Type 1 DiabetesNCT01519466

Impact of a built-in Insulin Calculator Feature on Diabetes Control - Pilot Study

A study testing FreeStyle InsuLinx and FreeStyle Freedom Lite in people with Type 1 Diabetes, run by Abbott Diabetes Care at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to investigate the effect of using FreeStyle InsuLinx (a blood glucose meter with a built-in insulin calculator) on glucose control in people with type 1 diabetes. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 1 Diabetes
What is being tested?: FreeStyle InsuLinx and FreeStyle Freedom Lite
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 55 participants
Where: 4 sitesin 2 countries
Study dates: Jan 2012to Oct 2012
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

Subject with Type 1 diabetes on MDI (3 or more insulin injections per day (U100 insulin)) for at least 1 year and insulin adjusting
HbA1c between 7.0% and 9.5% (53 to 80 mmol/mol) inclusive
Age 18 and over
In the investigator's opinion, thought technically capable of using masked CGM
Subject self reporting a minimum of 21 SMBG tests per week prior to study enrolment
Willing to perform a minimum of 4 SMBG tests per day during study

Who cannot join

Subject has any concomitant disease or condition that, in the investigator's opinion, may compromise patient safety
Subject is participating in another study of a glucose monitoring device / drug that could affect glucose measurements / management
Subject is pregnant / planning to become pregnant within the planned study timeline
Subject is known to require a dose of more than 50 units of U100 insulin in any one bolus injection
Subject is currently on an insulin pump
Subject is currently using the FreeStyle InsuLinx

Show all 9Show fewer

Subject is currently using the FreeStyle Freedom Lite
Subject is currently using CGM
Subject has an allergy to medical grade adhesives

Trial locations and contacts

4 sites in 2 countries.

Country

City, postcode or hospital

4 sites in 2 countries

Germany3 sites

Diabetes Zentrum Mergentheim
Bad Mergentheim, 97980
Diabetes-Zentrum für Kinder und Jugendliche
Hanover, 30173
Institut für Diabetes - Technology Forschungs - und Entwicklungsgesellschaft mbH an der Universität Ulm
Ulm, D-89081

Other trials in Germany

Netherlands1 site

VU University Medical Centre (VUMC)
Amsterdam, 1007 MB

Other trials in Netherlands

About this study

The purpose of this study is to investigate the effect of using FreeStyle InsuLinx (a blood glucose meter with a built-in insulin calculator) on glucose control in people with type 1 diabetes.

Conditions: Type 1 Diabetes
Being tested: FreeStyle InsuLinx, FreeStyle Freedom Lite
Keywords: Diabetes, SMBG, Insulin calculator
Medical subject headings: Diabetes Mellitus, Type 1, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FreeStyle InsuLinxDevice
FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature.
FreeStyle Freedom LiteDevice
FreeStyle Freedom Lite is a blood glucose meter

Study groups in NCT01519466
Study group	Role	What they receive
Intervention	Other	Subjects will use a FreeStyle InsuLinx blood glucose meter during the study Receives: Device: FreeStyle InsuLinx
Control	Other	Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study. Receives: Device: FreeStyle Freedom Lite

What is being measured

The primary outcome is the main question the study is designed to answer.

Time in Target Blood Glucose Range
Masked continuous glucose monitoring data will be collected for two weeks at the start of the study and 2 weeks at the end of the study. Analysis will assess the difference between the assessment and baseline phase for the intervention group. Target blood glucose range is 3.9 to 10.0mmol/l (70 to 180mg/dL)
Measured: Day 1-15 compared with Day 60-74

Secondary outcomes (2)

HbA1c
HbA1c will be tested at baseline (day 1) and then again at end of study (approximately day 74).
The percentage of glycosylated hemoglobin in Diabetes Control and Complications Trial (DCCT) units was standardized to the newer International Federation of Clinical Chemistry (IFCC) units (mmol/mol).
Measured: Day 1 compared with Day 74
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 60.
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 (-3 to +3). 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 satisfaction with perceived frequency of Hypoglycaemia and one question to assess change satisfaction with perceived frequency of Hyperglycaemia. Each question is rated on a 7-point Likert scale (-3 to +3), -3 (much less satisfied) to +3 (much more satisfied).
The 95% confidence intervals for the FreeStyle InsuLinx group DTSQc scores was calculated using a one-sample t-test.
Measured: Day 60 compared to day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2012Oct 2012

First posted27 Jan 2012 (estimated)
Study startJan 2012
Primary completionOct 2012
Study completionOct 2012

