35 Participants • 2 enrolled participants withdrew from the study due to scheduling conflicts; 1 participant was withdrawn due to diagnosis of DKA after randomization but before completing any study procedures and 1 participant was withdrawn due to an unrelated adverse event (viral infection) after randomization but before completing any study procedures.
|
2 Participants
n=76 Participants • 2 enrolled participants withdrew from the study due to scheduling conflicts; 1 participant was withdrawn due to diagnosis of DKA after randomization but before completing any study procedures and 1 participant was withdrawn due to an unrelated adverse event (viral infection) after randomization but before completing any study procedures.
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants • 2 enrolled participants withdrew from the study due to scheduling conflicts; 1 participant was withdrawn due to diagnosis of DKA after randomization but before completing any study procedures and 1 participant was withdrawn due to an unrelated adverse event (viral infection) after randomization but before completing any study procedures.
|
0 Participants
n=35 Participants • 2 enrolled participants withdrew from the study due to scheduling conflicts; 1 participant was withdrawn due to diagnosis of DKA after randomization but before completing any study procedures and 1 participant was withdrawn due to an unrelated adverse event (viral infection) after randomization but before completing any study procedures.
|
0 Participants
n=76 Participants • 2 enrolled participants withdrew from the study due to scheduling conflicts; 1 participant was withdrawn due to diagnosis of DKA after randomization but before completing any study procedures and 1 participant was withdrawn due to an unrelated adverse event (viral infection) after randomization but before completing any study procedures.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants • 2 enrolled participants withdrew from the study due to scheduling conflicts; 1 participant was withdrawn due to diagnosis of DKA after randomization but before completing any study procedures and 1 participant was withdrawn due to an unrelated adverse event (viral infection) after randomization but before completing any study procedures.
|
0 Participants
n=35 Participants • 2 enrolled participants withdrew from the study due to scheduling conflicts; 1 participant was withdrawn due to diagnosis of DKA after randomization but before completing any study procedures and 1 participant was withdrawn due to an unrelated adverse event (viral infection) after randomization but before completing any study procedures.
|
0 Participants
n=76 Participants • 2 enrolled participants withdrew from the study due to scheduling conflicts; 1 participant was withdrawn due to diagnosis of DKA after randomization but before completing any study procedures and 1 participant was withdrawn due to an unrelated adverse event (viral infection) after randomization but before completing any study procedures.
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=41 Participants • 2 enrolled participants withdrew from the study due to scheduling conflicts; 1 participant was withdrawn due to diagnosis of DKA after randomization but before completing any study procedures and 1 participant was withdrawn due to an unrelated adverse event (viral infection) after randomization but before completing any study procedures.
|
1 Participants
n=35 Participants • 2 enrolled participants withdrew from the study due to scheduling conflicts; 1 participant was withdrawn due to diagnosis of DKA after randomization but before completing any study procedures and 1 participant was withdrawn due to an unrelated adverse event (viral infection) after randomization but before completing any study procedures.
|
2 Participants
n=76 Participants • 2 enrolled participants withdrew from the study due to scheduling conflicts; 1 participant was withdrawn due to diagnosis of DKA after randomization but before completing any study procedures and 1 participant was withdrawn due to an unrelated adverse event (viral infection) after randomization but before completing any study procedures.
|
|
Race (NIH/OMB)
White
|
11 Participants
n=41 Participants • 2 enrolled participants withdrew from the study due to scheduling conflicts; 1 participant was withdrawn due to diagnosis of DKA after randomization but before completing any study procedures and 1 participant was withdrawn due to an unrelated adverse event (viral infection) after randomization but before completing any study procedures.
|
10 Participants
n=35 Participants • 2 enrolled participants withdrew from the study due to scheduling conflicts; 1 participant was withdrawn due to diagnosis of DKA after randomization but before completing any study procedures and 1 participant was withdrawn due to an unrelated adverse event (viral infection) after randomization but before completing any study procedures.
|
21 Participants
n=76 Participants • 2 enrolled participants withdrew from the study due to scheduling conflicts; 1 participant was withdrawn due to diagnosis of DKA after randomization but before completing any study procedures and 1 participant was withdrawn due to an unrelated adverse event (viral infection) after randomization but before completing any study procedures.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants • 2 enrolled participants withdrew from the study due to scheduling conflicts; 1 participant was withdrawn due to diagnosis of DKA after randomization but before completing any study procedures and 1 participant was withdrawn due to an unrelated adverse event (viral infection) after randomization but before completing any study procedures.
