Type 1 Diabetes MellitusIMPACTNCT02232698
An Evaluation of Novel Glucose Sensing Technology on Hypoglycaemia in Type 1 Diabetes (IMPACT)
A study testing Sensor Based Glucose Monitoring System and Standard Blood Glucose Monitoring in people with Type 1 Diabetes Mellitus, run by Abbott Diabetes Care at 23 sites in 5 countries.
Trial summary
The purpose of this study is to evaluate the impact of the Abbott Sensor Based Glucose Monitoring System on hypoglycaemia compared to Self Monitoring Blood Glucose (SMBG) testing using a randomised controlled study design in adults with Type 1 diabetes using insulin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Sensor Based Glucose Monitoring System and Standard Blood Glucose Monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 328 participants
- Where
- 23 sitesin 5 countries
- Study dates
- Sep 2014to Oct 2015
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with Type 1 diabetes for ≥ 5 years
- On their current insulin regimen for ≥ 3 months prior to study entry
- Screening HbA1c result ≤ 7.5% (58 mmol/mol)
- Reports self testing of blood glucose levels on a regular basis equivalent to a minimum of 3 times daily for at least 2 months prior to study entry
- In the investigator's opinion the subject is considered technically capable of using the Abbott Sensor Based Glucose Monitoring System
- Aged 18 years or over.
Who cannot join
- Subject has been diagnosed with hypoglycaemic unawareness (i.e. subject has a diagnosis of impaired awareness of hypoglycaemia recorded in their medical notes OR in the investigator's opinion the subject currently experiences less than minimal warning symptoms for impending hypoglycaemia)
- Subject is currently prescribed animal insulin
- Subject is currently prescribed oral steroid therapy or is likely to require oral steroid therapy for any acute or chronic condition during the study
- Has known allergy to medical grade adhesives
- Currently participating in another device or drug study that could affect glucose measurements or glucose management
- Currently using a Continuous Glucose Monitoring (CGM) device or has used one within the previous 4 months
Show all 16Show fewer
- Currently using Sensor augmented pump therapy
- Is planning to use a CGM device at any time during the study
- A female subject who is pregnant or planning to become pregnant within the study duration
- A breast feeding mother
- Currently receiving dialysis treatment or planning to receive dialysis during the study
- Has a pacemaker
- Has experienced an acute myocardial infarction within previous 6 months
- Has a concomitant disease or condition that may compromise subject safety including; unstable coronary heart disease, cystic fibrosis, serious psychiatric disorder, or any other uncontrolled medical condition
- Has experienced an episode of confirmed or suspected diabetic ketoacidosis (DKA) in the previous 6 months
- In the investigator's opinion, the subject is considered unsuitable for inclusion in the study for any other reason.
Trial locations and contacts
23 sites in 5 countries.
23 sites in 5 countries
Austria6 sites
VIVIT-Institut am Akad. Lehrkrankenhaus Feldkirch, Innere Medizin und Kardiologie
Feldkirch, 6807
Medizinische Universität Graz Abteilung für Innere Medizin, Klin. Abteilung für Endokrinologie und Stoffwechsel
Graz, 8036
Medizinische Universität Innsbruck
Innsbruck, 6020
Diakonissen-Krankenhaus Salzburg
Salzburg, 5020
Klinik fuer Innere Medizin III Medizinische Universitaet Wien
Vienna, 1090
Wilhelminenspital Medzin 5
Vienna, 1160
Netherlands6 sites
Vrije Universiteit Medisch Centrum
Amsterdam, 1007 MB
Onze Lieve Vrouwe gasthuis ( OLVG)
Amsterdam, 1090 HM
Amphia Ziekenhuis
Breda, 4800 RK
Bethesda Diabetes Research Center
Hoogeveen, 7909 AA
Medisch Centrum Haaglanden
The Hague, 2512 VA
St. Antonius Ziekenhuis
Utrecht, 3543 AZ
Germany5 sites
Diabetes Klinik Bad Mergentheim
Bad Mergentheim, 97980
Zentrum für Diabetologie Hamburg Bergedorf
Hamburg, 21029
Diabetes-Zentrum Hannover-Nord
Hanover, 30165
Diabetes Center Quakenbruck
Quakenbrück, 49610
Versdias GmbH
Sūlzbach-Rosenberg, 92237
Spain3 sites
Hospital Germans Trias i Pujol
Badalona, 8916
Clinica Diabetologica
Gijón, 33206
Servicio de Endocrinología Hospital Unversitario Cruces
Vizcaya, 48903
Sweden3 sites
Falu Lasarett
Falun, SE-791 29
Karolinska Universitetssjukhuset Solna
Solna, SE-171 76
Karolinska Universitetssjukhuset Huddinge
Stockholm, SE-141 86
About this study
Official title: Randomised Controlled Study to Evaluate the Impact of Novel Glucose Sensing Technology on Hypoglycaemia in Type 1 Diabetes
The purpose of this study is to evaluate the impact of the Abbott Sensor Based Glucose Monitoring System on hypoglycaemia compared to Self Monitoring Blood Glucose (SMBG) testing using a randomised controlled study design in adults with Type 1 diabetes using insulin.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Sensor Based Glucose Monitoring System, Standard Blood Glucose Monitoring
- Keywords
- Sensing Technology, Type 1 Diabetes,
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensor Based Glucose Monitoring SystemDevice
Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).
