Diabetes Mellitus, Type 1
Conditions
Keywords
Diabetes Mellitus, Type 1, continuous glucose monitoring, sensor-augmented pump therapy
Brief summary
The aim of the project is to document the international routine practice in sensor usage in patients treated with sensor-augmented pump therapy and to assess which variables (e.g. training of patients, frequency of sensor usage etc) are associated with an improvement in clinical outcome(s) from the start of the sensor use to the end of the follow-up period.
Detailed description
Pump therapy has been established as gold standard for insulin delivery offering improvements over multiple daily insulin injections, but there is a proportion of patients for whom the Continuous Subcutaneous Insulin Infusion (CSII) has not been completely successful therapy leaving some room for improvement of the glucose level of those patients. Continuous glucose monitoring (CGM) systems represent an important advance in diabetes technology that can facilitate optimal glucose control in type 1 diabetes. Numerous randomized control trials have demonstrated the safety and efficacy of real-time CGM in both sub-optimally and well-controlled type 1 diabetes. In all these trials, the benefits of CGM correlate with frequent sensor wear and more advanced age. In clinical practice, the sensor-augmented pump therapy (SAP therapy) is indicated for patients who cannot achieve good metabolic control on CSII, who have a history of severe hypoglycemia and/or hypoglycemia unawareness, or who desire increased flexibility in their daily lives while maintaining or even improving their HbA1c levels. This was a post-market release, minimally interventional study. All the study devices and related software were CE-marked and commercially available in the countries participating to the study. The devices were prescribed and reimbursed, if applicable, according to routine practice. The gathered information during this study may help to define which patient groups benefit the most from the treatment with SAP therapy systems. The real-life results of these descriptive analyses will aid improvement of guidelines helping the medical community to better choose the right patient population and treatment patterns. Moreover, based on these real-life data, hypotheses could be defined when addressing further research questions.
Interventions
None listed
Sponsors
Medtronic Diabetes
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patient (and/or legal representative) has signed Patient Informed Consent (PIC) * Patient was diagnosed with Type 1 DM and has been on insulin infusion pump therapy (without any additional insulin injection) for at least 6 months prior to signature of the PIC * The treating physician decided independently of the study to prescribe non-blinded continuous glucose monitoring as part of the patient's pump therapy for at least 10% of the study time (estimated as days per month)
Exclusion criteria
* Participation in any other clinical trial - currently and/or in the last 3 months prior to signature of informed consent * Patient has preliminary experience with non-blinded continuous glucose monitoring prior to signature of informed consent (not naïve to non-blinded continuous glucose monitoring) * For children: no reliable contact person
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency as Percentage of Sensor Usage | every 3 months | 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 |
| HbA1c | every 3 months | — |
| Percentage of Patients Achieving HbA1c < 7% | every 3 months | — |
| Percentage of Patients Achieving HbA1c < 7.5% | every 3 months | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fear of Hypoglycemia Survey (HFS-II) - Worry Score | at baseline, after 6 and after 12 months | sub-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. |
| Diabetes Treatment Satisfaction Questionnaire Status Version (DTSQs) | at baseline, after 3 and after 12 months | A 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. |
| Fear of Hypoglycemia Survey (HFS-II) - Total Score and Behavior Score | at baseline, after 6 and after 12 months | sub-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. |
Countries
Austria, Belgium, Denmark, France, Hungary, Israel, Italy, Lithuania, Poland, Serbia, Slovakia, Slovenia, Spain, Sweden
