Trial Outcomes & Findings for CareLink Connect - Technical Evaluation Study (NCT NCT01989975)

NCT ID: NCT01989975

Last Updated: 2019-02-21

Results Overview

The overall system connectivity between the pump, the CareLink Connect device, and the CareLink server will be measured. CareLink Connect activity will be measured by: * Date and time of CareLink Connect transmissions * Transmission type and data sent in CareLink Connect transmissions (includes RF messages and history uploads)

• Recruitment status: COMPLETED
• Target enrollment: 40 participants
• Primary outcome timeframe: Outcome measured after 15 days of use of the CareLink Connect Device
• Results posted on: 2019-02-21

Participant Flow

Participant milestones

Measure	Diabetes Subjects With Sensor-Augmented Pump Therapy Subjects with diabetes mellitus treated with Sensor-Augmented Pump therapy participated the study for 15 days
Overall Study STARTED	40
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

CareLink Connect - Technical Evaluation Study

Baseline characteristics by cohort

Measure	Diabetes Subjects With Sensor-Augmented Pump Therapy n=40 Participants Subjects with diabetes mellitus treated with Sensor-Augmented Pump therapy participated the study for 15 days
Age, Continuous	29.4 years STANDARD_DEVIATION 18.7 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants
Region of Enrollment Netherlands	25 Participants n=5 Participants
Region of Enrollment Denmark	15 Participants n=5 Participants

PRIMARY outcome

Timeframe: Outcome measured after 15 days of use of the CareLink Connect Device

The overall system connectivity between the pump, the CareLink Connect device, and the CareLink server will be measured. CareLink Connect activity will be measured by:

• Date and time of CareLink Connect transmissions
• Transmission type and data sent in CareLink Connect transmissions (includes RF messages and history uploads)

Outcome measures

Measure	Diabetes Subjects With Sensor-Augmented Pump Therapy n=40 Participants Subjects with diabetes mellitus treated with Sensor-Augmented Pump therapy participated the study for 15 days
CareLink Connect Activity: % of the Time Per Day When Cellular Connection Was Established	89.3 percentage of time spent connected Standard Deviation 12.4

PRIMARY outcome

Timeframe: Outcome measured after 15 days of use of the CareLink Connect Device

Subject experience after using the Carelink Connect device was evaluated with questionnaires. Subjects were asked the question: I felt that I had good control over my diabetes. Likert Scale of 1-7 was used in the study to evaluate the question (1 being the the worse, 4 being neutral and 7 being the best).

Outcome measures

Measure	Diabetes Subjects With Sensor-Augmented Pump Therapy n=40 Participants Subjects with diabetes mellitus treated with Sensor-Augmented Pump therapy participated the study for 15 days
Subject Experience After Using the Carelink Connect Device	5.6 Scores on a Scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: Outcome measured after 15 days of use of the CareLink Connect Device

Descriptive summary of number and type of serious adverse events (SAE)

Outcome measures

Measure	Diabetes Subjects With Sensor-Augmented Pump Therapy n=40 Participants Subjects with diabetes mellitus treated with Sensor-Augmented Pump therapy participated the study for 15 days
Number of Participants With Serious Adverse Events	0 Participants

SECONDARY outcome

Timeframe: Outcome measured after 15 days of use of the CareLink Connect Device

Subjects were instructed to report any inadequacies of a medical device including:

• Lack of connection between the CareLink Connect device and the Veo pump (Connectivity issues)
• Device Battery issue
• Device information display issue

Outcome measures

Measure	Diabetes Subjects With Sensor-Augmented Pump Therapy n=40 Participants Subjects with diabetes mellitus treated with Sensor-Augmented Pump therapy participated the study for 15 days
Number of Participants With Investigational Device Deficiencies Connectivity issues	22 Participants
Number of Participants With Investigational Device Deficiencies Device battery issues	2 Participants
Number of Participants With Investigational Device Deficiencies Information display issues	4 Participants
Number of Participants With Investigational Device Deficiencies No Issues	12 Participants

Adverse Events

Diabetes Subjects With Sensor-Augmented Pump Therapy

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Diabetes Subjects With Sensor-Augmented Pump Therapy n=40 participants at risk Subjects with diabetes mellitus treated with Sensor-Augmented Pump therapy participated the study for 15 days
Nervous system disorders Headache	2.5% 1/40 • Number of events 1 • 15 days
Infections and infestations Gastroenteritis	5.0% 2/40 • Number of events 2 • 15 days
Infections and infestations Severe common cold	2.5% 1/40 • Number of events 1 • 15 days
Gastrointestinal disorders Minor nausea	2.5% 1/40 • Number of events 1 • 15 days
Nervous system disorders Migraine	2.5% 1/40 • Number of events 1 • 15 days
Infections and infestations Cold	2.5% 1/40 • Number of events 1 • 15 days
Infections and infestations Fever	2.5% 1/40 • Number of events 1 • 15 days
Infections and infestations Infection external ear	2.5% 1/40 • Number of events 1 • 15 days

Additional Information

Suiying Huang, Statistician

Medtronic Minimed

Phone: 8184763319

Email: suiying.huang@medtronic.com

Results disclosure agreements

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

Restriction type: GT60