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Trial Outcomes & Findings for Routine Use of Sensor-Augmented Pump Therapy - a Follow up Study (NCT NCT01451372)

NCT ID: NCT01451372

Last Updated: 2019-02-27

Results Overview

Daily usage of blood glucose test 0-24 months after CGM usage. This information is collected in a journal questionnaire

Recruitment status

COMPLETED

Target enrollment

69 participants

Primary outcome timeframe

24 months

Results posted on

2019-02-27

Participant Flow

Participant milestones

Participant milestones
Measure
Type 1 Diabetes Subjects Using CGM
Type 1 Diabetes Subjects using CGM in Sweden
Overall Study
STARTED
69
Overall Study
COMPLETED
69
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Routine Use of Sensor-Augmented Pump Therapy - a Follow up Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Type 1 Diabetes Subjects Using CGM
n=69 Participants
Type 1 Diabetes Subjects using CGM in Sweden
Age, Customized
Age, Continuous
33 years
n=5 Participants
Sex: Female, Male
Female
47 Participants
n=5 Participants
Sex: Female, Male
Male
22 Participants
n=5 Participants
Region of Enrollment
Sweden
69 participants
n=5 Participants

PRIMARY outcome

Timeframe: 24 months

Population: journal questionnaires about blood glucose testing were collected from 65 out of 69 subjects

Daily usage of blood glucose test 0-24 months after CGM usage. This information is collected in a journal questionnaire

Outcome measures

Outcome measures
Measure
Type 1 Diabetes Subjects Using CGM
n=65 Participants
Type 1 Diabetes Subjects using CGM in Sweden
Daily Usage of Blood Glucose Test (BG Testing)
4.35 number of blood glucose test per day
Standard Deviation 2.4

SECONDARY outcome

Timeframe: 24 months

Population: Journal questionnaires about sensor usage were collected from 61 out of 69 subjects

Frequency of sensor usage per month during the study. This information is collected in a journal questionnaire

Outcome measures

Outcome measures
Measure
Type 1 Diabetes Subjects Using CGM
n=61 Participants
Type 1 Diabetes Subjects using CGM in Sweden
Frequency of Sensor Usage Per Month
4 number of sensor used per month
Standard Deviation 1.5

Adverse Events

Type 1 Diabetes Subjects Using CGM

Serious events: 0 serious events
Other events: 18 other events
Deaths: 18 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Type 1 Diabetes Subjects Using CGM
n=69 participants at risk
Type 1 Diabetes Subjects using CGM in Sweden
Infections and infestations
Infection
7.2%
5/69 • Number of events 5 • 24 month
Skin and subcutaneous tissue disorders
Skin Irritation
21.7%
15/69 • Number of events 15 • 24 month
Immune system disorders
Inflammation
4.3%
3/69 • Number of events 3 • 24 month
Injury, poisoning and procedural complications
Bleeding
1.4%
1/69 • Number of events 1 • 24 month
General disorders
Other
2.9%
2/69 • Number of events 2 • 24 month

Additional Information

Suiying Huang, Statistician

Medtronic Minimed

Phone: 8184763319

Results disclosure agreements

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

Restriction type: GT60