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Sensor-augmented Pump CSII patient who were prescribed the use of continuous glucose monitoring (CGM) for at least 10% of the time | 263 |
| Total | 263 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 7 |
| Overall Study | Physician Decision | 4 |
| Overall Study | Protocol Violation | 11 |
| Overall Study | Withdrawal by Subject | 17 |
Baseline characteristics
| Characteristic | Sensor-augmented Pump |
|---|---|
| Age, Continuous | 28.04 years STANDARD_DEVIATION 15.72 |
| Age, Customized 13-17 | 35 participants |
| Age, Customized 18-24 | 27 participants |
| Age, Customized >24 | 152 participants |
| Age, Customized <=7 years | 28 participants |
| Age, Customized 8 - 12 | 21 participants |
| Region of Enrollment Austria | 4 participants |
| Region of Enrollment Belgium | 20 participants |
| Region of Enrollment Czechia | 9 participants |
| Region of Enrollment Denmark | 28 participants |
| Region of Enrollment France | 22 participants |
| Region of Enrollment Hungary | 17 participants |
| Region of Enrollment Israel | 14 participants |
| Region of Enrollment Italy | 18 participants |
| Region of Enrollment Lithuania | 14 participants |
| Region of Enrollment Poland | 39 participants |
| Region of Enrollment Serbia | 20 participants |
| Region of Enrollment Slovakia | 4 participants |
| Region of Enrollment Slovenia | 20 participants |
| Region of Enrollment Spain | 22 participants |
| Region of Enrollment Sweden | 12 participants |
| Sex: Female, Male Female | 164 Participants |
| Sex: Female, Male Male | 99 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 24 / 263 |
Outcome results
Primary
Frequency as Percentage of Sensor Usage
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
Time frame: every 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Whole Population | Frequency as Percentage of Sensor Usage | Baseline - 3 months | 37 % of time | Standard Deviation 29 |
| Whole Population | Frequency as Percentage of Sensor Usage | 3 months - 6 months | 31 % of time | Standard Deviation 28 |
| Whole Population | Frequency as Percentage of Sensor Usage | 6 months - 9 months | 28 % of time | Standard Deviation 28 |
| Whole Population | Frequency as Percentage of Sensor Usage | 9 months - 12 months | 27 % of time | Standard Deviation 28 |
| Whole Population | Frequency as Percentage of Sensor Usage | baseline - 12 months | 30 % of time | Standard Deviation 26 |
Primary
HbA1c
Time frame: every 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Whole Population | HbA1c | Baseline | 8.1 percent | Standard Deviation 1.4 |
| Whole Population | HbA1c | 3Months | 7.87 percent | Standard Deviation 1.2 |
| Whole Population | HbA1c | 6Months | 7.9 percent | Standard Deviation 1.17 |
| Whole Population | HbA1c | 9Months | 7.98 percent | Standard Deviation 1.14 |
| Whole Population | HbA1c | 12Months | 8.05 percent | Standard Deviation 1.23 |
Primary
Percentage of Patients Achieving HbA1c < 7%
Time frame: every 3 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Whole Population | Percentage of Patients Achieving HbA1c < 7% | Baseline | 18.25 percent of patients |
| Whole Population | Percentage of Patients Achieving HbA1c < 7% | 3 months | 18.5 percent of patients |
| Whole Population | Percentage of Patients Achieving HbA1c < 7% | 6 months | 18.22 percent of patients |
| Whole Population | Percentage of Patients Achieving HbA1c < 7% | 9 months | 17.72 percent of patients |
| Whole Population | Percentage of Patients Achieving HbA1c < 7% | 12 months | 16.02 percent of patients |
Primary
Percentage of Patients Achieving HbA1c < 7.5%
Time frame: every 3 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Whole Population | Percentage of Patients Achieving HbA1c < 7.5% | Baseline | 28.52 percent of patients |
| Whole Population | Percentage of Patients Achieving HbA1c < 7.5% | 3 months | 36.22 percent of patients |
| Whole Population | Percentage of Patients Achieving HbA1c < 7.5% | 6 months | 32.79 percent of patients |
| Whole Population | Percentage of Patients Achieving HbA1c < 7.5% | 9 months | 31.65 percent of patients |
| Whole Population | Percentage of Patients Achieving HbA1c < 7.5% | 12 months | 33.33 percent of patients |
Secondary
Diabetes Treatment Satisfaction Questionnaire Status Version (DTSQs)
A 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.
