Automated Insulin Delivery in Type 1 Diabetes Complicated by Gastroparesis
NCT ID: NCT05795309
Last Updated: 2023-09-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
16 participants
INTERVENTIONAL
2023-08-16
2024-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Hybrid Automated Insulin Delivery
The intervention is the Medtronic 780G Hybrid Automated Insulin Delivery system
Hybrid Automated Insulin Delivery
Consists of an insulin pump and real-time continuous glucose monitoring (CGM)
Standard care
The control is Standard Care with real-time CGM
No interventions assigned to this group
Interventions
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Hybrid Automated Insulin Delivery
Consists of an insulin pump and real-time continuous glucose monitoring (CGM)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Imperial College London
OTHER
Responsible Party
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Principal Investigators
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Nick Oliver
Role: PRINCIPAL_INVESTIGATOR
Imperial College London
Locations
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Imperial College London and Imperial College Healthcare NHS Trust
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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22HH8008
Identifier Type: -
Identifier Source: org_study_id
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