Type 2 DiabetesPhase 2NCT02490085

Closed-loop Control of Glucose Levels (Artificial Pancreas) for 24 Hours in Adults With Type 2 Diabetes Under Intensive Insulin Therapy

A Phase 2 study testing 24-hour intervention with multiple daily injections, 24-hour intervention with closed-loop strategy and Insulin in people with Type 2 Diabetes, run by Institut de Recherches Cliniques de Montreal at 2 sites in Canada.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 55 years and older
Conditions the study is for: Type 2 Diabetes
What is being tested?: 24-hour intervention with multiple daily injections, 24-hour intervention with closed-loop strategy and Insulin
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 2 sitesCanada
Study dates: Oct 2015to Sep 2018
Phase: Phase 2
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 55 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Type 2 diabetes.
Males and females ≥ 55 years of old.
Body mass index above 25 kg/m2
Non fragile defined based on Moorhouse et al. scale [23].
Using at least 3 insulin injections per day. However, basal insulin injection must be injected at bedtime without injection of basal insulin in the morning. Combination with any other anti-diabetic therapy is acceptable as long at this therapy was introduced at least 6 weeks prior the 1s intervention and is kept stable all along the protocol.
HbA1c above 6%.

Who cannot join

Advanced
Nephropathy defined by creatinine clearance <30 ml/min.
Retinopathy as proliferative retinopathy or recent (<3 month) eye bleeding or laser therapy. If the patient have undergone panphoto-coagulation inclusion is acceptable.
Autonomic neuropathy with clinically significant gastroparesis according to investigator evaluation.
Recent (< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
A recent (< 2 months) injury to body or limb, muscular disorder, use of any medication or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the ability to walk.

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A recent (< 2 months) infection needing IV antibiotic or hospitalization
Severe hypoglycemic episode within two weeks of screening.
Current use of glucocorticoid medication (by any route of administration except low dose stable inhaled).
Recent initiation or dose modification (<2 months) of therapy known to interfere with glucose metabolism (e.g. neuroleptics, anti-psychotics, etc.)
Known or suspected allergy to the trial products or meal contents.
Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

Institut de recherches cliniques de Montréal
Montreal, Quebec, H2W 1R7
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4

Other trials in Canada

About this study

Official title: An Open-label, Randomized, Two-way, Cross-over Multicenter Study to Assess the Efficacy of Closed-loop Strategy as Compared to Multiple Daily Injections in Regulating Glucose Levels During 24 Hours in Adults With Type 2 Diabetes Under Intensive Insulin Therapy

The introduction of insulin pump therapy in patients with type 2 diabetes using multiple daily injections and poorly controlled can be considered in order to improve glycemic control. Recent developments of continuous glucose sensors and insulin infusion pumps have motivated the research toward "closed-loop'' strategies to regulate glucose levels for patients with diabetes. In a closed-loop strategy, the pump(s) infusion rate is altered based on a computer generated recommendation that rely on continuous glucose sensor readings. This study confirmed the feasibility and potential of the closed-loop strategy to improve glycemic control while reducing the risk of hypoglycemia in patients with type 2 diabetes but did not target the population most likely to benefit from this strategy.The objective ot this study is to compare the efficacy of closed-loop strategy to multiple daily injections in regulating glucose levels for 24 hours in elderly adults with type 2 diabetes under intensive insulin therapy. The investigators hypothesize that closed-loop strategy will increase the time spent in the target range in adults with type 2 diabetes compared to multiple daily injections.

Conditions: Type 2 Diabetes
Being tested: 24-hour intervention with multiple daily injections, 24-hour intervention with closed-loop strategy, Insulin, Insulin pump Accu-Chek Combo, Dexcom G4 Platinum
Keywords: Type 2 diabetes, Closed-loop strategy, Artificial pancreas, Insulin, Elderly, Multiple daily injections, Hypoglycemia
Medical subject headings: Diabetes Mellitus, Type 2, Insulin Resistance, Hypoglycemia

