Trial Outcomes & Findings for INTERPRET - International Report on Routine Practice of Sensor-enabled Pump Therapy (NCT NCT00790088)
NCT ID: NCT00790088
Last Updated: 2019-02-20
Results Overview
To calculate the percentage of time that sensors were used during 3 months: the total number of recorded sensor readings during 3 months was divided by the theoretical number of sensor readings that would be observed if sensor was worn every day of using pump to deliver insulin during the same period (ie, observed readings / (theoretical 288 readings per day x nber of days with insulin use)) and multiplied by 100
COMPLETED
274 participants
every 3 months
2019-02-20
Participant Flow
At baseline, few patients had to be excluded from analyses due to major protocol deviations such as missing patient informed consent, CSII therapy for less than 6 months, prior experience with SAP therapy, and no eCRF data information available. Hence 263 patients were eligible for analyses at baseline.
Participant milestones
| Measure |
Sensor-augmented Pump
CSII patient who were prescribed the use of continuous glucose monitoring (CGM) for at least 10% of the time
|
|---|---|
|
Overall Study
STARTED
|
274
|
|
Overall Study
Eligible for Data Analysis
|
263
|
|
Overall Study
COMPLETED
|
235
|
|
Overall Study
NOT COMPLETED
|
39
|
Reasons for withdrawal
| Measure |
Sensor-augmented Pump
CSII patient who were prescribed the use of continuous glucose monitoring (CGM) for at least 10% of the time
|
|---|---|
|
Overall Study
Protocol Violation
|
11
|
|
Overall Study
Withdrawal by Subject
|
17
|
|
Overall Study
Lost to Follow-up
|
7
|
|
Overall Study
Physician Decision
|
4
|
Baseline Characteristics
INTERPRET - International Report on Routine Practice of Sensor-enabled Pump Therapy
Baseline characteristics by cohort
| Measure |
Sensor-augmented Pump
n=263 Participants
CSII patient who were prescribed the use of continuous glucose monitoring (CGM) for at least 10% of the time
|
|---|---|
|
Age, Continuous
|
28.04 years
STANDARD_DEVIATION 15.72 • n=5 Participants
|
|
Age, Customized
<=7 years
|
28 participants
n=5 Participants
|
|
Age, Customized
8 - 12
|
21 participants
n=5 Participants
|
|
Age, Customized
13-17
|
35 participants
n=5 Participants
|
|
Age, Customized
18-24
|
27 participants
n=5 Participants
|
|
Age, Customized
>24
|
152 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
164 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
99 Participants
n=5 Participants
|
|
Region of Enrollment
Serbia
|
20 participants
n=5 Participants
|
|
Region of Enrollment
Slovenia
|
20 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
22 participants
n=5 Participants
|
|
Region of Enrollment
Lithuania
|
14 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
14 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
18 participants
n=5 Participants
|
|
Region of Enrollment
Slovakia
|
4 participants
n=5 Participants
|
|
Region of Enrollment
France
|
22 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
39 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
17 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
20 participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
28 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
12 participants
n=5 Participants
|
|
Region of Enrollment
Czechia
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: every 3 monthsTo calculate the percentage of time that sensors were used during 3 months: the total number of recorded sensor readings during 3 months was divided by the theoretical number of sensor readings that would be observed if sensor was worn every day of using pump to deliver insulin during the same period (ie, observed readings / (theoretical 288 readings per day x nber of days with insulin use)) and multiplied by 100
Outcome measures
| Measure |
Whole Population
n=263 Participants
all available data from eligible patients at baseline
|
|---|---|
|
Frequency as Percentage of Sensor Usage
Baseline - 3 months
|
37 % of time
Standard Deviation 29
|
|
Frequency as Percentage of Sensor Usage
3 months - 6 months
|
31 % of time
Standard Deviation 28
|
|
Frequency as Percentage of Sensor Usage
6 months - 9 months
|
28 % of time
Standard Deviation 28
|
|
Frequency as Percentage of Sensor Usage
9 months - 12 months
|
27 % of time
Standard Deviation 28
|
|
Frequency as Percentage of Sensor Usage
baseline - 12 months
|
30 % of time
Standard Deviation 26
|
PRIMARY outcome
Timeframe: every 3 monthsOutcome measures
| Measure |
Whole Population
n=263 Participants
all available data from eligible patients at baseline
|
|---|---|
|
HbA1c
Baseline
|
8.1 percent
Standard Deviation 1.4
|
|
HbA1c
3Months
|
7.87 percent
Standard Deviation 1.2
|
|
HbA1c
6Months
|
7.9 percent
Standard Deviation 1.17
|
|
HbA1c
9Months
|
7.98 percent
Standard Deviation 1.14
|
|
HbA1c
12Months
|
8.05 percent
Standard Deviation 1.23
|
PRIMARY outcome
Timeframe: every 3 monthsOutcome measures
| Measure |
Whole Population
n=263 Participants
all available data from eligible patients at baseline
|
|---|---|
|
Percentage of Patients Achieving HbA1c < 7%
6 months
|
18.22 percent of patients
|
|
Percentage of Patients Achieving HbA1c < 7%
9 months
|
17.72 percent of patients
|
|
Percentage of Patients Achieving HbA1c < 7%
12 months
|
16.02 percent of patients
|
|
Percentage of Patients Achieving HbA1c < 7%
Baseline
|
18.25 percent of patients
|
|
Percentage of Patients Achieving HbA1c < 7%
3 months
|
18.5 percent of patients
|
PRIMARY outcome
Timeframe: every 3 monthsOutcome measures
| Measure |
Whole Population
n=263 Participants
all available data from eligible patients at baseline
|
|---|---|
|
Percentage of Patients Achieving HbA1c < 7.5%
Baseline
|
28.52 percent of patients
|
|
Percentage of Patients Achieving HbA1c < 7.5%
3 months
|
36.22 percent of patients
|
|
Percentage of Patients Achieving HbA1c < 7.5%
6 months
|
32.79 percent of patients
|
|
Percentage of Patients Achieving HbA1c < 7.5%
9 months
|
31.65 percent of patients
|
|
Percentage of Patients Achieving HbA1c < 7.5%
12 months
|
33.33 percent of patients
|
SECONDARY outcome
Timeframe: at baseline, after 6 and after 12 monthssub-group of patients (adults only in Hungary and Denmark) were asked to answer the fear of hypoglycemia validated questionnaires. The total HFS-II questionnaire is represented by 33 items. The respondents rank the responses on a 5- point Likert scale where zero is never and four is always.The total HFS-II score ranges from 0 to 132. Lower score at 6 months or 12 months compared to baseline represents a better outcome. The HFS-II questionnaire is divided into 2 subscales: the behavior and the worry subscales. The behavior score is represented by 15 items and ranges from 0 to 60. Lower score at 6 months or 12 months compared to baseline represents a better outcome.
Outcome measures
| Measure |
Whole Population
n=40 Participants
all available data from eligible patients at baseline
|
|---|---|
|
Fear of Hypoglycemia Survey (HFS-II) - Total Score and Behavior Score
Total score at baseline
|
37 Score
Standard Deviation 25.94
|
|
Fear of Hypoglycemia Survey (HFS-II) - Total Score and Behavior Score
Total score at 6Months
|
32.74 Score
Standard Deviation 21.24
|
|
Fear of Hypoglycemia Survey (HFS-II) - Total Score and Behavior Score
Total score at 12Months
|
28.95 Score
Standard Deviation 20.11
|
|
Fear of Hypoglycemia Survey (HFS-II) - Total Score and Behavior Score
Behavior Score at baseline
|
16.03 Score
Standard Deviation 10.71
|
|
Fear of Hypoglycemia Survey (HFS-II) - Total Score and Behavior Score
Behavior score at 6Months
|
14.56 Score
Standard Deviation 9.06
|
|
Fear of Hypoglycemia Survey (HFS-II) - Total Score and Behavior Score
Behavior score at 12Months
|
13.35 Score
Standard Deviation 8.81
|
SECONDARY outcome
Timeframe: at baseline, after 6 and after 12 monthssub-group of patients (adults only) were asked to answer the fear of hypoglycemia validated questionnaires. The respondents rank the responses on a 5- point Likert scale where zero is never and four is always. The worry subscale is the mean of 18 items which evaluate the worry score (range from 0 to 72). Lower score at 6 months or 12 months compared to baseline represents a better outcome.
