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

NCT01718522 | Completed Results FDA Device

• 1 other identifier: CEN_G_DB_1
• Study Type: observational
• Target: 75
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

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

  baseline and 3 months

Secondary Outcomes (10)

• Number (n) of Excursions <40 mg/dl Per Sensor Day at Baseline and 3 Months

  Baseline and 3 months

• 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

Study Arms (1)

Intervention Group

Patients treated with sensor augmented pump (SAP) therapy with insulin pump Paradigm VEO® and use continuous glucose monitoring (CGM).

Device: sensor augmented pump (SAP)

Interventions

sensor augmented pump (SAP) DEVICE

Intervention Group

Eligibility Criteria

• Age: 6 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Diabetes mellitus, type 1

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Diabetes: lead

Related Publications (1)

• Tsioli C, Danne T für die RANSuP-Studiengruppe. RANSuP-Registerstudie: Anwendung der Sensorunterstützten Pumpentherapie unter Alltagsbedingungen. Diabetologie und Stoffwechsel 2013; 8: S62

  RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Prof. Dr. Thomas Danne
• Organization: Kinder- und Jugendkrankenhaus Auf der Bult

danne@hka.de

0511-8115-3331

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2012
• First Posted: October 31, 2012
• Study Start: February 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: January 1, 2014
• Last Updated: January 29, 2019
• Results First Posted: January 11, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share