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 Type 1 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: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01519466
Sponsor's protocol ID: ADC-PMR-INX-11012
Status last verified: Mar 2016
First submitted: 6 Jan 2012
Last updated: 1 Apr 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia

All Type 1 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of a built-in Insulin Calculator Feature on Diabetes Control - Pilot Study
ClinicalTrials.gov ID: NCT01519466
Acronym / sponsor ID: ADC-PMR-INX-11012
Conditions: Type 1 Diabetes
Keywords: Diabetes, SMBG, Insulin calculator
Study type: Interventional
Recruitment status: Completed
Enrolment: 55 participants (actual)
Lead sponsor: Abbott Diabetes CareIndustry (pharma, biotech, devices)
Study start: Jan 2012
Primary completion: Oct 2012 (actual)
Study completion: Oct 2012 (actual)
First posted: 27 Jan 2012 (estimated)
Results: Posted 1 Apr 2016

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 investigate the effect of using FreeStyle InsuLinx (a blood glucose meter with a built-in insulin calculator) on glucose control in people with type 1 diabetes.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Intervention	Other	Device: FreeStyle InsuLinxSubjects will use a FreeStyle InsuLinx blood glucose meter during the study
Control	Other	Device: FreeStyle Freedom LiteSubjects will use a FreeStyle Freedom Lite blood glucose meter during the study.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Subject with Type 1 diabetes on MDI (3 or more insulin injections per day (U100 insulin)) for at least 1 year and insulin adjusting
HbA1c between 7.0% and 9.5% (53 to 80 mmol/mol) inclusive
Age 18 and over
In the investigator's opinion, thought technically capable of using masked CGM
Subject self reporting a minimum of 21 SMBG tests per week prior to study enrolment

Key exclusion criteria (9 listed)

Subject has any concomitant disease or condition that, in the investigator's opinion, may compromise patient safety
Subject is participating in another study of a glucose monitoring device / drug that could affect glucose measurements / management
Subject is pregnant / planning to become pregnant within the planned study timeline
Subject is known to require a dose of more than 50 units of U100 insulin in any one bolus injection
Subject is currently on an insulin pump

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
FreeStyle InsuLinxFreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature.	Device	Intervention
FreeStyle Freedom LiteFreeStyle Freedom Lite is a blood glucose meter	Device	Control

Primary outcome

Time in Target Blood Glucose Range
Time frame: Day 1-15 compared with Day 60-74
Masked continuous glucose monitoring data will be collected for two weeks at the start of the study and 2 weeks at the end of the study. Analysis will assess the difference between the assessment and baseline phase for the intervention group. Target blood glucose range is 3.9 to 10.0mmol/l (70 to 180mg/dL)

2 secondary outcomes

HbA1c
Time frame: Day 1 compared with Day 74
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 60.
Time frame: Day 60 compared to day 1

Results and safety

Results posted to the registry on 1 Apr 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
FreeStyle InsuLinx	33	33
FreeStyle Freedom Lite	16	16

Primary outcome: Time in Target Blood Glucose Range

Time frame: Day 1-15 compared with Day 60-74. Mean (Standard Deviation). Unit: hours per day

Measure	FreeStyle InsuLinx n = 32	FreeStyle Freedom Lite n = 16
Baseline	15.28 (2.76)	15.31 (3.15)
Final	14.56 (2.99)	14.14 (2.36)

FreeStyle InsuLinx: Mean Difference (Final Values): -0.71 (95% CI -1.55 to 0.12), p = 0.0926, t-test, 2 sided
FreeStyle Freedom Lite: Mean Difference (Final Values): -1.17

Population analysed: One FreeStyle InsuLinx group subject was excluded from the analysis due to a protocol deviation.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events collected from enrolment to completion by last subject (up to 3 months).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FreeStyle InsuLinx	3 of 33 (9.1%)	8 of 33 (24.2%)	Not reported
FreeStyle Freedom Lite	2 of 16 (12.5%)	4 of 16 (25%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Type 1 Diabetes

Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia

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.

Prof. Michaela Diamant principal investigator

VU University Medical Centre (VUMC)

4 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing FreeStyle InsuLinx and FreeStyle Freedom Lite in people with Type 1 Diabetes, run by Abbott Diabetes Care at 4 sites in 2 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 9 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 1 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Germany, Netherlands. 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 1 Apr 2016). 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 in Target Blood Glucose Range (time frame: Day 1-15 compared with Day 60-74). 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 NCT01519466.

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 1 Apr 2016.