Outcome measures
| Measure |
Whole Population
n=61 Participants
all available data from eligible patients at baseline
|
|---|---|
|
Fear of Hypoglycemia Survey (HFS-II) - Worry Score
Worry score at baseline
|
23.39 Score
Standard Deviation 15.65
|
|
Fear of Hypoglycemia Survey (HFS-II) - Worry Score
Worry score at 6Months
|
20.65 Score
Standard Deviation 15.37
|
|
Fear of Hypoglycemia Survey (HFS-II) - Worry Score
Worry score at 12Months
|
18.40 Score
Standard Deviation 14.84
|
SECONDARY outcome
Timeframe: at baseline, after 3 and after 12 monthsA sub-group of patients (adults) were asked to complete the Diabetes Treatment Satisfaction Questionnaire (DTSQs) The treatment satisfaction is measured by means of the Diabetes Treatment Satisfaction Questionnaire, status version (DTSQs, Bradley, 1990). It consists of a six-item scale assessing treatment satisfaction (TS) and two items assessing perceived frequency of hyperglycaemia and hypoglycaemia. The DTSQs items are scored on a scale from 6 to 0. The scale total is computed by adding the six items 1, 4, 5, 6, 7, and 8, to produce the Treatment Satisfaction scale total, which has a min of 0 and a max of 36. Higher score at 6 month or 12 months compared to baseline represents a better outcome. Items 2 (perceived frequency of hyperglycaemia) and 3 (perceived frequency of hypoglycaemia) are treated individually in data analysis. Lower score at 6 months or 12 months compared to baseline represents a better outcome.
Outcome measures
| Measure |
Whole Population
n=66 Participants
all available data from eligible patients at baseline
|
|---|---|
|
Diabetes Treatment Satisfaction Questionnaire Status Version (DTSQs)
Diatbetes Treatment satisfaction score at baseline
|
31.42 score
Standard Deviation 3.15
|
|
Diabetes Treatment Satisfaction Questionnaire Status Version (DTSQs)
Treatment satisfaction score at 3Months
|
30.80 score
Standard Deviation 4.33
|
|
Diabetes Treatment Satisfaction Questionnaire Status Version (DTSQs)
Treatment satisafaction score at 12Months
|
32 score
Standard Deviation 3.29
|
|
Diabetes Treatment Satisfaction Questionnaire Status Version (DTSQs)
Perceived Frequency Hypoglycaemia at baseline
|
2.18 score
Standard Deviation 1.28
|
|
Diabetes Treatment Satisfaction Questionnaire Status Version (DTSQs)
Perceived Frequency Hypoglycaemia at 3Months
|
2.5 score
Standard Deviation 1.32
|
|
Diabetes Treatment Satisfaction Questionnaire Status Version (DTSQs)
Perceived Frequency Hypoglycaemia at 12Months
|
2.03 score
Standard Deviation 1.16
|
|
Diabetes Treatment Satisfaction Questionnaire Status Version (DTSQs)
Perceived Frequency Hyperglycaemia at baseline
|
2.83 score
Standard Deviation 1.30
|
|
Diabetes Treatment Satisfaction Questionnaire Status Version (DTSQs)
Perceived Frequency Hyperglycaemia at 3Months
|
2.67 score
Standard Deviation 1.17
|
|
Diabetes Treatment Satisfaction Questionnaire Status Version (DTSQs)
Perceived Frequency Hyperglycaemia at 12Months
|
2.35 score
Standard Deviation 1.33
|
Adverse Events
Sensor-augmented Pump
Serious adverse events
| Measure |
Sensor-augmented Pump
n=263 participants at risk
CSII patient who were prescribed the use of continuous glucose monitoring (CGM) for at least 10% of the time
|
|---|---|
|
Endocrine disorders
Diabetic ketoacidosis
|
1.1%
3/263 • Number of events 3 • During the 12Months follow-up
Only Serious adverse events were collected
|
|
Endocrine disorders
Severe hypoglycemia
|
3.4%
9/263 • Number of events 13 • During the 12Months follow-up
Only Serious adverse events were collected
|
|
Endocrine disorders
Other diabetes-related AE
|
2.3%
6/263 • Number of events 6 • During the 12Months follow-up
Only Serious adverse events were collected
|
|
Endocrine disorders
Non Diabetes-related serious adverse events
|
2.3%
6/263 • Number of events 6 • During the 12Months follow-up
Only Serious adverse events were collected
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60