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Trial Outcomes & Findings for Omnipod® 5 With Libre 2 vs. MDI for Type 1 Diabetes in Children and Adults (NCT NCT05923827)

NCT ID: NCT05923827

Last Updated: 2026-04-14

Results Overview

The change in HbA1c at 13 weeks from baseline between the Intervention and Control groups.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

189 participants

Primary outcome timeframe

Comparing intervention group with control group during the 13-week study phase

Results posted on

2026-04-14

Participant Flow

A total of 189 participants were enrolled; however, one participant was withdrawn prior to randomization, resulting in 188 participants started and assigned to study arms - 125 for intervention and 63 for control.

Participant milestones

Participant milestones
Measure
Intervention Group
Omnipod 5 System with FreeStyle Libre 2 continuous glucose monitor Omnipod 5 System: The Omnipod 5 system is a tubeless patch pump that receives glucose values and trend data from the glucose sensor every 5 minutes, automatically calculates insulin dose, and sends delivery commands to the Pod for the delivery of insulin.
Control Group
Multiple daily injections of insulin with FreeStyle Libre 2 continuous glucose monitor
Overall Study
STARTED
125
63
Overall Study
COMPLETED
124
63
Overall Study
NOT COMPLETED
1
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Intervention Group
Omnipod 5 System with FreeStyle Libre 2 continuous glucose monitor Omnipod 5 System: The Omnipod 5 system is a tubeless patch pump that receives glucose values and trend data from the glucose sensor every 5 minutes, automatically calculates insulin dose, and sends delivery commands to the Pod for the delivery of insulin.
Control Group
Multiple daily injections of insulin with FreeStyle Libre 2 continuous glucose monitor
Overall Study
Withdrawal by Subject
1
0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Intervention Group
n=125 Participants
Omnipod 5 System with FreeStyle Libre 2 continuous glucose monitor Omnipod 5 System: The Omnipod 5 system is a tubeless patch pump that receives glucose values and trend data from the glucose sensor every 5 minutes, automatically calculates insulin dose, and sends delivery commands to the Pod for the delivery of insulin.
Control Group
n=63 Participants
Multiple daily injections of insulin with FreeStyle Libre 2 continuous glucose monitor
Total
n=188 Participants
Total of all reporting groups
Age, Continuous
24 years
STANDARD_DEVIATION 16 • n=125 Participants
24 years
STANDARD_DEVIATION 18 • n=63 Participants
24 years
STANDARD_DEVIATION 17 • n=188 Participants
Sex: Female, Male
Female
54 Participants
n=125 Participants
32 Participants
n=63 Participants
86 Participants
n=188 Participants
Sex: Female, Male
Male
71 Participants
n=125 Participants
31 Participants
n=63 Participants
102 Participants
n=188 Participants
Race and Ethnicity Not Collected
—
—
0 Participants
Race and Ethnicity were not collected from any participant.
Region of Enrollment
Belgium
8 participants
n=125 Participants
3 participants
n=63 Participants
11 participants
n=188 Participants
Region of Enrollment
United Kingdom
24 participants
n=125 Participants
13 participants
n=63 Participants
37 participants
n=188 Participants
Region of Enrollment
France
93 participants
n=125 Participants
47 participants
n=63 Participants
140 participants
n=188 Participants
Height (cm)
163 cm
STANDARD_DEVIATION 16 • n=125 Participants
159 cm
STANDARD_DEVIATION 16 • n=63 Participants
162 cm
STANDARD_DEVIATION 16 • n=188 Participants
Weight (kg)
63 kg
STANDARD_DEVIATION 21 • n=125 Participants
59 kg
STANDARD_DEVIATION 21 • n=63 Participants
62 kg
STANDARD_DEVIATION 21 • n=188 Participants
BMI (kg/m^2)
23 kg/m^2
STANDARD_DEVIATION 5 • n=125 Participants
22 kg/m^2
STANDARD_DEVIATION 6 • n=63 Participants
23 kg/m^2
STANDARD_DEVIATION 5 • n=188 Participants
POC A1C (%)
8.3 percentage of A1C
STANDARD_DEVIATION 0.7 • n=125 Participants
8.2 percentage of A1C
STANDARD_DEVIATION 0.5 • n=63 Participants
8.3 percentage of A1C
