An observational study in Diabetes Mellitus, Type 1, sponsored by Medtronic Diabetes. Completed. Open to participants aged 6 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-01-29.
Sponsored by Medtronic Diabetes · Observational
The purpose of this registry is to collect the real life data on Sensor Augmented pump (SAP) therapy usage in type 1 Diabetes mellitus (DM) patients treated with Medtronic Insulin pumps and continuous glucose monitoring systems in Germany.
The purpose of this registry is to reflect the daily practice with Sensor Augmented Pump (SAP) therapy usage in Type 1 Diabetes Mellitus (DM) patients treated with Medtronic insulin pumps (Paradigm VEO®) and continuous glucose monitoring systems in Germany. In addition, the aim is of this registry is to support:
This is a national multi-center, post-market non-interventional prospective study with CE marked and commercially available devices and consumables.
The study will be conducted from March 2012 to April 2013 in Germany. The duration of individual patient participation is 3 to 6 months.
Health outcomes will be measured in approximately 75 patients between 6-65 years old diagnosed with Type 1 DM over a period of at least 3 months in approximately 15 centers. The patients are under treatment of Paradigm VEO® without any additional insulin injections and use continuous glucose monitoring, or patients that are not using continuous glucose monitoring, but that are willing to start with SAP. The enrolled subjects have a first visit inquiring the status data (including upload of device data in CareLink software, Hemoglobin A1c (HbA1c) value measurement) without any intervention. Thereafter, the SAP therapy is optimized based on individual continuous glucose monitoring (CGM) data during a second visit one month later and then a last visit like the first visit in which the status will be determined.
Parameters of glycemic control will be measured, such as the frequency of hypoglycemia (glucose values ≤ 70 mg/dl), over a period of 30 days after the first patient's visit (Visit 1) and after the visit 2 when an adjustment of the therapy has been discussed with the patient based on the collected CGM results between the two first visits.
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 576 are open to participants now.
This study's enrollment of 75 is below the median of 120 across 748 observational studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Medtronic Diabetes is the lead sponsor of 61 studies on the registry; none are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 21 (95%) have results posted.
Counted across the registry records on this site, refreshed daily.
Diabetes mellitus, type 1
Exclusion Criteria:
Patients treated with sensor augmented pump (SAP) therapy with insulin pump Paradigm VEO® and use continuous glucose monitoring (CGM).
Device: sensor augmented pump (SAP)
Number (n) of Excursions <70 mg/dl Per Sensor Day at Baseline and 3 Months
Time frame: baseline and 3 months
Number (n) of Excursions <40 mg/dl Per Sensor Day at Baseline and 3 Months
Time frame: Baseline and 3 months
Hemoglobin A1c (HbA1c) Values (%) at Baseline and 3 Months
Time frame: Baseline and 3 months
Interstitial Sensor Glucose Concentration (mg/dl) at Baseline and 3 Months
Time frame: Baseline and 3 months
Sensor Wearing Time (Sensor Days/Calendar Week) at Baseline and 3 Months
Time frame: Baseline and 3 months
Area Under the Curve (AUC) in Hypoglycemic Region (< 70mg/dl) at Baseline and 3 Months
Area under the curve (AUC) in hypoglycemic region (\< 70mg/dl) at baseline (1 month before the start of the study) and 3 months during the study.
Time frame: Baseline and 3 months
Area Under the Curve (AUC) in Hyperglycemic Region (>140mg/dl) at Baseline and 3 Months
Area under the curve (AUC) in hyperglycemic region (\>140mg/dl) at baseline (1 month before the start of the study) and 3 months during the study.
Time frame: Baseline and 3 months
Time in Hyperglycemic Region Per Sensor Day at Baseline and 3 Months
Time frame: Baseline and 3 months
Number of Automatic Low Glucose Suspend (LGS) Activations in Daytime (6:00 - 22:00 Hrs) at Baseline and 3 Months
Time frame: Baseline and 3 months
Number of Automatic Low Glucose Suspend (LGS) Activations in Nighttime (22:00 - 6:00 Hrs) at Baseline and 3 Months
Time frame: Baseline and 3 months
Interstitial Sensor Glucose Excursions After Meals (Amplitude of Excursions) at Baseline and 3 Months
Time frame: Baseline and 3 months
| Milestone | Intervention Group |
|---|---|
| Started | 75 |
| Completed | 67 |
| Not completed | 8 |
| excursions | Intervention Group |
|---|---|
| Baseline | 1.26 ± 0.69 |
| 3 months | 0.98 ± 0.59 |
| excursions | Intervention Group |
|---|---|
| Baseline | 0.19 ± 0.22 |
| 3 months | 0.16 ± 0.21 |
| Percentage | Intervention Group |
|---|---|
| Baseline | 7.96 ± 0.93 |
| 3 months | 7.90 ± 0.97 |
| mg/dl | Intervention Group |
|---|---|
| Baseline | 154.80 ± 24.21 |
| 3 months | 159.06 ± 25.78 |
| sensor days/calendar week | Intervention Group |
|---|---|
| Baseline | 5.6 ± 1.0 |
| 3 months | 5.01 ± 1.46 |
Area under the curve (AUC) in hypoglycemic region (\< 70mg/dl) at baseline (1 month before the start of the study) and 3 months during the study.
| mg/dl*day | Intervention Group |
|---|---|
| Baseline | 0.07 ± 0.35 |
| 3 months | 0.028 ± 0.026 |
Area under the curve (AUC) in hyperglycemic region (\>140mg/dl) at baseline (1 month before the start of the study) and 3 months during the study.
| mg/dl*day | Intervention Group |
|---|---|
| Baseline | 1.32 ± 0.87 |
| 3 months | 1.79 ± 1.44 |
| min/sensor day | Intervention Group |
|---|---|
| Baseline | 737.62 ± 232.56 |
| 3 months | 771.00 ± 426.52 |
| activations/patient/sensor day | Intervention Group |
|---|---|
| Baseline | 0.62 ± 0.71 |
| 3 months | 0.73 ± 0.83 |
| activations/patient/sensor day | Intervention Group |
|---|---|
| Baseline | 0.22 ± 0.29 |
| 3 months | 0.25 ± 0.29 |
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention Group | — | 0/75 (0%) | 0/75 (0%) |
| Age, Categorical(Participants) | Intervention Group |
|---|---|
| <=18 years | 20 |
| Between 18 and 65 years | 55 |
| >=65 years | 0 |
| Age, Continuous(years) | Intervention Group |
|---|---|
| Mean | 33.88 ± 16.56 |
| Sex: Female, Male(Participants) | Intervention Group |
|---|---|
| Female | 36 |
| Male | 39 |
| Region of Enrollment(participants) | Intervention Group |
|---|---|
| Germany | 75 |
No study locations are listed for this record.
Plan to share: No
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Medtronic Diabetes