Standard Blood Glucose MonitoringDevice
Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).
| Study group | Role | What they receive |
|---|---|---|
| Sensor Based Glucose Monitoring System | Experimental | Standard sensing system use for 6 months. Receives: Device: Sensor Based Glucose Monitoring System |
| Standard Blood Glucose Monitoring | Active comparator | Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration. Receives: Device: Standard Blood Glucose Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Spent <70 mg/dL
Difference in time <70 mg/dL between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).
Measured: Baseline and Days 194 to 208
Secondary outcomes (8)
HbA1c at 6 Months
Difference in HbA1c between intervention and control group at day 208 adjusting for baseline HbA1c at day 1
Measured: Baseline and Day 208
Time Spent <55 mg/dL and <40 mg/dL
Difference in time <55 mg/dL \& <40 mg/dL (hours per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).
Measured: Baseline and Days 194 to 208
Frequency of Episodes <70 mg/dL, <55 mg/dL and <40 mg/dL
Difference in frequency of episodes <70 mg/dL, <55 mg/dL and <40 mg/dL (number per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).
Measured: Baseline and Days 194-208
Time Spent >180 mg/dL and >240 mg/dL
Difference in time >180 mg/dL and >240 mg/dL (hours per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).
Measured: Baseline and Days 194 to 208
Time in Range
Difference in time in range 70-180 mg/dL between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15 time in range).
Measured: Baseline and Days 194 to 208
Number of Glucose Measurements Performed
Number of blood glucose fingerstick tests per day by intervention and control group during baseline (days 1 to 15) and days 194 to 208. The number of sensor scans performed performed by the intervention group during days 15 to 208.
Measured: Days 1 to 208
System Utilisation
System utilisation assessed by percentage of sensor glucose data collected by the intervention group
Measured: Days 15 to 208
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 208
The Diabetes Treatment Satisfaction Questionnaire change (DTSQc) score is used to assess relative change in participant satisfaction from baseline. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale (which ranges from -3 (much less satisfied) to +3 (much more satisfied). The scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from -18 (much less satisfied) to +18 (much more satisfied).
There is one question to assess the change in perceived frequency of Hypoglycaemia and one question to assess change in perceived frequency of Hyperglycaemia. Each question is rated on a 7-point Likert scale (-3 to +3), -3 (much less of the time now) to +3 (much more of the time now).
The ANCOVA adjusts for baseline DTSQs (status version).
Measured: Baseline and Day 208
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionOct 2015
- Study completionOct 2015
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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Diabetes Care
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephan Matthaei, Principal investigator, Diabetes Center Quakenbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02232698
- Sponsor's protocol ID
- ADC-CI-APO-13019
- Acronym
- IMPACT
- Status last verified
- Feb 2017
- First submitted
- 3 Sep 2014
- Last updated
- 10 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Oskarsson P, Antuna R, Geelhoed-Duijvestijn P, Krӧger J, Weitgasser R, Bolinder J. Impact of flash glucose monitoring on hypoglycaemia in adults with type 1 diabetes managed with multiple daily injection therapy: a pre-specified subgroup analysis of the IMPACT randomised controlled trial. Diabetologia. 2018 Mar;61(3):539-550. doi: 10.1007/s00125-017-4527-5. Epub 2017 Dec 23.
PubMed 29273897Rayman G, Kroger J, Bolinder J. Could FreeStyle Libre sensor glucose data support decisions for safe driving? Diabet Med. 2018 Apr;35(4):491-494. doi: 10.1111/dme.13515. Epub 2017 Oct 14.
PubMed 28945936Bolinder J, Antuna R, Geelhoed-Duijvestijn P, Kroger J, Weitgasser R. Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial. Lancet. 2016 Nov 5;388(10057):2254-2263. doi: 10.1016/S0140-6736(16)31535-5. Epub 2016 Sep 12.