STANDARD_DEVIATION 0.7 • n=188 Participants
Duration of Type I Diagnosis
11 years
STANDARD_DEVIATION 11 • n=125 Participants
11 years
STANDARD_DEVIATION 10 • n=63 Participants
11 years
STANDARD_DEVIATION 10 • n=188 Participants
Has the subject used an insulin pump in the 6 months before study? (n/N (%))
Yes
0 Participants
n=125 Participants
0 Participants
n=63 Participants
0 Participants
n=188 Participants
Has the subject used an insulin pump in the 6 months before study? (n/N (%))
No
125 Participants
n=125 Participants
63 Participants
n=63 Participants
188 Participants
n=188 Participants
Brands of Insulin currently being used by the subject - Rapid Acting Insulin
Aspart (NovoLog/NovoRapid)
59 Participants
n=125 Participants
29 Participants
n=63 Participants
88 Participants
n=188 Participants
Brands of Insulin currently being used by the subject - Rapid Acting Insulin
Aspart (Fiasp)
26 Participants
n=125 Participants
19 Participants
n=63 Participants
45 Participants
n=188 Participants
Brands of Insulin currently being used by the subject - Rapid Acting Insulin
Glulisine (Apidra)
1 Participants
n=125 Participants
0 Participants
n=63 Participants
1 Participants
n=188 Participants
Brands of Insulin currently being used by the subject - Rapid Acting Insulin
Lispro (Humalog)
31 Participants
n=125 Participants
11 Participants
n=63 Participants
42 Participants
n=188 Participants
Brands of Insulin currently being used by the subject - Rapid Acting Insulin
Lispro-aabc (Lyumjev)
6 Participants
n=125 Participants
4 Participants
n=63 Participants
10 Participants
n=188 Participants
Brands of Insulin currently being used by the subject - Rapid Acting Insulin
Aspart (NovoLog/NovoRapid) and Lispro-aabc (Lyumjev)
1 Participants
n=125 Participants
0 Participants
n=63 Participants
1 Participants
n=188 Participants
Brands of Insulin currently being used by the subject - Rapid Acting Insulin
Aspart (NovoLog/NovoRapid) and Aspart (Fiasp)
1 Participants
n=125 Participants
0 Participants
n=63 Participants
1 Participants
n=188 Participants
Brands of Insulin currently being used by the subject - Rapid Acting Insulin
None
0 Participants
n=125 Participants
0 Participants
n=63 Participants
0 Participants
n=188 Participants
Brands of Insulin currently being used by the subject - Long Acting Insulin
Degludec (Tresiba)
84 Participants
n=125 Participants
41 Participants
n=63 Participants
125 Participants
n=188 Participants
Brands of Insulin currently being used by the subject - Long Acting Insulin
Detemir (Levemir)
4 Participants
n=125 Participants
5 Participants
n=63 Participants
9 Participants
n=188 Participants
Brands of Insulin currently being used by the subject - Long Acting Insulin
Glargine (Abasaglar/Lantus/Toujeo)
37 Participants
n=125 Participants
17 Participants
n=63 Participants
54 Participants
n=188 Participants
Brands of Insulin currently being used by the subject - Long Acting Insulin
None
0 Participants
n=125 Participants
0 Participants
n=63 Participants
0 Participants
n=188 Participants
Systolic Blood Pressure (mmHg)
121 mmHg
STANDARD_DEVIATION 16 • n=125 Participants
120 mmHg
STANDARD_DEVIATION 13 • n=63 Participants
120 mmHg
STANDARD_DEVIATION 15 • n=188 Participants
Heart Rate (bpm)
80 bpm
STANDARD_DEVIATION 14 • n=125 Participants
79 bpm
STANDARD_DEVIATION 14 • n=63 Participants
80 bpm
STANDARD_DEVIATION 14 • n=188 Participants
Diastolic Blood Pressure (mmHg)
73 mmHg
STANDARD_DEVIATION 11 • n=125 Participants
75 mmHg
STANDARD_DEVIATION 10 • n=63 Participants
73 mmHg
STANDARD_DEVIATION 10 • n=188 Participants
Respiratory Rate (bpm)
18 bpm
STANDARD_DEVIATION 4 • n=125 Participants
18 bpm
STANDARD_DEVIATION 4 • n=63 Participants
18 bpm
STANDARD_DEVIATION 4 • n=188 Participants
Temperature (C°)
36.5 C°
STANDARD_DEVIATION 0.4 • n=125 Participants
36.6 C°
STANDARD_DEVIATION 0.6 • n=63 Participants
36.5 C°
STANDARD_DEVIATION 0.5 • n=188 Participants

PRIMARY outcome

Timeframe: Comparing intervention group with control group during the 13-week study phase

Population: Subjects are included in the Primary Endpoint Analysis even if data for one period is missing.

