Routine Use of Sensor-Augmented Pump Therapy - a Follow up Study

NCT01451372 | Completed Results DMC

• 1 other identifier: SW01
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to document the routine practice in continuous glucose monitoring (CGM) in patients treated with sensor-augmented pump therapy and to assess clinical outcome (HbA1c) before the start of the sensor use to the end of the follow-up period. Moreover, data on treatment satisfaction, and fear of hypoglycemia, cost of the therapy, side effects and treatment interruption will be collected.

Conditions

Diabetes

Keywords

Diabetes; CGM; CSII

Outcome Measures

Primary Outcomes (1)

• Daily Usage of Blood Glucose Test (BG Testing)

  Daily usage of blood glucose test 0-24 months after CGM usage. This information is collected in a journal questionnaire

  24 months

Secondary Outcomes (1)

• Frequency of Sensor Usage Per Month

  24 months

Eligibility Criteria

• Age: Up to 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Population will be selected from Primary Care Clinics.

You may qualify if:

• Patient (and/or legal representative) has signed Patient Informed Consent(PIC) AND
• Patient (0-69 years) was diagnosed with Type 1 DM and has been on insulin pump therapy (without any additional insulin injection) for at least 3 months prior to signature of the PIC AND
• HbA1c ≥ 7 %) or
• has experienced at least 2 severe hypoglycemic events in the last 12 months or
• is performing on average more than 10 SMBG per day AND The patient has used, or is using or will start using continuous glucose monitoring as part of the CSII therapy for at least 70% of the time for a minimum of 3 months.

You may not qualify if:

• Participation in any other clinical trial - currently and/or in the last 3 months prior signature of informed consent and/or during the retrospective period of data collection.
• Unwillingness to perform at least 4 BG tests per day
• Unwillingness to maintain contact with HCP
• For children: no reliable contact person
• PREGNANT woman and wish of pregnancy
• Vision and hearing impairment not allowing pump use
• Any disease or drug treatment that can interfere with the outcome of sensor usage.

Sponsors & Collaborators

• Medtronic Diabetes: lead

Study Sites (1)

Medtronic AB

Stockholm, Kista, 164 21, Sweden

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Suiying Huang, Statistician
• Organization: Medtronic Minimed

suiying.huang@medtronic.com

8184763319

Study Officials

• Eva Örtqvist, MD

  ALB, Karolinska Universitetssjukhuset Solna

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: September 29, 2011
• First Posted: October 13, 2011
• Study Start: June 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: December 1, 2011
• Last Updated: February 27, 2019
• Results First Posted: February 27, 2019

Record last verified: 2018-10

Locations

SE (1)