|
0 Participants
n=35 Participants • 2 enrolled participants withdrew from the study due to scheduling conflicts; 1 participant was withdrawn due to diagnosis of DKA after randomization but before completing any study procedures and 1 participant was withdrawn due to an unrelated adverse event (viral infection) after randomization but before completing any study procedures.
|
0 Participants
n=76 Participants • 2 enrolled participants withdrew from the study due to scheduling conflicts; 1 participant was withdrawn due to diagnosis of DKA after randomization but before completing any study procedures and 1 participant was withdrawn due to an unrelated adverse event (viral infection) after randomization but before completing any study procedures.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants • 2 enrolled participants withdrew from the study due to scheduling conflicts; 1 participant was withdrawn due to diagnosis of DKA after randomization but before completing any study procedures and 1 participant was withdrawn due to an unrelated adverse event (viral infection) after randomization but before completing any study procedures.
|
0 Participants
n=35 Participants • 2 enrolled participants withdrew from the study due to scheduling conflicts; 1 participant was withdrawn due to diagnosis of DKA after randomization but before completing any study procedures and 1 participant was withdrawn due to an unrelated adverse event (viral infection) after randomization but before completing any study procedures.
|
0 Participants
n=76 Participants • 2 enrolled participants withdrew from the study due to scheduling conflicts; 1 participant was withdrawn due to diagnosis of DKA after randomization but before completing any study procedures and 1 participant was withdrawn due to an unrelated adverse event (viral infection) after randomization but before completing any study procedures.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=41 Participants • 2 enrolled participants withdrew from the study due to scheduling conflicts; 1 participant was withdrawn due to diagnosis of DKA after randomization but before completing any study procedures and 1 participant was withdrawn due to an unrelated adverse event (viral infection) after randomization but before completing any study procedures.
|
2 Participants
n=35 Participants • 2 enrolled participants withdrew from the study due to scheduling conflicts; 1 participant was withdrawn due to diagnosis of DKA after randomization but before completing any study procedures and 1 participant was withdrawn due to an unrelated adverse event (viral infection) after randomization but before completing any study procedures.
|
4 Participants
n=76 Participants • 2 enrolled participants withdrew from the study due to scheduling conflicts; 1 participant was withdrawn due to diagnosis of DKA after randomization but before completing any study procedures and 1 participant was withdrawn due to an unrelated adverse event (viral infection) after randomization but before completing any study procedures.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=41 Participants • 2 enrolled participants withdrew from the study due to scheduling conflicts; 1 participant was withdrawn due to diagnosis of DKA after randomization but before completing any study procedures and 1 participant was withdrawn due to an unrelated adverse event (viral infection) after randomization but before completing any study procedures.
|
11 Participants
n=35 Participants • 2 enrolled participants withdrew from the study due to scheduling conflicts; 1 participant was withdrawn due to diagnosis of DKA after randomization but before completing any study procedures and 1 participant was withdrawn due to an unrelated adverse event (viral infection) after randomization but before completing any study procedures.
|
21 Participants
n=76 Participants • 2 enrolled participants withdrew from the study due to scheduling conflicts; 1 participant was withdrawn due to diagnosis of DKA after randomization but before completing any study procedures and 1 participant was withdrawn due to an unrelated adverse event (viral infection) after randomization but before completing any study procedures.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants • 2 enrolled participants withdrew from the study due to scheduling conflicts; 1 participant was withdrawn due to diagnosis of DKA after randomization but before completing any study procedures and 1 participant was withdrawn due to an unrelated adverse event (viral infection) after randomization but before completing any study procedures.
|
0 Participants
n=35 Participants • 2 enrolled participants withdrew from the study due to scheduling conflicts; 1 participant was withdrawn due to diagnosis of DKA after randomization but before completing any study procedures and 1 participant was withdrawn due to an unrelated adverse event (viral infection) after randomization but before completing any study procedures.
|
0 Participants
n=76 Participants • 2 enrolled participants withdrew from the study due to scheduling conflicts; 1 participant was withdrawn due to diagnosis of DKA after randomization but before completing any study procedures and 1 participant was withdrawn due to an unrelated adverse event (viral infection) after randomization but before completing any study procedures.
|
|
Weight (kg)
|
89.9 kg
STANDARD_DEVIATION 17.6 • n=41 Participants • 2 enrolled participants withdrew from the study due to scheduling conflicts; 1 participant was withdrawn due to diagnosis of DKA after randomization but before completing any study procedures and 1 participant was withdrawn due to an unrelated adverse event (viral infection) after randomization but before completing any study procedures.