What participants receive

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

24-hour intervention with multiple daily injectionsOther
Subjects will be admitted at the research clinical facility at 20:00. A cannula will be inserted into an arm or a hand vein for blood sampling purposes. The subjects will carry on with their normal insulin therapy. Two periods of walking of 15 minutes will be performed at 10:00 and 15:00. Meals will be served at 8:00, 12:00 and 17:00. The CHO content of meals will be adapted to subject's usual CHO intake. Venous blood samples (4 ml each) will be obtained for the measurement of the plasma glucose and insulin. Plasma glucagon and C-peptide will be measured every hour. Blood samples will be drawn every 20 minutes.
24-hour intervention with closed-loop strategyOther
Subjects will be admitted at the research clinical facility at 20:00. A cannula will be inserted into an arm or a hand vein for blood sampling purposes. A cartridge containing subject's usual fast acting insulin analog will be placed in the insulin pump. Closed-loop strategy will start at 21:00 until 21:00 the next day. Neither basal nor prandial insulin injections will be given. Two periods of walking of 15 minutes will be performed at 10:00 and 15:00. Meals will be served at 8:00, 12:00 and 17:00. The CHO content of meals will be adapted to subject's usual CHO intake. Venous blood samples (4 ml each) will be obtained for the measurement of the plasma glucose and insulin. Plasma glucagon and C-peptide will be measured every hour. Blood samples will be drawn every 20 minutes.
InsulinDrug
Subject's usual insulin analog will be used.
Insulin pump Accu-Chek ComboDevice
During closed-loop intervention, the Accu-Chek Combo (Roche) insulin pump will be used
Dexcom G4 PlatinumDevice
In both visits, glucose levels will be measure with the Dexcom G4 Platinum (Dexcom)

Study groups in NCT02490085
Study group	Role	What they receive
Multiple daily injections	Active comparator	Subjects will use multiple daily injections to regulate glucose levels. Subject's usual insulin analog will be used. Receives: Other: 24-hour intervention with multiple daily injections; Drug: Insulin; Device: Dexcom G4 Platinum
Closed-loop strategy	Active comparator	Variable subcutaneous insulin infusion rates will be used to regulate glucose levels. Subject's usual fast-acting insulin analog will be infused using a subcutaneous infusion pumps (Accu-Chek Combo, Roche). The glucose level as measured by the real time sensor (Dexcom G4 Platinum, Dexcom) will be entered manually into the computer every 10 minutes. The pumps' infusion rate will then be changed manually based on the computer generated recommendation infusion rates. Receives: Other: 24-hour intervention with closed-loop strategy; Drug: Insulin; Device: Insulin pump Accu-Chek Combo; Device: Dexcom G4 Platinum

What is being measured

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

Percentage of time of plasma glucose concentrations spent in the target range
The target range is defined as between 4.0 and 10.0 mmol/L 2-hour postprandial and between 4.0 to 8.0 mmol/L otherwise.
Measured: 24 hours

Secondary outcomes (25)

Percentage of time of plasma glucose levels spent between 4.0 to 10.0 mmol/L
Measured: 24 hours
Percentage of time of plasma glucose levels spent below 4.0 mmol/L
Measured: 24 hours
Percentage of time of plasma glucose levels spent below 3.5 mmol/L
Measured: 24 hours
Percentage of time of plasma glucose levels spent above 8.0 mmol/L
Measured: 24 hours
Percentage of time of plasma glucose levels spent above 10.0 mmol/L
Measured: 24 hours
Percentage of time of overnight plasma glucose levels spent below 4.0 mmol/L
Measured: 8 hours
Percentage of time of overnight plasma glucose levels spent between 4.0 and 8.0 mmol/L
Measured: 8 hours
Percentage of time of overnight plasma glucose levels spent between 4.0 and 10.0 mmol/L
Measured: 8 hours
Percentage of time of overnight plasma glucose levels spent below 3.5 mmol/L
Measured: 8 hours
Percentage of time of overnight plasma glucose levels above 8.0 mmol/L
Measured: 8 hours
Percentage of time of overnight plasma glucose levels above 10.0 mmol/L
Measured: 8 hours
Area under the curve of plasma glucose levels below 4.0 mmol/L
Measured: 24 hours
Area under the curve of plasma glucose levels below 3.5 mmol/L
Measured: 24 hours
Area under the curve of plasma glucose levels above 8.0 mmol/L
Measured: 24 hours
Area under the curve of plasma glucose levels above 10.0 mmol/L
Measured: 24 hours
Area under the curve of overnight plasma glucose levels below 4.0 mmol/L
Measured: 8 hours
Area under the curve of overnight plasma glucose levels below 3.5 mmol/L
Measured: 8 hours
Area under the curve of overnight plasma glucose levels above 8.0 mmol/L
Measured: 8 hours
Area under the curve of overnight plasma glucose levels above 10.0 mmol/L
Measured: 8 hours
Mean glucose levels
Measured: 24 hours
Total insulin delivery
Measured: 24 hours
Standard deviation of plasma glucose concentrations
Measured: 24 hours
Coefficient of variance of plasma glucose concentrations
Measured: 24 hours
Number of patients experiencing at least one hypoglycemic event requiring treatment
Measured: 24 hours
Number of patients experiencing at least one hypoglycemic event requiring treatment
Measured: 8 hours

