Type 1 DiabetesNCT02162004
Continuous Correction
A study testing Continuous Correction in people with Type 1 Diabetes, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The potential of currently available diabetes technologies could be further exploited. The investigators propose that sensor-augmented insulin pump therapy may be improved by continuous correction, i.e. continuous evaluation of the need for correction boluses. 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?
- Continuous Correction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2014to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Age ≥ 18 years
- T1D ≥ 3 years
- CSII ≥ 1 year
- HbA1c ≤ 8.0% (64 mmol/mol)
Who cannot join
- Pregnancy or nursing
- Hypoglycemia unawareness
- Gastroparesis
- Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during or within 30 days prior to the study
- Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sensor-Augmented Continuous Correction in Insulin Pump-Treated Type 1 Diabetes
The potential of currently available diabetes technologies could be further exploited. The investigators propose that sensor-augmented insulin pump therapy may be improved by continuous correction, i.e. continuous evaluation of the need for correction boluses. In practice, this is carried out by running the bolus calculator every 10 minutes. The glucose sensor will provide the bolus calculator with glucose input. Many times, the bolus calculator will come to the result that no insulin is needed. However, when the blood glucose is above the pre-set target value and a correction bolus is needed, an appropriate bolus is automatically delivered by the insulin pump.
The investigators hypothesize that sensor-augmented continuous correction insulin pump therapy can reduce hyperglycemia without increasing the risk of hypoglycemia in patients with type 1 diabetes.
- Conditions
- Type 1 Diabetes
- Being tested
- Continuous Correction
- Keywords
- Type 1 diabetes, Continuous Glucose Monitoring, Insulin pump, Sensor-augmented pump, Continuous correction of high blood glucose
- 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.
Continuous CorrectionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Continuous correction | Experimental | The insulin pump is set to automatically deliver the patient's usual insulin basal rate. The insulin pump bolus calculator is run every 10 minutes by the attending physician. Bolus calculations are based on glucose sensor values. Receives: Procedure: Continuous Correction |
| Control | No intervention | Regular sensor-augmented pump therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of time CGM values are in the target range 3.9-8.0 mmol/l in the time period 8:00-17:00.
The primary outcome is difference in the percentage of time CGM values are in the target range 3.9-8.0 mmol/l in the time period 8:00-17:00 on CC-days and Control-days.
Measured: Every 5 min for 9 hours on each study day.
Secondary outcomes (7)
Mean CGM glucose value.
Measured: Every 5 min for 9 hours on each study day.
Percentage of time when CGM values are < 3.9 mmol/l.
Measured: Every 5 min for 9 hours on each study day.
Percentage of time when CGM values are > 8.0 mmol/l.
Measured: Every 5 min for 9 hours on each study day.
CGM standard deviation.
Measured: Every 5 min for 9 hours on each study day.
Number of hypoglycemic episodes.
Measured: Every 5 min for 9 hours on each study day.
Amount of insulin delivered.
Measured: Every 30 min for 9 hours on each study day.
Positive Incremental Area Under the Curve
Measured: Every 5 min for 9 hours on each study day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: Technical problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Signe Schmidt, Hvidovre University Hospital
- Investigators
- Signe Schmidt, MD, PhD, Principal investigator, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02162004
- Sponsor's protocol ID
- CC2014
- Status last verified
- Feb 2015
- First submitted
- 2 Jun 2014
- Last updated
- 31 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensor-Augmented Continuous Correction in Insulin Pump-Treated Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT02162004
- Acronym / sponsor ID
- CC2014
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 diabetes, Continuous Glucose Monitoring, Insulin pump, Sensor-augmented pump, Continuous correction of high blood glucose
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Technical problems
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 12 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The potential of currently available diabetes technologies could be further exploited. The investigators propose that sensor-augmented insulin pump therapy may be improved by continuous correction, i.e. continuous evaluation of the need for correction boluses. In practice, this is carried out by running the bolus calculator every 10 minutes. The glucose sensor will provide the bolus calculator with glucose input. Many times, the bolus calculator will come to the result that no insulin is needed. However, when the blood glucose is above the pre-set target value and a correction bolus is needed, an appropriate bolus is automatically delivered by the insulin pump.
The investigators hypothesize that sensor-augmented continuous correction insulin pump therapy can reduce hyperglycemia without increasing the risk of hypoglycemia in patients with type 1 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous correction | Experimental | Procedure: Continuous CorrectionThe insulin pump is set to automatically deliver the patient's usual insulin basal rate. The insulin pump bolus calculator is run every 10 minutes by the attending physician. Bolus calculations are based on glucose sensor values. |
| Control | No intervention | –Regular sensor-augmented pump therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- T1D ≥ 3 years
- CSII ≥ 1 year
- HbA1c ≤ 8.0% (64 mmol/mol)
Key exclusion criteria (5 listed)
- Pregnancy or nursing
- Hypoglycemia unawareness
- Gastroparesis
- Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during or within 30 days prior to the study
- Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation
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 |
|---|---|---|
| Continuous Correction | Procedure or surgery | Continuous correction |
Primary outcome
Percentage of time CGM values are in the target range 3.9-8.0 mmol/l in the time period 8:00-17:00.
Time frame: Every 5 min for 9 hours on each study day.
The primary outcome is difference in the percentage of time CGM values are in the target range 3.9-8.0 mmol/l in the time period 8:00-17:00 on CC-days and Control-days.
7 secondary outcomes
Mean CGM glucose value.
Time frame: Every 5 min for 9 hours on each study day.
Percentage of time when CGM values are < 3.9 mmol/l.
Time frame: Every 5 min for 9 hours on each study day.
Percentage of time when CGM values are > 8.0 mmol/l.
Time frame: Every 5 min for 9 hours on each study day.
CGM standard deviation.
Time frame: Every 5 min for 9 hours on each study day.
Number of hypoglycemic episodes.
Time frame: Every 5 min for 9 hours on each study day.
Amount of insulin delivered.
Time frame: Every 30 min for 9 hours on each study day.
Positive Incremental Area Under the Curve
Time frame: Every 5 min for 9 hours on each study day.
Results and safety
The study was stopped early (reason given: Technical problems). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2016.
Related trials for Type 1 Diabetes
Active, not recruitingPhase 3
Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes
Type 1 Diabetes
RecruitingObservational study
Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy
Type 1 Diabetes
Active, not recruitingPhase 1/2
A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus
Obesity
RecruitingPhase 3
A Study to Evaluate Effect of AZD6234 in Adult Participants With Obesity or Overweight With Weight-related Comorbidity Without Type 2 Diabetes Mellitus
Obesity or Overweight
Not yet recruitingPhase 1/2
Safety and Efficacy Evaluation of 4th Generation Safety-engineered CAR T Cells Targeting Sarcomas
Sarcoma, Osteoid Sarcoma
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.
Signe Schmidt, MD, PhD principal investigator
Hvidovre University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Correction in people with Type 1 Diabetes, run by Hvidovre University Hospital at 1 site in Denmark.
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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 31 Aug 2016. 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 Denmark. 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?
The study was stopped early (reason given: Technical problems). Results are not available in the source record.
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?
Percentage of time CGM values are in the target range 3.9-8.0 mmol/l in the time period 8:00-17:00. (time frame: Every 5 min for 9 hours on each study day.). 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 31 Aug 2016.