|
85.0 kg
STANDARD_DEVIATION 14.1 • n=35 Participants • 2 enrolled participants withdrew from the study due to scheduling conflicts; 1 participant was withdrawn due to diagnosis of DKA after randomization but before completing any study procedures and 1 participant was withdrawn due to an unrelated adverse event (viral infection) after randomization but before completing any study procedures.
|
87.4 kg
STANDARD_DEVIATION 15.7 • n=76 Participants • 2 enrolled participants withdrew from the study due to scheduling conflicts; 1 participant was withdrawn due to diagnosis of DKA after randomization but before completing any study procedures and 1 participant was withdrawn due to an unrelated adverse event (viral infection) after randomization but before completing any study procedures.
|
PRIMARY outcome
Timeframe: 7 days in each treatment armPopulation: 2 enrolled participants were withdrawn from the study due to scheduling conflicts; 1 participant was withdrawn due to diagnosis of DKA after randomization but before completing any study procedures and 1 participant was withdrawn due to an unrelated adverse event (viral infection) after randomization but before completing any study procedures.
Assess the percent of time that the Dexcom G6 reported sensor glucose values between 70-180 mg/dl using Dexcom sensor across both arms.
Outcome measures
| Measure |
MPC Intervention
n=25 Participants
Participants will use the MPC closed-loop system for 7 days using Fiasp insulin. The first 6 hours will be spent in clinic being trained on the system, then eating a meal. Then the participant will take the system home to continue using for 7 days.
|
Control
n=25 Participants
Participants will continue their normal diabetes regimen which includes the t:slim X2 pump with Dexcom G6 CGM and Control IQ for 7 days. Participants will share their pump download and Dexcom Clarity data with study staff after the 7 days is complete.
|
|---|---|---|
|
Percent of Time With Sensed Glucose Between 70-180 mg/dl
|
56 Percent (%)
Standard Deviation 12
|
56.8 Percent (%)
Standard Deviation 12.7
|
SECONDARY outcome
Timeframe: 7 days in each treatment armAssess the percent of time that the Dexcom G6 reported sensor glucose values less than 54 mg/dl using Dexcom sensor across both arms.
Outcome measures
| Measure |
MPC Intervention
n=25 Participants
Participants will use the MPC closed-loop system for 7 days using Fiasp insulin. The first 6 hours will be spent in clinic being trained on the system, then eating a meal. Then the participant will take the system home to continue using for 7 days.
|
Control
n=25 Participants
Participants will continue their normal diabetes regimen which includes the t:slim X2 pump with Dexcom G6 CGM and Control IQ for 7 days. Participants will share their pump download and Dexcom Clarity data with study staff after the 7 days is complete.
|
|---|---|---|
|
Percent of Time With Sensed Glucose < 54 mg/dl
|
0.14 Percent (%)
Standard Deviation 0.3
|
0.05 Percent (%)
Standard Deviation 0.19
|
SECONDARY outcome
Timeframe: 7 days in each treatment armPopulation: 2 enrolled participants were withdrawn from the study due to scheduling conflicts; 1 participant was withdrawn due to diagnosis of DKA after randomization but before completing any study procedures and 1 participant was withdrawn due to an unrelated adverse event (viral infection) after randomization but before completing any study procedures.
Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 70 mg/dl using Dexcom sensor across both arms.
Outcome measures
| Measure |
MPC Intervention
n=25 Participants
Participants will use the MPC closed-loop system for 7 days using Fiasp insulin. The first 6 hours will be spent in clinic being trained on the system, then eating a meal. Then the participant will take the system home to continue using for 7 days.
|
Control
n=25 Participants
Participants will continue their normal diabetes regimen which includes the t:slim X2 pump with Dexcom G6 CGM and Control IQ for 7 days. Participants will share their pump download and Dexcom Clarity data with study staff after the 7 days is complete.
|
|---|---|---|
|
Percent of Time With Sensed Glucose < 70 mg/dl
|
0.59 Percent (%)
Standard Deviation 0.69
|
0.51 Percent (%)
Standard Deviation 0.73
|
SECONDARY outcome
Timeframe: 7 days in each treatment armAssess the percent of time that the Dexcom G6 reported sensor glucose values greater than 180 mg/dl using Dexcom sensor across both arms.