Timeline

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

Oct 2015Sep 2018

First posted3 Jul 2015 (estimated)
Study startOct 2015
Primary completionSep 2018
Study completionSep 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Type 2 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02490085
Sponsor's protocol ID: CLASS-12
Status last verified: Jun 2019
First submitted: 1 Jul 2015
Last updated: 11 Jun 2019
Results posted: No
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?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Randomized, Two-way, Cross-over Multicenter Study to Assess the Efficacy of Closed-loop Strategy as Compared to Multiple Daily Injections in Regulating Glucose Levels During 24 Hours in Adults With Type 2 Diabetes Under Intensive Insulin Therapy
ClinicalTrials.gov ID: NCT02490085
Acronym / sponsor ID: CLASS-12
Conditions: Type 2 Diabetes
Keywords: Type 2 diabetes, Closed-loop strategy, Artificial pancreas, Insulin, Elderly, Multiple daily injections, Hypoglycemia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Institut de Recherches Cliniques de MontrealUniversity, hospital or other
Collaborators: Réseau de recherche en santé cardiométabolique, diabète et obésité
Study start: Oct 2015
Primary completion: Sep 2018 (actual)
Study completion: Sep 2018 (actual)
First posted: 3 Jul 2015 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Multiple daily injections	Active comparator	Other: 24-hour intervention with multiple daily injections, Drug: Insulin, Device: Dexcom G4 PlatinumSubjects will use multiple daily injections to regulate glucose levels. Subject's usual insulin analog will be used.
Closed-loop strategy	Active comparator	Other: 24-hour intervention with closed-loop strategy, Drug: Insulin, Device: Insulin pump Accu-Chek Combo, Device: Dexcom G4 PlatinumVariable subcutaneous insulin infusion rates will be used to regulate glucose levels. Subject's usual fast-acting insulin analog will be infused using a subcutaneous infusion pumps (Accu-Chek Combo, Roche). The glucose level as measured by the real time sensor (Dexcom G4 Platinum, Dexcom) will be entered manually into the computer every 10 minutes. The pumps' infusion rate will then be changed manually based on the computer generated recommendation infusion rates.

Who may qualify

Ages: 55 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Type 2 diabetes.
Males and females ≥ 55 years of old.
Body mass index above 25 kg/m2
Non fragile defined based on Moorhouse et al. scale [23].
Using at least 3 insulin injections per day. However, basal insulin injection must be injected at bedtime without injection of basal insulin in the morning. Combination with any other anti-diabetic therapy is acceptable as long at this therapy was introduced at least 6 weeks prior the 1s intervention and is kept stable all along the protocol.

Key exclusion criteria (12 listed)

Advanced
Recent (< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
A recent (< 2 months) injury to body or limb, muscular disorder, use of any medication or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the ability to walk.
A recent (< 2 months) infection needing IV antibiotic or hospitalization
Severe hypoglycemic episode within two weeks of screening.