The change in HbA1c at 13 weeks from baseline between the Intervention and Control groups.

Outcome measures

Outcome measures
Measure
Intervention Group
n=125 Participants
Omnipod 5 System with FreeStyle Libre 2 continuous glucose monitor Omnipod 5 System: The Omnipod 5 system is a tubeless patch pump that receives glucose values and trend data from the glucose sensor every 5 minutes, automatically calculates insulin dose, and sends delivery commands to the Pod for the delivery of insulin.
Control Group
n=63 Participants
Multiple daily injections of insulin with FreeStyle Libre 2 continuous glucose monitor
Change in HbA1c (%)
Baseline
8.13 Percentage of HbA1C
Standard Deviation 0.70
8.10 Percentage of HbA1C
Standard Deviation 0.59
Change in HbA1c (%)
13 Weeks
7.20 Percentage of HbA1C
Standard Deviation 0.60
8.00 Percentage of HbA1C
Standard Deviation 0.73

SECONDARY outcome

Timeframe: Comparing intervention group with control group during the 13-week study phase

Population: Subjects are included in the Secondary Endpoint Analysis even if data for one period is missing.

Glucose metric from study provided continuous glucose monitor (CGM)

Outcome measures

Outcome measures
Measure
Intervention Group
n=125 Participants
Omnipod 5 System with FreeStyle Libre 2 continuous glucose monitor Omnipod 5 System: The Omnipod 5 system is a tubeless patch pump that receives glucose values and trend data from the glucose sensor every 5 minutes, automatically calculates insulin dose, and sends delivery commands to the Pod for the delivery of insulin.
Control Group
n=63 Participants
Multiple daily injections of insulin with FreeStyle Libre 2 continuous glucose monitor
Percentage of Time in Range 70-180 mg/dL
Baseline
39.42 Percentage of time
Standard Deviation 11.75
40.85 Percentage of time
Standard Deviation 13.16
Percentage of Time in Range 70-180 mg/dL
13 Weeks
65.26 Percentage of time
Standard Deviation 7.56
43.01 Percentage of time
Standard Deviation 10.99

SECONDARY outcome

Timeframe: Comparing intervention group with control group at the end of the 13-week study phase

Population: Subjects are included in the Secondary Endpoint Analysis even if data for one period is missing.

Glucose metric from CGM

Outcome measures

Outcome measures
Measure
Intervention Group
n=125 Participants
Omnipod 5 System with FreeStyle Libre 2 continuous glucose monitor Omnipod 5 System: The Omnipod 5 system is a tubeless patch pump that receives glucose values and trend data from the glucose sensor every 5 minutes, automatically calculates insulin dose, and sends delivery commands to the Pod for the delivery of insulin.
Control Group
n=63 Participants
Multiple daily injections of insulin with FreeStyle Libre 2 continuous glucose monitor
Percentage of Time <54 mg/dL (Non-inferior)
Baseline
0.61 Percentage of time
Standard Deviation 1.49
0.95 Percentage of time
Standard Deviation 2.23
Percentage of Time <54 mg/dL (Non-inferior)
13 Weeks
0.49 Percentage of time
Standard Deviation 0.52
0.63 Percentage of time
Standard Deviation 1.03

SECONDARY outcome

Timeframe: Comparing intervention group with control group at the end of the 13-week study phase

Population: Subjects are included in the Secondary Endpoint Analysis even if data for one period is missing.