Outcome measures
| Measure |
MPC Intervention
n=25 Participants
Participants will use the MPC closed-loop system for 7 days using Fiasp insulin. The first 6 hours will be spent in clinic being trained on the system, then eating a meal. Then the participant will take the system home to continue using for 7 days.
|
Control
n=25 Participants
Participants will continue their normal diabetes regimen which includes the t:slim X2 pump with Dexcom G6 CGM and Control IQ for 7 days. Participants will share their pump download and Dexcom Clarity data with study staff after the 7 days is complete.
|
|---|---|---|
|
Percent of Time With Sensed Glucose > 180 mg/dl
|
43.4 Percent (%)
Standard Deviation 12.1
|
42.7 Percent (%)
Standard Deviation 12.9
|
SECONDARY outcome
Timeframe: 7 days in each treatment armMean sensed glucose from the Dexcom G6 reported sensor glucose values. 7 days in each treatment arm: Sensed Glucose values were averaged across the 7 days for MPC Intervention and and across the 7 days for Control
Outcome measures
| Measure |
MPC Intervention
n=25 Participants
Participants will use the MPC closed-loop system for 7 days using Fiasp insulin. The first 6 hours will be spent in clinic being trained on the system, then eating a meal. Then the participant will take the system home to continue using for 7 days.
|
Control
n=25 Participants
Participants will continue their normal diabetes regimen which includes the t:slim X2 pump with Dexcom G6 CGM and Control IQ for 7 days. Participants will share their pump download and Dexcom Clarity data with study staff after the 7 days is complete.
|
|---|---|---|
|
Mean Sensed Glucose
|
182 mg/dl
Standard Deviation 19
|
181 mg/dl
Standard Deviation 24
|
SECONDARY outcome
Timeframe: 7 days in each treatment armContinuous glucose monitoring (CGM) values were recorded every five minutes and summarized for each treatment arm. Coefficient of variation was calculated as 100 \* (standard deviation) / (mean) of sensed glucose. Lower values are desirable for this outcome. This is a ratio. Thus, there are no units for this outcome.
Outcome measures
| Measure |
MPC Intervention
n=25 Participants
Participants will use the MPC closed-loop system for 7 days using Fiasp insulin. The first 6 hours will be spent in clinic being trained on the system, then eating a meal. Then the participant will take the system home to continue using for 7 days.
|
Control
n=25 Participants
Participants will continue their normal diabetes regimen which includes the t:slim X2 pump with Dexcom G6 CGM and Control IQ for 7 days. Participants will share their pump download and Dexcom Clarity data with study staff after the 7 days is complete.
|
|---|---|---|
|
Coefficient of Variation of Glucose (Unitless)
|
34.6 Unitless
Standard Deviation 5.2
|
34.7 Unitless
Standard Deviation 4.7
|
SECONDARY outcome
Timeframe: 7 days in each treatment armAccess the mean amount of insulin delivered per day by the Omnipod through the AP system study in units/kg across both arms.
Outcome measures
| Measure |
MPC Intervention
n=25 Participants
Participants will use the MPC closed-loop system for 7 days using Fiasp insulin. The first 6 hours will be spent in clinic being trained on the system, then eating a meal. Then the participant will take the system home to continue using for 7 days.
|
Control
n=25 Participants
Participants will continue their normal diabetes regimen which includes the t:slim X2 pump with Dexcom G6 CGM and Control IQ for 7 days. Participants will share their pump download and Dexcom Clarity data with study staff after the 7 days is complete.
|
|---|---|---|
|
Mean Amount of Insulin Delivered Per Day (in Units/kg)
|
0.73 Units/kg
Standard Deviation 0.34
|
0.78 Units/kg
Standard Deviation 0.37
|
Adverse Events
MPC Intervention Arm
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Control Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MPC Intervention Arm
n=25 participants at risk
Participants used the MPC closed-loop system for 7 days using Fiasp insulin. They spent first 6 hours in clinic being trained on the system, then eating a meal. Then the participant took the system home to continue using for 7 days. After the 7 days were complete, the participant was returned to their usual care insulin regimen and study supplies were returned.
|
Control Arm
n=25 participants at risk
Participants continued their normal diabetes regimen which includes their usual care automated insulin delivery system with Dexcom G6 CGM for 7 days. Participants shared their pump download and Dexcom Clarity data with study staff after the 7 days was complete.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Device site reaction
|
12.0%
3/25 • Up to 22 weeks
|
0.00%
0/25 • Up to 22 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place