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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01451372
Recruitment Status : Completed
First Posted : October 13, 2011
Last Update Posted : November 7, 2012
Information provided by (Responsible Party):

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.

Condition or disease

Detailed Description:

The most advanced technologies for the treatment of type 1 diabetes mellitus (T1DM) include insulin pumps for continuous subcutaneous insulin infusion (CSII) and glucose sensors allowing continuous glucose monitoring(CGM). Randomized controlled trials have shown that access to CGM can improve control in poorly-controlled patients regardless of insulin treatment therapy via reduced hyper- and hypoglycaemic excursions and improved mean HbA1c value.

The Medtronic personal CGM device is composed of a glucose sensor linked to a MiniLink REAL-Time Transmitter, which transmits data from the glucose sensor to the insulin pump. The integration of these two technologies (CSII and personal CGM) into one system is called sensor-augmented pump therapy (SAP).The devices are CE-marked and routinely used in clinical practice in the Swedish market.

Based on the clinical evidences provided, the Swedish Dental and Pharmaceutical Benefits Agency (TLV) concluded that the personal CGM when used in combination to a Medtronic insulin pump as SAP should be included in the Swedish reimbursement system. However the decision was upon specific patient indications:

Patients with two or more severe hypoglycemias/year that require help from another person or Patients with HbA1c of at least 9%, in cases where optimized insulin therapy has not been effective or Children taking at least 10 medically required plasma glucose tests (fingersticks) per 24 hours and that certain follow-up information has to be complemented and submitted to TLV before March 1st, 2012.

TLV requires follow-up information on T1 diabetes patients using SAP in Swedish clinical practice and based on the following outcome parameters:

HbA1c-level of the patients Quality of life with use of CGM Side effects and therapy interruptions. Use and costs of the therapy Frequency of hypoglycemia Therefore, this project will observe the routine practice of personal CGM utilization in combination to Medtronic insulin pumps in T1DM patients in Sweden in approximately 15 investigational centers.

The aim of this project is to reflect the daily practice in personal CGM therapy (sensor and MiniLink REAL-Time Transmitter) usage in diabetes patients treated with Medtronic insulin pumps in Sweden. Data on the HbA1c value before and up to six months use of personal CGM will be collected and information on the outcomes requested by TLV will be included in the study. The patient reported outcomes will be supplemented with patient preference data and will be estimated with a willingness-to-pay (WTP) approach.

Study Type : Observational
Actual Enrollment : 69 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Routine Use of Sensor-Augmented Pump Therapy - a Follow up Study
Study Start Date : June 2011
Actual Primary Completion Date : November 2011
Actual Study Completion Date : December 2011

Primary Outcome Measures :
  1. HbA1c [ Time Frame: 6 months ]
    To assess the glycemic control in the study population based on HbA1c

Secondary Outcome Measures :
  1. Frequency of sensor usage [ Time Frame: 6 months ]
    To assess the treatment interruption of sensor usage.

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 69 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Population will be selected from Primary Care Clinics.

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01451372

Medtronic AB
Stockholm, Kista, Sweden, 164 21
Sponsors and Collaborators
Principal Investigator: Eva Örtqvist, MD ALB, Karolinska Universitetssjukhuset Solna

Responsible Party: Medtronic Identifier: NCT01451372     History of Changes
Other Study ID Numbers: SW01
First Posted: October 13, 2011    Key Record Dates
Last Update Posted: November 7, 2012
Last Verified: November 2012

Keywords provided by Medtronic: