Registry of Use and Application of Sensor Augmented Pump (SAP) Therapy Under Daily Life Conditions

The Application and Advantage of Sensor Augmented Pump (SAP) Therapy Under Daily Conditions (Registerstudie Zur Anwendung Und Nutzen Der Sensorunterstützten Pumpentherapie (SuP) Unter Alltagsbedingungen)(RANSuP)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01718522

Acronym

RANSuP

Enrollment

Registered

2012-10-31

Start date

2012-02-29

Completion date

2014-01-31

Last updated

2019-01-29

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

Conditions

Diabetes Mellitus, Type 1

Brief summary

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.

Detailed description

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: * obtain reimbursement for SAP therapy in Germany * building a platform (advisory committee) for discussion of SAP data. * looking for deficits with implementation of glucose sensor data in diabetes therapy management and development of follow-up education materials. 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.

Interventions

DEVICEsensor augmented pump (SAP)

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Years to 65 Years

Healthy volunteers

Inclusion criteria

* patients with signed informed consent * Type 1 DM and has been on insulin pump therapy for at least 3 months prior to signature of the informed consent * patients use CGM component as part as part of the continuous subcutaneous insulin infusion (CSII) therapy for a minimum of 1 month

Exclusion criteria

* participation in any other trial * any disease or drug treatment that can interfere with the outcome of sensor usage * using CGM in CSII \< 3 days/week * patients not willing to sign informed consent * abuse of alcohol or drugs (exception of nicotine consumption) * eating disorder, anorexia, bulimia or other mental disorders

Design outcomes

Primary

Measure	Time frame
Number (n) of Excursions <70 mg/dl Per Sensor Day at Baseline and 3 Months	baseline and 3 months

Secondary

Measure	Time frame	Description
Hemoglobin A1c (HbA1c) Values (%) at Baseline and 3 Months	Baseline and 3 months	—
Interstitial Sensor Glucose Concentration (mg/dl) at Baseline and 3 Months	Baseline and 3 months	—
Sensor Wearing Time (Sensor Days/Calendar Week) at Baseline and 3 Months	Baseline and 3 months	—
Area Under the Curve (AUC) in Hypoglycemic Region (< 70mg/dl) at Baseline and 3 Months	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.
Number (n) of Excursions <40 mg/dl Per Sensor Day at Baseline and 3 Months	Baseline and 3 months	—
Time in Hyperglycemic Region Per Sensor Day at Baseline and 3 Months	Baseline and 3 months	—
Number of Automatic Low Glucose Suspend (LGS) Activations in Daytime (6:00 - 22:00 Hrs) at Baseline and 3 Months	Baseline and 3 months	—
Number of Automatic Low Glucose Suspend (LGS) Activations in Nighttime (22:00 - 6:00 Hrs) at Baseline and 3 Months	Baseline and 3 months	—
Interstitial Sensor Glucose Excursions After Meals (Amplitude of Excursions) at Baseline and 3 Months	Baseline and 3 months	—
Area Under the Curve (AUC) in Hyperglycemic Region (>140mg/dl) at Baseline and 3 Months	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.

Participant flow

Participants by arm

Arm	Count
Intervention Group Patients treated with sensor augmented pump (SAP) therapy with insulin pump Paradigm VEO® and use continuous glucose monitoring (CGM).	75
Total	75

Baseline characteristics

Characteristic	Intervention Group
Age, Categorical <=18 years	20 Participants
Age, Categorical >=65 years	0 Participants
Age, Categorical Between 18 and 65 years	55 Participants
Age, Continuous	33.88 years STANDARD_DEVIATION 16.56
Region of Enrollment Germany	75 participants
Sex: Female, Male Female	36 Participants
Sex: Female, Male Male	39 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 75
serious Total, serious adverse events	0 / 75

Outcome results

Primary

Number (n) of Excursions <70 mg/dl Per Sensor Day at Baseline and 3 Months

Time frame: baseline and 3 months

Arm	Measure	Group	Value (MEAN)	Dispersion
Intervention Group	Number (n) of Excursions <70 mg/dl Per Sensor Day at Baseline and 3 Months	Baseline	1.26 excursions	Standard Deviation 0.69
Intervention Group	Number (n) of Excursions <70 mg/dl Per Sensor Day at Baseline and 3 Months	3 months	0.98 excursions	Standard Deviation 0.59

p-value: 0.001t-test, 2 sided

Secondary

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.