Qingdao: Insulin Pump Follow-Up Program

Qingdao: Insulin Pump Follow-up Program

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02655666

Enrollment

Registered

2016-01-14

Start date

2015-04-30

Completion date

2016-09-30

Last updated

2019-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

Brief summary

The purpose of the study is to observe/ collect clinical data, subject users' feedback, and device data to better understand the real-life usage and acceptance of the 722 Pump in type 1 diabetes subjects,\<18 years of age, and the role of insulin pump therapy in Qingdao,China.

Detailed description

This is a prospective, multi-center, non-randomized and noninterventional post-market release study. Subjects will participate in 2 phases with each phase requiring the subject to use the continuous subcutaneous insulin infusion (CSII) pump over the course of the study. During the study, subjects and parent or legal guardian will be trained to wear the glucose sensor in the abdominal area for 3 days to transmit real-time (RT) data to the pump. The duration of each study phase is approximately 6 months.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 18 Years

Healthy volunteers

Inclusion criteria

* Subject is age \< 18 years at time of screening * Subject has a clinical diagnosis of type 1 diabetes * Subject is willing to perform required sensor calibrations * Subject is willing to wear the Medtronic MiniMed Paradigm® REAL Time System continuously throughout the study * Subject is a participant in the Qingdao project.

Exclusion criteria

* Subject is actively participating in an investigational study (drug or device) wherein he/she has received diabetes treatment from an investigational study drug or investigational study devices in the last 2 weeks * Subject has known hypersensitivity to insulin or insulin infusion set(including tape) * Subject has used the insulin pump and/or real time CGM/sensor within 90 days before the screening visit for more than 10 days in the outpatient setting: * For example, subjects who have used insulin pump and/or real time CGM/sensor in the inpatient setting will still be eligible for enrollment. * For example, subjects who have used insulin pump and/or real time CGM/sensor for 8 days in the outpatient setting within 90 days before screening visit will still be eligible for enrollment. * For example, subjects who have worn the insulin pump and/or real time CGM/sensor for 3 months in the outpatient setting a year before the screening visit will still be eligible for enrollment * Subject has been treated with drugs with a known effect on BG within 8 weeks before enrollment other than diabetes medications such as insulin or oral anti-diabetic agents. * Subject has any systemic disease or medical condition found on screening that may interfere with the safety of the patient and efficacy of the study treatment, in the opinion of the Investigator, may preclude him/her from participating in the study. * Subject is being treated for hyperthyroidism at time of screening * Subject has taken any oral, injectable, or IV steroids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV steroids during the course of the study * Subject is currently abusing alcohol9. Any condition that either the Investigator believes would interfere with study participation or evaluation of results.

Design outcomes

Primary

Measure	Time frame	Description
Change in Glycosylated Hemoglobin (A1C)	Change in A1C from baseline to end of study (1 year)	The change of A1C from baseline to end of study (1 year) will be presented

Secondary

Measure	Time frame	Description
Standard Deviation of Glucose Value Based on Continuous Glucose Monitoring Data	Data is collected 7 days following the end of each period (At end of month 3, no glucose data is collected.).	The standard deviation of all available glucose value of each subject for each evaluation period is calculated, and then we present the mean and std of the individual standard deviation for each evaluation period.
Coefficient of Variation of Glucose Value Per Each Subject Based on Continuous Glucose Monitoring Data	Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).	The coefficient of variation of all available glucose value of each subject for each evaluation period is calculated, and then we present the mean and std of the individual coefficient of variation for each evaluation period.
Mean Amplitude of Glycemic Excursion Based on Continuous Glucose Monitoring Data	Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).	Mean Amplitude of Glycemic Excursion (which is often used to characterize glycemic variability, to know the detail of calculation, please refer to Glucose Variability, © 2013 by the American Diabetes Association. ) of each subject for each evaluation period is calculated, and then we present the mean and std of the individual Mean Amplitude of Glycemic Excursion for each evaluation period.
Number of Events in the Hypoglycemic Range	Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).	Number of events in the hypoglycemic range (SG≤3.9mmol/L) of all available glucose value of each subject for each evaluation period is calculated, and then we present the mean and std of the individual number of events for each evaluation period.
Average Glucose Values Based on Continuous Glucose Monitoring Data	Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).	The average glucose value of all available glucose value of each subject for each evaluation period is calculated, and we present the mean and std of the individual average glucose value for each evaluation period.
Area Under Curve in the Hypoglycemic Range	Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).	Area under Curve in the hypoglycemic range (SG≤3.9mmol/L) of all available glucose value of each subject for each evaluation period is calculated, and then we present the mean and std of the individual Area under Curve for each evaluation period.
Area Under Curve in the Hyperglycemic Range	Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).	Area under Curve in the hyperglycemic range (SG≥10.0 mmol/L) based on all available glucose value of each subject for each evaluation period is calculated, and then we present the mean and std of the individual Area under Curve for each evaluation period.
Percentage of Time in the Hypoglycemic Range	Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).	Percentage of time in the hypoglycemic range (SG ≤ 3.9 mmol/L) of all available glucose value of each subject for each evaluation period is calculated, and then we present the mean and std of the individual percetage of time in that range for each evaluation period.
Percentage of Time in the Hyperglycemic Range	Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).	Percentage of time in the hyperglycemic range (SG≥10.0 mmol/L) of all available glucose value of each subject for each evaluation period is calculated, and then we present the mean and std of the individual percentage of time in that range for each evaluation period.
Number of Events in the Hyperglycemic Range	Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).	Number of Events in the Hyperglycemic Range (SG≥10.0 mmol/L) of all available glucose value of each subject for each evaluation period is calculated, and then we present the mean and std of the individual number of events for each evaluation period.

Countries

China

Participant flow

Participants by arm

Arm	Count
Medtronic MiniMed Paradigm® REAL-Time System Medtronic MiniMed Paradigm® REAL-Time System consisting of Paradigm 722 Insulin Pump (MMT-722), Medtronic MiniLink® REAL-Time Transmitter (MMT-7703) and Sof-Sensor® (MMT-7003) Glucose Sensor	16
Total	16

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Sponsor stopped this clinical research.	12

Baseline characteristics

Characteristic	Medtronic MiniMed Paradigm® REAL-Time System
Age, Continuous	11.3 years STANDARD_DEVIATION 2.85
Region of Enrollment China	16 participants
Sex: Female, Male Female	11 Participants
Sex: Female, Male Male	5 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 16
other Total, other adverse events	0 / 16
serious Total, serious adverse events	2 / 16

Outcome results

Primary

Change in Glycosylated Hemoglobin (A1C)

The change of A1C from baseline to end of study (1 year) will be presented

Time frame: Change in A1C from baseline to end of study (1 year)

Population: Subject completed the study.

Arm	Measure	Value (MEAN)	Dispersion
Medtronic MiniMed Paradigm® REAL-Time System	Change in Glycosylated Hemoglobin (A1C)	0.9 percent Glycosylated Hemoglobin	Standard Deviation 2.22

Secondary

Area Under Curve in the Hyperglycemic Range

Area under Curve in the hyperglycemic range (SG≥10.0 mmol/L) based on all available glucose value of each subject for each evaluation period is calculated, and then we present the mean and std of the individual Area under Curve for each evaluation period.

Time frame: Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).