GastroparesisAIDgastroNCT05795309
Automated Insulin Delivery in Type 1 Diabetes Complicated by Gastroparesis
A study testing Hybrid Automated Insulin Delivery in people with Gastroparesis and Type 1 Diabetes, run by Imperial College London at 1 site in United Kingdom.
Trial summary
This is a staggered randomised controlled trial that aims to assess the impact of an automated insulin delivery (AID) system on glucose, gastrointestinal and patient-reported outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroparesis, Type 1 Diabetes
- What is being tested?
- Hybrid Automated Insulin Delivery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Aug 2023to 30 Jun 2024
- 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
- Aged 18 years of age or older
- Type 1 diabetes confirmed on the basis of clinical features
- Type 1 diabetes for greater than 1 year
- On an intensified insulin regimen with multiple dose injection or insulin pump for > 3 months
- HbA1c >7.5% (58mmol/mol) (or %TIR 3.9-10mmol/L <52% for participants already using a continuous glucose sensor)
- Gastroparesis Cardinal Symptom Index (GCSI) ≥ 18 or evidence of delayed gastric emptying on nuclear medicine gastric emptying study
Who cannot join
- Enrolled in other clinical trials
- Estimated glomerular filtration rate of ≤30ml/min
- Pregnant or planning pregnancy
- Have active malignancy or under investigation for malignancy
- Severe visual impairment
- Reduced manual dexterity
- Use of any automated insulin delivery system
- Unable to participate due to other factors, as assessed by the Chief Investigator
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Imperial College London and Imperial College Healthcare NHS Trust
London, W12 0HS
Monika Reddy, +44 (0)20 7594 1796, m.reddy@imperial.ac.uk
Nick Oliver, +44 (0)20 7594 1796, nick.oliver@imerial.ac.uk
About this study
This is a staggered randomised controlled trial that aims to assess the impact of an automated insulin delivery (AID) system on glucose, gastrointestinal and patient-reported outcomes.
Read the detailed description
Following a run-in period of 2 weeks, participants will be randomised to control or hybrid automated insulin delivery (AID) using the 780G system and will remain in the intervention phase of the study for 12 weeks (4-week control, then 4-week AID or Control and finally 4-week AID). The total duration for each participant will be 14 weeks. There are 5 study visits (combination of face to face or/and remote) and two telephone visits in total.
- Conditions
- Gastroparesis, Type 1 Diabetes
- Being tested
- Hybrid Automated Insulin Delivery
- Medical subject headings
- Gastroparesis, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid Automated Insulin DeliveryDevice
Also called Medtronic 780G
Consists of an insulin pump and real-time continuous glucose monitoring (CGM)
| Study group | Role | What they receive |
|---|---|---|
| Hybrid Automated Insulin Delivery | Experimental | The intervention is the Medtronic 780G Hybrid Automated Insulin Delivery system Receives: Device: Hybrid Automated Insulin Delivery |
| Standard care | No intervention | The control is Standard Care with real-time CGM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage time spent in glucose target (3.9-10mmol/L)
The change in percentage time in glucose target between baseline and intervention/control
Measured: 4 - 8 weeks
Secondary outcomes (3)
Percentage time spent in hypoglycaemia (<3.0mmol/L)
The change in percentage time in hypoglycaemia(<3.0mmol/L) between baseline and intervention/control
Measured: 4 - 8 weeks
Percentage time spent in hypoglycaemia (<3.9mmol/L)
The change in percentage time in hypoglycaemia (<3.9mmol/L) between baseline and intervention/control
Measured: 4 - 8 weeks
Percentage time spent in hyperglycaemia (>10mmol/L)
The change in percentage time in hyperglycaemia (>10mmol/L) between baseline and intervention/control
Measured: 4 - 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start16 Aug 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroparesisStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- Sequential
- Model description
- Staggered randomised control trial
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nick Oliver, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05795309
- Sponsor's protocol ID
- 22HH8008
- Acronym
- AIDgastro
- Status last verified
- Sep 2023
- First submitted
- 21 Mar 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Insulin Delivery in Type 1 Diabetes Complicated by Gastroparesis
- ClinicalTrials.gov ID
- NCT05795309
- Acronym / sponsor ID
- AIDgastro / 22HH8008
- Conditions
- Gastroparesis, Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 16 Aug 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 3 Apr 2023 (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 is a staggered randomised controlled trial that aims to assess the impact of an automated insulin delivery (AID) system on glucose, gastrointestinal and patient-reported outcomes.
Detailed description
Following a run-in period of 2 weeks, participants will be randomised to control or hybrid automated insulin delivery (AID) using the 780G system and will remain in the intervention phase of the study for 12 weeks (4-week control, then 4-week AID or Control and finally 4-week AID). The total duration for each participant will be 14 weeks. There are 5 study visits (combination of face to face or/and remote) and two telephone visits in total.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Staggered randomised control trial
| Arm | Type | Receives |
|---|---|---|
| Hybrid Automated Insulin Delivery | Experimental | Device: Hybrid Automated Insulin DeliveryThe intervention is the Medtronic 780G Hybrid Automated Insulin Delivery system |
| Standard care | No intervention | –The control is Standard Care with real-time CGM |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18 years of age or older
- Type 1 diabetes confirmed on the basis of clinical features
- Type 1 diabetes for greater than 1 year
- On an intensified insulin regimen with multiple dose injection or insulin pump for > 3 months
- HbA1c >7.5% (58mmol/mol) (or %TIR 3.9-10mmol/L <52% for participants already using a continuous glucose sensor)
Key exclusion criteria (8 listed)
- Enrolled in other clinical trials
- Estimated glomerular filtration rate of ≤30ml/min
- Pregnant or planning pregnancy
- Have active malignancy or under investigation for malignancy
- Severe visual impairment
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 |
|---|---|---|
| Hybrid Automated Insulin DeliveryAlso: Medtronic 780GConsists of an insulin pump and real-time continuous glucose monitoring (CGM) | Device | Hybrid Automated Insulin Delivery |
Primary outcome
Percentage time spent in glucose target (3.9-10mmol/L)
Time frame: 4 - 8 weeks
The change in percentage time in glucose target between baseline and intervention/control
3 secondary outcomes
Percentage time spent in hypoglycaemia (<3.0mmol/L)
Time frame: 4 - 8 weeks
Percentage time spent in hypoglycaemia (<3.9mmol/L)
Time frame: 4 - 8 weeks
Percentage time spent in hyperglycaemia (>10mmol/L)
Time frame: 4 - 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Individual participant dataSharing planned: No
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Recruiting
To Study the Efficacy and Safety of Medtronic 780G Insulin Pump in People With Gastroparesis and Type 1 Diabetes.
Type 1 Diabetes, Gastroparesis Due to Diabetes Mellitus Type I
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.
Nick Oliver principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid Automated Insulin Delivery in people with Gastroparesis and Type 1 Diabetes, run by Imperial College London at 1 site in United Kingdom.
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 8 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: status not confirmed, as of the sponsor's last update on 13 Sep 2023. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Monika Reddy, PhD (+44 (0)20 7594 1796, m.reddy@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage time spent in glucose target (3.9-10mmol/L) (time frame: 4 - 8 weeks). 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 13 Sep 2023.