DiabetesNCT01451372
Routine Use of Sensor-Augmented Pump Therapy - a Follow up Study
An observational study of Diabetes, run by Medtronic MiniMed, Inc. at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 69 years
- Conditions the study is for
- Diabetes
- How many people
- 69 participants
- Where
- 1 siteSweden
- Study dates
- Jun 2011to Dec 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 69 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Population will be selected from Primary Care Clinics.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Diabetes
- Keywords
- Diabetes, CGM, CSII
- Medical subject headings
- Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
Secondary outcomes (1)
Frequency of Sensor Usage Per Month
Frequency of sensor usage per month during the study. This information is collected in a journal questionnaire
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2011 (estimated)
- Study startJun 2011
- Primary completionNov 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic MiniMed, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eva Örtqvist, MD, Principal investigator, ALB, Karolinska Universitetssjukhuset Solna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01451372
- Sponsor's protocol ID
- SW01
- Status last verified
- Oct 2018
- First submitted
- 29 Sep 2011
- Last updated
- 27 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Routine Use of Sensor-Augmented Pump Therapy - a Follow up Study
- ClinicalTrials.gov ID
- NCT01451372
- Acronym / sponsor ID
- SW01
- Conditions
- Diabetes
- Keywords
- Diabetes, CGM, CSII
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Medtronic MiniMed, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 13 Oct 2011 (estimated)
- Results
- Posted 27 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- Up to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Population will be selected from Primary Care Clinics.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Daily Usage of Blood Glucose Test (BG Testing)
Time frame: 24 months
Daily usage of blood glucose test 0-24 months after CGM usage. This information is collected in a journal questionnaire
1 secondary outcome
Frequency of Sensor Usage Per Month
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Örtqvist, MD principal investigator
ALB, Karolinska Universitetssjukhuset Solna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by Medtronic MiniMed, Inc. at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily Usage of Blood Glucose Test (BG Testing) (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2019.