Glucose metric from CGM

Outcome measures

Outcome measures
Measure
Intervention Group
n=125 Participants
Omnipod 5 System with FreeStyle Libre 2 continuous glucose monitor Omnipod 5 System: The Omnipod 5 system is a tubeless patch pump that receives glucose values and trend data from the glucose sensor every 5 minutes, automatically calculates insulin dose, and sends delivery commands to the Pod for the delivery of insulin.
Control Group
n=63 Participants
Multiple daily injections of insulin with FreeStyle Libre 2 continuous glucose monitor
Percentage of Time >180 mg/dL
Baseline
57.14 Percentage of time
Standard Deviation 13.20
55.55 Percentage of time
Standard Deviation 14.81
Percentage of Time >180 mg/dL
13 Weeks
31.90 Percentage of time
Standard Deviation 7.85
53.49 Percentage of time
Standard Deviation 11.86

SECONDARY outcome

Timeframe: Comparing intervention group with control group at the end of the 13-week study phase

Population: Subjects are included in the Secondary Endpoint Analysis even if data for one period is missing.

Glucose metric from CGM

Outcome measures

Outcome measures
Measure
Intervention Group
n=125 Participants
Omnipod 5 System with FreeStyle Libre 2 continuous glucose monitor Omnipod 5 System: The Omnipod 5 system is a tubeless patch pump that receives glucose values and trend data from the glucose sensor every 5 minutes, automatically calculates insulin dose, and sends delivery commands to the Pod for the delivery of insulin.
Control Group
n=63 Participants
Multiple daily injections of insulin with FreeStyle Libre 2 continuous glucose monitor
Percentage of Time >300 mg/dL
Baseline
15.21 Percentage of time
Standard Deviation 9.93
13.97 Percentage of time
Standard Deviation 9.46
Percentage of Time >300 mg/dL
13 Weeks
3.50 Percentage of time
Standard Deviation 2.60
13.29 Percentage of time
Standard Deviation 9.05

SECONDARY outcome

Timeframe: Comparing intervention group with control group at the end of the 13-week study phase

Population: Subjects are included in the Secondary Endpoint Analysis even if data for one period is missing.

Glucose metric from CGM

Outcome measures

Outcome measures
Measure
Intervention Group
n=125 Participants
Omnipod 5 System with FreeStyle Libre 2 continuous glucose monitor Omnipod 5 System: The Omnipod 5 system is a tubeless patch pump that receives glucose values and trend data from the glucose sensor every 5 minutes, automatically calculates insulin dose, and sends delivery commands to the Pod for the delivery of insulin.
Control Group
n=63 Participants
Multiple daily injections of insulin with FreeStyle Libre 2 continuous glucose monitor
Percentage of Time <70 mg/dL (Non-inferior)
Baseline
3.45 Percentage of time
Standard Deviation 3.71
3.59 Percentage of time
Standard Deviation 5.38
Percentage of Time <70 mg/dL (Non-inferior)
13 Weeks
2.84 Percentage of time
Standard Deviation 1.73
3.50 Percentage of time
Standard Deviation 3.53

SECONDARY outcome

Timeframe: Comparing intervention group with control group at the end of the 13-week study phase

Population: Subjects are included in the Secondary Endpoint Analysis even if data for one period is missing.

Glucose metric from study CGM

Outcome measures

Outcome measures
Measure
Intervention Group
n=52 Participants
Omnipod 5 System with FreeStyle Libre 2 continuous glucose monitor Omnipod 5 System: The Omnipod 5 system is a tubeless patch pump that receives glucose values and trend data from the glucose sensor every 5 minutes, automatically calculates insulin dose, and sends delivery commands to the Pod for the delivery of insulin.
Control Group
n=27 Participants
Multiple daily injections of insulin with FreeStyle Libre 2 continuous glucose monitor
Change From Baseline in HbA1c for Participants ≥18 Years of Age at Baseline
Baseline
8.27 Percentage of HbA1C
Standard Error 0.76
8.17 Percentage of HbA1C
Standard Error 0.62
Change From Baseline in HbA1c for Participants ≥18 Years of Age at Baseline
13 Weeks
7.32 Percentage of HbA1C
Standard Error 0.57
8.09 Percentage of HbA1C
Standard Error 0.62

SECONDARY outcome

Timeframe: Comparing intervention group with control group at the end of the 13-week study phase

Population: Subjects are included in the Secondary Endpoint Analysis even if data for one period is missing.