PubMed 27634581
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Study to Evaluate the Impact of Novel Glucose Sensing Technology on Hypoglycaemia in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT02232698
- Acronym / sponsor ID
- IMPACT / ADC-CI-APO-13019
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Sensing Technology, Type 1 Diabetes,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- Abbott Diabetes CareIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 5 Sep 2014 (estimated)
- Results
- Posted 10 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the impact of the Abbott Sensor Based Glucose Monitoring System on hypoglycaemia compared to Self Monitoring Blood Glucose (SMBG) testing using a randomised controlled study design in adults with Type 1 diabetes using insulin.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sensor Based Glucose Monitoring System | Experimental | Device: Sensor Based Glucose Monitoring SystemStandard sensing system use for 6 months. |
| Standard Blood Glucose Monitoring | Active comparator | Device: Standard Blood Glucose MonitoringSubjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed with Type 1 diabetes for ≥ 5 years
- On their current insulin regimen for ≥ 3 months prior to study entry
- Screening HbA1c result ≤ 7.5% (58 mmol/mol)
- Reports self testing of blood glucose levels on a regular basis equivalent to a minimum of 3 times daily for at least 2 months prior to study entry
- In the investigator's opinion the subject is considered technically capable of using the Abbott Sensor Based Glucose Monitoring System
Key exclusion criteria (16 listed)
- Subject has been diagnosed with hypoglycaemic unawareness (i.e. subject has a diagnosis of impaired awareness of hypoglycaemia recorded in their medical notes OR in the investigator's opinion the subject currently experiences less than minimal warning symptoms for impending hypoglycaemia)
- Subject is currently prescribed animal insulin
- Subject is currently prescribed oral steroid therapy or is likely to require oral steroid therapy for any acute or chronic condition during the study
- Has known allergy to medical grade adhesives
- Currently participating in another device or drug study that could affect glucose measurements or glucose management
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensor Based Glucose Monitoring SystemSubjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time). | Device | Sensor Based Glucose Monitoring System |
| Standard Blood Glucose MonitoringSubjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time). All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time). | Device | Standard Blood Glucose Monitoring |
Primary outcome
Time Spent <70 mg/dL
Time frame: Baseline and Days 194 to 208
Difference in time <70 mg/dL between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).
8 secondary outcomes
HbA1c at 6 Months
Time frame: Baseline and Day 208
Time Spent <55 mg/dL and <40 mg/dL
Time frame: Baseline and Days 194 to 208
Frequency of Episodes <70 mg/dL, <55 mg/dL and <40 mg/dL
Time frame: Baseline and Days 194-208
Time Spent >180 mg/dL and >240 mg/dL
Time frame: Baseline and Days 194 to 208
Time in Range
Time frame: Baseline and Days 194 to 208
Number of Glucose Measurements Performed
Time frame: Days 1 to 208
System Utilisation
Time frame: Days 15 to 208
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 208
Time frame: Baseline and Day 208
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29273897Oskarsson P, Antuna R, Geelhoed-Duijvestijn P, Krӧger J, Weitgasser R, Bolinder J. Impact of flash glucose monitoring on hypoglycaemia in adults with type 1 diabetes managed with multiple daily injection therapy: a pre-specified subgroup analysis of the IMPACT randomised controlled trial. Diabetologia. 2018 Mar;61(3):539-550. doi: 10.1007/s00125-017-4527-5. Epub 2017 Dec 23.
- Derived from this study: PubMed 28945936Rayman G, Kroger J, Bolinder J. Could FreeStyle Libre sensor glucose data support decisions for safe driving? Diabet Med. 2018 Apr;35(4):491-494. doi: 10.1111/dme.13515. Epub 2017 Oct 14.
- Derived from this study: PubMed 27634581Bolinder J, Antuna R, Geelhoed-Duijvestijn P, Kroger J, Weitgasser R. Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial. Lancet. 2016 Nov 5;388(10057):2254-2263. doi: 10.1016/S0140-6736(16)31535-5. Epub 2016 Sep 12.
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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.
Stephan Matthaei principal investigator
Diabetes Center Quakenbruck
23 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensor Based Glucose Monitoring System and Standard Blood Glucose Monitoring in people with Type 1 Diabetes Mellitus, run by Abbott Diabetes Care at 23 sites in 5 countries.
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 6 inclusion and 16 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 10 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Austria, Netherlands, Germany, Spain, 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 10 Apr 2017). 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?
Time Spent <70 mg/dL (time frame: Baseline and Days 194 to 208). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02232698, which also lists 3 linked publications.
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 10 Apr 2017.