Time frame: at baseline, after 3 and after 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Whole Population | Diabetes Treatment Satisfaction Questionnaire Status Version (DTSQs) | Perceived Frequency Hyperglycaemia at 3Months | 2.67 score | Standard Deviation 1.17 |
| Whole Population | Diabetes Treatment Satisfaction Questionnaire Status Version (DTSQs) | Diatbetes Treatment satisfaction score at baseline | 31.42 score | Standard Deviation 3.15 |
| Whole Population | Diabetes Treatment Satisfaction Questionnaire Status Version (DTSQs) | Treatment satisfaction score at 3Months | 30.80 score | Standard Deviation 4.33 |
| Whole Population | Diabetes Treatment Satisfaction Questionnaire Status Version (DTSQs) | Treatment satisafaction score at 12Months | 32 score | Standard Deviation 3.29 |
| Whole Population | Diabetes Treatment Satisfaction Questionnaire Status Version (DTSQs) | Perceived Frequency Hypoglycaemia at baseline | 2.18 score | Standard Deviation 1.28 |
| Whole Population | Diabetes Treatment Satisfaction Questionnaire Status Version (DTSQs) | Perceived Frequency Hypoglycaemia at 3Months | 2.5 score | Standard Deviation 1.32 |
| Whole Population | Diabetes Treatment Satisfaction Questionnaire Status Version (DTSQs) | Perceived Frequency Hypoglycaemia at 12Months | 2.03 score | Standard Deviation 1.16 |
| Whole Population | Diabetes Treatment Satisfaction Questionnaire Status Version (DTSQs) | Perceived Frequency Hyperglycaemia at baseline | 2.83 score | Standard Deviation 1.3 |
| Whole Population | Diabetes Treatment Satisfaction Questionnaire Status Version (DTSQs) | Perceived Frequency Hyperglycaemia at 12Months | 2.35 score | Standard Deviation 1.33 |
Secondary
Fear of Hypoglycemia Survey (HFS-II) - Total Score and Behavior Score
sub-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.
Time frame: at baseline, after 6 and after 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Whole Population | Fear of Hypoglycemia Survey (HFS-II) - Total Score and Behavior Score | Total score at baseline | 37 Score | Standard Deviation 25.94 |
| Whole Population | Fear of Hypoglycemia Survey (HFS-II) - Total Score and Behavior Score | Total score at 6Months | 32.74 Score | Standard Deviation 21.24 |
| Whole Population | Fear of Hypoglycemia Survey (HFS-II) - Total Score and Behavior Score | Total score at 12Months | 28.95 Score | Standard Deviation 20.11 |
| Whole Population | Fear of Hypoglycemia Survey (HFS-II) - Total Score and Behavior Score | Behavior Score at baseline | 16.03 Score | Standard Deviation 10.71 |
| Whole Population | Fear of Hypoglycemia Survey (HFS-II) - Total Score and Behavior Score | Behavior score at 6Months | 14.56 Score | Standard Deviation 9.06 |
| Whole Population | Fear of Hypoglycemia Survey (HFS-II) - Total Score and Behavior Score | Behavior score at 12Months | 13.35 Score | Standard Deviation 8.81 |
Secondary
Fear of Hypoglycemia Survey (HFS-II) - Worry Score
sub-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.
Time frame: at baseline, after 6 and after 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Whole Population | Fear of Hypoglycemia Survey (HFS-II) - Worry Score | Worry score at baseline | 23.39 Score | Standard Deviation 15.65 |
| Whole Population | Fear of Hypoglycemia Survey (HFS-II) - Worry Score | Worry score at 6Months | 20.65 Score | Standard Deviation 15.37 |
| Whole Population | Fear of Hypoglycemia Survey (HFS-II) - Worry Score | Worry score at 12Months | 18.40 Score | Standard Deviation 14.84 |