Glucose metric from CGM

Outcome measures

Outcome measures
Measure
Intervention Group
n=73 Participants
Omnipod 5 System with FreeStyle Libre 2 continuous glucose monitor Omnipod 5 System: The Omnipod 5 system is a tubeless patch pump that receives glucose values and trend data from the glucose sensor every 5 minutes, automatically calculates insulin dose, and sends delivery commands to the Pod for the delivery of insulin.
Control Group
n=35 Participants
Multiple daily injections of insulin with FreeStyle Libre 2 continuous glucose monitor
Change From Baseline in HbA1c for Participants <18 Years of Age at Baseline
Baseline
8.02 Percentage of HbA1C
Standard Error 0.65
8.06 Percentage of HbA1C
Standard Error 0.57
Change From Baseline in HbA1c for Participants <18 Years of Age at Baseline
13 Weeks
7.11 Percentage of HbA1C
Standard Error 0.62
7.92 Percentage of HbA1C
Standard Error 0.82

SECONDARY outcome

Timeframe: Comparing intervention group with control group at the end of the 13-week study phase

Population: Subjects are included in the Secondary Endpoint Analysis even if data for one period is missing.

Glucose metric from CGM

Outcome measures

Outcome measures
Measure
Intervention Group
n=52 Participants
Omnipod 5 System with FreeStyle Libre 2 continuous glucose monitor Omnipod 5 System: The Omnipod 5 system is a tubeless patch pump that receives glucose values and trend data from the glucose sensor every 5 minutes, automatically calculates insulin dose, and sends delivery commands to the Pod for the delivery of insulin.
Control Group
n=27 Participants
Multiple daily injections of insulin with FreeStyle Libre 2 continuous glucose monitor
Percentage of Time in Range 70-180 mg/dL for Participants ≥18 Years of Age at Baseline
Baseline
40.67 Percentage of time
Standard Error 12.48
43.11 Percentage of time
Standard Error 14.23
Percentage of Time in Range 70-180 mg/dL for Participants ≥18 Years of Age at Baseline
13 Weeks
64.65 Percentage of time
Standard Error 8.05
41.66 Percentage of time
Standard Error 13.76

SECONDARY outcome

Timeframe: Comparing intervention group with control group at the end of the 13-week study phase

Glucose metric from CGM

Outcome measures

Outcome measures
Measure
Intervention Group
n=73 Participants
Omnipod 5 System with FreeStyle Libre 2 continuous glucose monitor Omnipod 5 System: The Omnipod 5 system is a tubeless patch pump that receives glucose values and trend data from the glucose sensor every 5 minutes, automatically calculates insulin dose, and sends delivery commands to the Pod for the delivery of insulin.
Control Group
n=35 Participants
Multiple daily injections of insulin with FreeStyle Libre 2 continuous glucose monitor
Percentage of Time in Range 70-180 mg/dL for Participants <18 Years of Age at Baseline
Baseline
38.55 Percentage of time
Standard Error 11.22
39.11 Percentage of time
Standard Error 12.20
Percentage of Time in Range 70-180 mg/dL for Participants <18 Years of Age at Baseline
13 Weeks
65.69 Percentage of time
Standard Error 7.22
44.07 Percentage of time
Standard Error 8.23

SECONDARY outcome

Timeframe: Comparing intervention group with control group at the end of the 13-week study phase

Population: Subjects are included in the Secondary Endpoint Analysis even if data for one period is missing.

Measured at baseline and 13 weeks in both intervention and control groups

Outcome measures

Outcome measures
Measure
Intervention Group
n=64 Participants
Omnipod 5 System with FreeStyle Libre 2 continuous glucose monitor Omnipod 5 System: The Omnipod 5 system is a tubeless patch pump that receives glucose values and trend data from the glucose sensor every 5 minutes, automatically calculates insulin dose, and sends delivery commands to the Pod for the delivery of insulin.
Control Group
n=31 Participants
Multiple daily injections of insulin with FreeStyle Libre 2 continuous glucose monitor
Change From Baseline in HbA1c in Participants With Baseline HbA1c ≥8%
Baseline
8.65 Percent of change
Standard Deviation 0.57
8.60 Percent of change
Standard Deviation 0.40
Change From Baseline in HbA1c in Participants With Baseline HbA1c ≥8%
13 Weeks
7.44 Percent of change
Standard Deviation 0.62
8.37 Percent of change
Standard Deviation 0.79

SECONDARY outcome

Timeframe: Comparing intervention group with control group at the end of the 13-week study phase

Population: Subjects are included in the Secondary Endpoint Analysis even if data for one period is missing.

The Pittsburgh Sleep Quality Index (PSQI) is a self-report scale assessing sleep quality over the past month. It produces a 0-21 total score, with higher scores indicating worse sleep quality. Results are reported as scores on a scale.

Outcome measures

Outcome measures
Measure
Intervention Group
n=125 Participants
Omnipod 5 System with FreeStyle Libre 2 continuous glucose monitor Omnipod 5 System: The Omnipod 5 system is a tubeless patch pump that receives glucose values and trend data from the glucose sensor every 5 minutes, automatically calculates insulin dose, and sends delivery commands to the Pod for the delivery of insulin.
Control Group
n=63 Participants
Multiple daily injections of insulin with FreeStyle Libre 2 continuous glucose monitor
Change From Baseline in PSQI Total Score
13 Weeks
5.03 Scores on a scale
Standard Deviation 2.82
5.91 Scores on a scale
Standard Deviation 3.61
Change From Baseline in PSQI Total Score
Baseline
5.05 Scores on a scale
Standard Deviation 2.65
5.71 Scores on a scale
Standard Deviation 3.49

SECONDARY outcome

Timeframe: Comparing intervention group with control group at the end of the 13-week study phase

Population: Subjects are included in the Secondary Endpoint Analysis even if data for one period is missing.

A questionnaire that measures seven critical dimensions of distress (28-item scale with 6 choices that range from 1 (Not a Problem) to 6 (A Very Serious Problem)). The total score can range from 1 to 6, with a lower score indicating a better outcome.

Outcome measures

Outcome measures
Measure
Intervention Group
n=52 Participants
Omnipod 5 System with FreeStyle Libre 2 continuous glucose monitor Omnipod 5 System: The Omnipod 5 system is a tubeless patch pump that receives glucose values and trend data from the glucose sensor every 5 minutes, automatically calculates insulin dose, and sends delivery commands to the Pod for the delivery of insulin.
Control Group
n=27 Participants
Multiple daily injections of insulin with FreeStyle Libre 2 continuous glucose monitor
Change From Baseline in T1-DDS Total Score for Participants ≥18 Years of Age at Baseline
Baseline
1.87 Scores on a scale
Standard Deviation 0.56
1.86 Scores on a scale
Standard Deviation 0.61
Change From Baseline in T1-DDS Total Score for Participants ≥18 Years of Age at Baseline
13 Weeks
1.59 Scores on a scale
Standard Deviation 0.49
1.72 Scores on a scale
Standard Deviation 0.51

SECONDARY outcome

Timeframe: Comparing intervention group with control group at the end of the 13-week study phase

Population: Subjects are included in the Secondary Endpoint Analysis even if data for one period is missing.

A questionnaire that examines the degree to which people with diabetes feel able, secure, and comfortable regarding their ability to stay safe from hypoglycemic-related problems (9-item scale with 4 choices that range from 1 (Not Confident At All) to 4 (Very Confident)). The total score can range from 1 to 4, with a higher score indicating a better outcome.

Outcome measures

Outcome measures
Measure
Intervention Group
n=52 Participants
Omnipod 5 System with FreeStyle Libre 2 continuous glucose monitor Omnipod 5 System: The Omnipod 5 system is a tubeless patch pump that receives glucose values and trend data from the glucose sensor every 5 minutes, automatically calculates insulin dose, and sends delivery commands to the Pod for the delivery of insulin.
Control Group
n=27 Participants
Multiple daily injections of insulin with FreeStyle Libre 2 continuous glucose monitor
Change From Baseline in HCS Total Score for Participants ≥18 Years of Age at Baseline
Baseline
3.46 Score on a scale
Standard Deviation 0.47
3.30 Score on a scale
Standard Deviation 0.54
Change From Baseline in HCS Total Score for Participants ≥18 Years of Age at Baseline
13 Weeks
3.48 Score on a scale
Standard Deviation 0.46
3.35 Score on a scale
Standard Deviation 0.57

SECONDARY outcome

Timeframe: Comparing intervention group with control group at the end of the 13-week study phase

Population: Subjects are included in the Secondary Endpoint Analysis even if data for one period is missing.