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
24-hour intervention with multiple daily injectionsSubjects will be admitted at the research clinical facility at 20:00. A cannula will be inserted into an arm or a hand vein for blood sampling purposes. The subjects will carry on with their normal insulin therapy. Two periods of walking of 15 minutes will be performed at 10:00 and 15:00. Meals will be served at 8:00, 12:00 and 17:00. The CHO content of meals will be adapted to subject's usual CHO intake. Venous blood samples (4 ml each) will be obtained for the measurement of the plasma glucose and insulin. Plasma glucagon and C-peptide will be measured every hour. Blood samples will be drawn every 20 minutes.	Other	Multiple daily injections
24-hour intervention with closed-loop strategySubjects will be admitted at the research clinical facility at 20:00. A cannula will be inserted into an arm or a hand vein for blood sampling purposes. A cartridge containing subject's usual fast acting insulin analog will be placed in the insulin pump. Closed-loop strategy will start at 21:00 until 21:00 the next day. Neither basal nor prandial insulin injections will be given. Two periods of walking of 15 minutes will be performed at 10:00 and 15:00. Meals will be served at 8:00, 12:00 and 17:00. The CHO content of meals will be adapted to subject's usual CHO intake. Venous blood samples (4 ml each) will be obtained for the measurement of the plasma glucose and insulin. Plasma glucagon and C-peptide will be measured every hour. Blood samples will be drawn every 20 minutes.	Other	Closed-loop strategy
InsulinSubject's usual insulin analog will be used.	Drug	Closed-loop strategy, Multiple daily injections
Insulin pump Accu-Chek ComboDuring closed-loop intervention, the Accu-Chek Combo (Roche) insulin pump will be used	Device	Closed-loop strategy
Dexcom G4 PlatinumIn both visits, glucose levels will be measure with the Dexcom G4 Platinum (Dexcom)	Device	Closed-loop strategy, Multiple daily injections

Primary outcome

Percentage of time of plasma glucose concentrations spent in the target range
Time frame: 24 hours
The target range is defined as between 4.0 and 10.0 mmol/L 2-hour postprandial and between 4.0 to 8.0 mmol/L otherwise.

25 secondary outcomes

Percentage of time of plasma glucose levels spent between 4.0 to 10.0 mmol/L
Time frame: 24 hours
Percentage of time of plasma glucose levels spent below 4.0 mmol/L
Time frame: 24 hours
Percentage of time of plasma glucose levels spent below 3.5 mmol/L
Time frame: 24 hours
Percentage of time of plasma glucose levels spent above 8.0 mmol/L
Time frame: 24 hours
Percentage of time of plasma glucose levels spent above 10.0 mmol/L
Time frame: 24 hours
Percentage of time of overnight plasma glucose levels spent below 4.0 mmol/L
Time frame: 8 hours
Percentage of time of overnight plasma glucose levels spent between 4.0 and 8.0 mmol/L
Time frame: 8 hours
Percentage of time of overnight plasma glucose levels spent between 4.0 and 10.0 mmol/L
Time frame: 8 hours
Percentage of time of overnight plasma glucose levels spent below 3.5 mmol/L
Time frame: 8 hours
Percentage of time of overnight plasma glucose levels above 8.0 mmol/L
Time frame: 8 hours
Percentage of time of overnight plasma glucose levels above 10.0 mmol/L
Time frame: 8 hours
Area under the curve of plasma glucose levels below 4.0 mmol/L
Time frame: 24 hours
Area under the curve of plasma glucose levels below 3.5 mmol/L
Time frame: 24 hours
Area under the curve of plasma glucose levels above 8.0 mmol/L
Time frame: 24 hours
Area under the curve of plasma glucose levels above 10.0 mmol/L
Time frame: 24 hours
Area under the curve of overnight plasma glucose levels below 4.0 mmol/L
Time frame: 8 hours
Area under the curve of overnight plasma glucose levels below 3.5 mmol/L
Time frame: 8 hours
Area under the curve of overnight plasma glucose levels above 8.0 mmol/L
Time frame: 8 hours
Area under the curve of overnight plasma glucose levels above 10.0 mmol/L
Time frame: 8 hours
Mean glucose levels
Time frame: 24 hours
Total insulin delivery
Time frame: 24 hours
Standard deviation of plasma glucose concentrations
Time frame: 24 hours
Coefficient of variance of plasma glucose concentrations
Time frame: 24 hours
Number of patients experiencing at least one hypoglycemic event requiring treatment
Time frame: 24 hours
Number of patients experiencing at least one hypoglycemic event requiring treatment
Time frame: 8 hours

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2019.

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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.

Rémi Rabasa-Lhoret principal investigator

Institut de Recherches Cliniques de Montreal

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 12 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 11 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 of plasma glucose concentrations spent in the target range (time frame: 24 hours). 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 NCT02490085.

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 11 Jun 2019.