Type I DiabetesAAHPINCT03653533
Evaluation of the Function "Stop Before Hypoglycemia" on External Insulin Pump
A study testing MiniMed™ 640G, Captor CGM Enlite® and SmartGuard® in people with Type I Diabetes, run by ARAIR Assistance at 1 site in France.
Trial summary
This study compares the apparition of hypoglycaemia in type I diabetic patients between 2 phases: the one without the use of SmartGuard® function and the one with the use of SmartGuard® function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type I Diabetes
- What is being tested?
- MiniMed™ 640G, Captor CGM Enlite® and SmartGuard®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jan 2019to 18 Oct 2019
- 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
- type I diabetic patients undr basal/prandial diet
- treated by insuline
- with no insuline pump during at least 3 months
- with HbA1C dosed during the 3 months before inclusion
Who cannot join
- minor patients
- pregnant woman
- already participating to another studies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Function "Stop Before Hypoglycemia" on External Insulin Pump Coupled With the Continuous Measurement of Interstitial Glycemia in Type 1 Diabetic Adults
This study compares the apparition of hypoglycaemia in type I diabetic patients between 2 phases: the one without the use of SmartGuard® function and the one with the use of SmartGuard® function.
Read the detailed description
The aim of this study is to compare SmartGuard® function with captor and insulin pump to improve the glycemia stability in real condition.
There are several phases:
- phase 1: insulin pump without captor (12 weeks)
- phase 2: insulin pump with captor and without SmartGuard® function (4X6 days; 4 weeks)
- phase 3: insulin pump with captor and with SmartGuard® function (6X6 days; 6 weeks)
- phase 4: insulin pump without captor (4 weeks)
- Conditions
- Type I Diabetes
- Being tested
- MiniMed™ 640G, Captor CGM Enlite®, SmartGuard®
- 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.
MiniMed™ 640GDevice
The MiniMed™ 640G corresponds to the medical device = pump using for the delivery of insulin
Captor CGM Enlite®Device
The Captor CGM Enlite® corresponds to the device added for the measurement of the glycemic level
SmartGuard®Device
This SmartGuard® function is used to improve the glycemia stability in real condition
| Study group | Role | What they receive |
|---|---|---|
| MiniMed™ 640G alone | Other | MiniMed™ 640G (insulin pump) is used without Captor CGM Enlite® (captor) at phase 1 and phase 4 of the study. ADDQoL, BIPQ and HADS questionnaire are performed. Receives: Device: MiniMed™ 640G |
| MiniMed™ 640G + Captor CGM Enlite® | Other | insulin pump coupled with captor without SmartGuard® function tat phase 2 of the study. ADDQoL, BIPQ and HADS questionnaire are performed. Receives: Device: MiniMed™ 640G; Device: Captor CGM Enlite® |
| MiniMed™ 640G + Captor + SmartGuard® | Other | insulin pump + captor + SmartGuard® function are used at phase 3 of the study. ADDQoL, BIPQ and HADS questionnaire are performed. Receives: Device: MiniMed™ 640G; Device: Captor CGM Enlite®; Device: SmartGuard® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of hypoglycemia between a phase with no SmartGuard® function and a phase with SmartGuard® function
The primary outcome is the area between the glycemic curve and the hypoglycemic level (70 mg/dL), measured between the 6 last days of the phase without SmartGuard® function and the 6 last days with the use of SmartGuard® function
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start7 Jan 2019
- Primary completion18 Oct 2019
- Study completion18 Oct 2019
Why it stopped: Difficulties for recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type I 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- ARAIR Assistance
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03653533
- Sponsor's protocol ID
- 2017-A01988-45
- Acronym
- AAHPI
- Status last verified
- Jul 2020
- First submitted
- 12 Jun 2018
- Last updated
- 10 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Function "Stop Before Hypoglycemia" on External Insulin Pump Coupled With the Continuous Measurement of Interstitial Glycemia in Type 1 Diabetic Adults
- ClinicalTrials.gov ID
- NCT03653533
- Acronym / sponsor ID
- AAHPI / 2017-A01988-45
- Conditions
- Type I Diabetes
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties for recruitment
- Enrolment
- 8 participants (actual)
- Lead sponsor
- ARAIR AssistanceUniversity, hospital or other
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 18 Oct 2019 (actual)
- Study completion
- 18 Oct 2019 (actual)
- First posted
- 31 Aug 2018 (actual)
- 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.
This study compares the apparition of hypoglycaemia in type I diabetic patients between 2 phases: the one without the use of SmartGuard® function and the one with the use of SmartGuard® function.
Detailed description
The aim of this study is to compare SmartGuard® function with captor and insulin pump to improve the glycemia stability in real condition.
There are several phases:
- phase 1: insulin pump without captor (12 weeks)
- phase 2: insulin pump with captor and without SmartGuard® function (4X6 days; 4 weeks)
- phase 3: insulin pump with captor and with SmartGuard® function (6X6 days; 6 weeks)
- phase 4: insulin pump without captor (4 weeks)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MiniMed™ 640G alone | Other | Device: MiniMed™ 640GMiniMed™ 640G (insulin pump) is used without Captor CGM Enlite® (captor) at phase 1 and phase 4 of the study. ADDQoL, BIPQ and HADS questionnaire are performed. |
| MiniMed™ 640G + Captor CGM Enlite® | Other | Device: MiniMed™ 640G, Device: Captor CGM Enlite®insulin pump coupled with captor without SmartGuard® function tat phase 2 of the study. ADDQoL, BIPQ and HADS questionnaire are performed. |
| MiniMed™ 640G + Captor + SmartGuard® | Other | Device: MiniMed™ 640G, Device: Captor CGM Enlite®, Device: SmartGuard®insulin pump + captor + SmartGuard® function are used at phase 3 of the study. ADDQoL, BIPQ and HADS questionnaire are performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- type I diabetic patients undr basal/prandial diet
- treated by insuline
- with no insuline pump during at least 3 months
- with HbA1C dosed during the 3 months before inclusion
Key exclusion criteria (3 listed)
- minor patients
- pregnant woman
- already participating to another studies
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 |
|---|---|---|
| MiniMed™ 640GThe MiniMed™ 640G corresponds to the medical device = pump using for the delivery of insulin | Device | MiniMed™ 640G + Captor + SmartGuard®, MiniMed™ 640G + Captor CGM Enlite®, MiniMed™ 640G alone |
| Captor CGM Enlite®The Captor CGM Enlite® corresponds to the device added for the measurement of the glycemic level | Device | MiniMed™ 640G + Captor + SmartGuard®, MiniMed™ 640G + Captor CGM Enlite® |
| SmartGuard®This SmartGuard® function is used to improve the glycemia stability in real condition | Device | MiniMed™ 640G + Captor + SmartGuard® |
Primary outcome
Occurrence of hypoglycemia between a phase with no SmartGuard® function and a phase with SmartGuard® function
Time frame: 6 days
The primary outcome is the area between the glycemic curve and the hypoglycemic level (70 mg/dL), measured between the 6 last days of the phase without SmartGuard® function and the 6 last days with the use of SmartGuard® function
Results and safety
The study was stopped early (reason given: Difficulties for recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MiniMed™ 640G, Captor CGM Enlite® and SmartGuard® in people with Type I Diabetes, run by ARAIR Assistance at 1 site in France.
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 3 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 10 Jul 2020. 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 France. 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: Difficulties for recruitment). 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?
Occurrence of hypoglycemia between a phase with no SmartGuard® function and a phase with SmartGuard® function (time frame: 6 days). 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 10 Jul 2020.