Glucose metric from CGM

Outcome measures

Outcome measures
Measure
Intervention Group
n=125 Participants
Omnipod 5 System with FreeStyle Libre 2 continuous glucose monitor Omnipod 5 System: The Omnipod 5 system is a tubeless patch pump that receives glucose values and trend data from the glucose sensor every 5 minutes, automatically calculates insulin dose, and sends delivery commands to the Pod for the delivery of insulin.
Control Group
n=63 Participants
Multiple daily injections of insulin with FreeStyle Libre 2 continuous glucose monitor
Percentage of Time <70 mg/dL
13 Weeks
2.84 Percent of time
Standard Deviation 1.73
3.50 Percent of time
Standard Deviation 3.53
Percentage of Time <70 mg/dL
Baseline
3.45 Percent of time
Standard Deviation 3.71
3.59 Percent of time
Standard Deviation 5.38

SECONDARY outcome

Timeframe: Comparing intervention group with control group at the end of the 13-week study phase

Population: Subjects are included in the Secondary Endpoint Analysis even if data for one period is missing.

Participants achieving HbA1C \< 7% \[N\]

Outcome measures

Outcome measures
Measure
Intervention Group
n=122 Participants
Omnipod 5 System with FreeStyle Libre 2 continuous glucose monitor Omnipod 5 System: The Omnipod 5 system is a tubeless patch pump that receives glucose values and trend data from the glucose sensor every 5 minutes, automatically calculates insulin dose, and sends delivery commands to the Pod for the delivery of insulin.
Control Group
n=60 Participants
Multiple daily injections of insulin with FreeStyle Libre 2 continuous glucose monitor
Percentage of Participants Achieving HbA1c <7%
Participants achieving HbA1c <7%
34 Participants
4 Participants
Percentage of Participants Achieving HbA1c <7%
Participants not achieving HbA1c <7%
88 Participants
56 Participants

SECONDARY outcome

Timeframe: Comparing intervention group with control group at the end of the 13-week study phase

Population: Subjects are included in the Secondary Endpoint Analysis even if data for one period is missing.

Change from baseline in the EQ-5D-3L index score, a standardized measure of health-related quality of life. Scores range from -0.594 to 1 (full health), with higher scores indicating better health status.

Outcome measures

Outcome measures
Measure
Intervention Group
n=125 Participants
Omnipod 5 System with FreeStyle Libre 2 continuous glucose monitor Omnipod 5 System: The Omnipod 5 system is a tubeless patch pump that receives glucose values and trend data from the glucose sensor every 5 minutes, automatically calculates insulin dose, and sends delivery commands to the Pod for the delivery of insulin.
Control Group
n=63 Participants
Multiple daily injections of insulin with FreeStyle Libre 2 continuous glucose monitor
Change From Baseline in EQ-5D-3L Index Score
Baseline
0.94 Score on a scale
Standard Deviation 0.12
0.93 Score on a scale
Standard Deviation 0.16
Change From Baseline in EQ-5D-3L Index Score
13 Weeks
0.93 Score on a scale
Standard Deviation 0.13
0.92 Score on a scale
Standard Deviation 0.14

SECONDARY outcome

Timeframe: Comparing intervention group with control group at the end of the 13-week study phase

Population: Subjects are included in the Secondary Endpoint Analysis even if data for one period is missing.

Measure of insulin requirements measured at 13 weeks in both intervention and control groups

Outcome measures

Outcome measures
Measure
Intervention Group
n=52 Participants
Omnipod 5 System with FreeStyle Libre 2 continuous glucose monitor Omnipod 5 System: The Omnipod 5 system is a tubeless patch pump that receives glucose values and trend data from the glucose sensor every 5 minutes, automatically calculates insulin dose, and sends delivery commands to the Pod for the delivery of insulin.
Control Group
n=27 Participants
Multiple daily injections of insulin with FreeStyle Libre 2 continuous glucose monitor
Change From Baseline in Total Daily Insulin (TDI) (Units/kg) for Participants ≥18 Years of Age
Baseline
0.72 Change from Baseline (units/kg)
Standard Deviation 0.24
0.62 Change from Baseline (units/kg)
Standard Deviation 0.22
Change From Baseline in Total Daily Insulin (TDI) (Units/kg) for Participants ≥18 Years of Age
13 Weeks
0.67 Change from Baseline (units/kg)
Standard Deviation 0.23
0.63 Change from Baseline (units/kg)
Standard Deviation 0.24

SECONDARY outcome

Timeframe: Comparing intervention group with control group at the end of the 13-week study phase

Population: Subjects are included in the Secondary Endpoint Analysis even if data for one period is missing.

