The Guardcontrol Trial: Study to Assess if Type 1 Diabetics Can Improve Using the Real-time Values of Guardian RT

NCT00111228 | Completed Results

• 1 other identifier: EU 007_022004
• Study Type: interventional
• Target: 162
• Locations: 7 countries
• Sites: 8

Brief Summary

The objective of the study is to determine whether patients with poor glycemic control can improve metabolic control using the real-time values of the Guardian® RT compared to conventional self-monitoring blood glucose finger-sticks.

Conditions

Diabetes Mellitus

Keywords

Diabetes

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1c (HbA1c) - Change From Baseline to End of 3 Month Study Period

  Hemoglobin A1c (HbA1c) - change from baseline to end of 3 month study period, calculated as A1c at 3 month - A1c at baseline

  baseline and 3 month after study

Secondary Outcomes (1)

• Average Blood Glucose - Change From Baseline to End of 3 Month Study Period, Calculated as Average Blood Glucose at 3 Month - Average Blood Glucose at Baseline

  baseline and 3 month after study

Study Arms (3)

Continuous use of the Guardian RT

EXPERIMENTAL

Continuous use of the Guardian RT group

Device: Guardian RT

Bi-weekly use of the Guardian RT (once every 2 weeks)

EXPERIMENTAL

Bi-weekly use of the Guardian RT (once every 2 weeks) group

Device: Guardian RT

Control group. SMBG monitoring

ACTIVE COMPARATOR

Control group. SMBG monitoring group

Device: SMBG only

Interventions

Guardian RT DEVICE

Bi-weekly use of the Guardian RT (once every 2 weeks); Continuous use of the Guardian RT

SMBG only DEVICE

SMBG only

Control group. SMBG monitoring

Eligibility Criteria

• Age: 8 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patient has signed Informed consent form prior to Study Entry.
• Patients have been diagnosed with type 1 diabetes mellitus (DM) at least 12 months prior to Study Entry.
• HbA1c must be 8.1% or above at study entry day (central lab value).
• Patients must perform at least two self-monitoring blood glucose finger-sticks daily.
• Patients are on intensive insulin therapy; for multiple daily injections (MDI) patients specifically, be on a schedule of a minimum of 3 injections daily.
• Patients must be using only insulin analogues or rapid-acting human insulin for their meal boluses.
• Patients are willing to undergo all study procedures.
• Patients are trained on how to adapt their insulin dose to their meals and are knowledgeable concerning how to calculate and apply corrective insulin boluses post-prandially, as well as on the influence of physical activity and other life style factors on their glycemia.
• Patients are willing to participate in a Guardian® RT product training course
• Patients understand how to adjust and administer corrective treatment.

You may not qualify if:

• Patient has hearing problems/is deaf.
• Patient has impaired vision/blindness so screen alarms cannot be recognized.
• Alcohol or drug abuse other than nicotine.
• Allergy to sensor or components of the sensor.
• Manifest psychiatric disturbances.
• Patients suffering from cancer, heart failure, kidney disease and other chronic debilitating conditions.
• Patient does not have a reliable support person.
• Patient is unwilling or unable to comply with the provisions of the protocol.
• Patient has scheduled travel on a plane in the next 3 months.
• Patient has scheduled a vacation which will occur between Visit 1 and Visit 2.
• Patient is participating in another device or drug study. Subject must have completed the follow-up phase of any previous study at least 30 days prior to enrollment in this trial. The subject may only be enrolled in this study once. Patient has already participated in the Centre Qualification Phase.

Sponsors & Collaborators

• Medtronic Diabetes: lead

Study Sites (8)

Hôpital Sud Francilien

Corbeil Esssonnes, 91106, France

Location

CH Robert Debre

Paris, 75019, France

Location

Klinik für Allgemeine Charité, CVK

Berlin, D-13353, Germany

Location

Schneider Children Centre

Petah Tikva, 49202, Israel

Location

Universita Vita-Salute OspedaleS.Raffaele

Milan, 20132, Italy

Location

University Children's Hospital

Ljubljana, SI-1525, Slovenia

Location

Huddinge University Hospital

Huddinge, SE-141 86, Sweden

Location

Royal Bournemouth Hospital

Bournemouth, Dorset BH7 7DW, United Kingdom

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

818-576-3319

Study Officials

• Dorothee Deiss, MD

  Klinik für Allgemeine Charité, CVK

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 18, 2005
• First Posted: May 19, 2005
• Study Start: October 1, 2004
• Primary Completion: May 1, 2005
• Study Completion: May 1, 2005
• Last Updated: April 1, 2019
• Results First Posted: April 1, 2019

Record last verified: 2019-01

Locations

IL (1); IT (1); DE (1); SL (1); SE (1); FR (2); GB (1)