Glucose metric from CGM

Outcome measures

Outcome measures
Measure
Intervention Group
n=125 Participants
Omnipod 5 System with FreeStyle Libre 2 continuous glucose monitor Omnipod 5 System: The Omnipod 5 system is a tubeless patch pump that receives glucose values and trend data from the glucose sensor every 5 minutes, automatically calculates insulin dose, and sends delivery commands to the Pod for the delivery of insulin.
Control Group
n=63 Participants
Multiple daily injections of insulin with FreeStyle Libre 2 continuous glucose monitor
Percentage of Time <54 mg/dL
Baseline
0.61 Percentage of time
Standard Deviation 1.49
0.95 Percentage of time
Standard Deviation 2.23
Percentage of Time <54 mg/dL
13 Weeks
0.49 Percentage of time
Standard Deviation 0.52
0.63 Percentage of time
Standard Deviation 1.03

Adverse Events

Intervention Group

Serious events: 2 serious events
Other events: 26 other events
Deaths: 0 deaths

Control Group

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Intervention Group
n=125 participants at risk
Omnipod 5 System with FreeStyle Libre 2 continuous glucose monitor Omnipod 5 System: The Omnipod 5 system is a tubeless patch pump that receives glucose values and trend data from the glucose sensor every 5 minutes, automatically calculates insulin dose, and sends delivery commands to the Pod for the delivery of insulin.
Control Group
n=63 participants at risk
Multiple daily injections of insulin with FreeStyle Libre 2 continuous glucose monitor
Vascular disorders
Other
0.80%
1/125 • Number of events 1 • Start time of the standard therapy (14-days prior to Study Day 1) and continued until the participant's participation ended, up to 13 weeks.
0.00%
0/63 • Start time of the standard therapy (14-days prior to Study Day 1) and continued until the participant's participation ended, up to 13 weeks.
Cardiac disorders
Other
0.80%
1/125 • Number of events 1 • Start time of the standard therapy (14-days prior to Study Day 1) and continued until the participant's participation ended, up to 13 weeks.
0.00%
0/63 • Start time of the standard therapy (14-days prior to Study Day 1) and continued until the participant's participation ended, up to 13 weeks.

Other adverse events

Other adverse events
Measure
Intervention Group
n=125 participants at risk
Omnipod 5 System with FreeStyle Libre 2 continuous glucose monitor Omnipod 5 System: The Omnipod 5 system is a tubeless patch pump that receives glucose values and trend data from the glucose sensor every 5 minutes, automatically calculates insulin dose, and sends delivery commands to the Pod for the delivery of insulin.
Control Group
n=63 participants at risk
Multiple daily injections of insulin with FreeStyle Libre 2 continuous glucose monitor
Investigations
Other
13.6%
17/125 • Number of events 21 • Start time of the standard therapy (14-days prior to Study Day 1) and continued until the participant's participation ended, up to 13 weeks.
4.8%
3/63 • Number of events 3 • Start time of the standard therapy (14-days prior to Study Day 1) and continued until the participant's participation ended, up to 13 weeks.
Endocrine disorders
Hyperglycemia
4.0%
5/125 • Number of events 8 • Start time of the standard therapy (14-days prior to Study Day 1) and continued until the participant's participation ended, up to 13 weeks.
0.00%
0/63 • Start time of the standard therapy (14-days prior to Study Day 1) and continued until the participant's participation ended, up to 13 weeks.
Endocrine disorders
Prolonged Hyperglycemia
6.4%
8/125 • Number of events 8 • Start time of the standard therapy (14-days prior to Study Day 1) and continued until the participant's participation ended, up to 13 weeks.
0.00%
0/63 • Start time of the standard therapy (14-days prior to Study Day 1) and continued until the participant's participation ended, up to 13 weeks.

Additional Information

Dr. Trang Ly

Insulet Corporation

Phone: 9786007628

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place