Automated Insulin Delivery in Type 1 Diabetes Complicated by Gastroparesis (AIDgastro)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05795309
Recruitment Status : Not yet recruiting
First Posted : April 3, 2023
Last Update Posted : April 3, 2023
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
Gastroparesis Type 1 Diabetes Device: Hybrid Automated Insulin Delivery Not Applicable

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Staggered randomised control trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Automated Insulin Delivery in Type 1 Diabetes Complicated by Gastroparesis
Estimated Study Start Date : May 1, 2023
Estimated Primary Completion Date : April 30, 2024
Estimated Study Completion Date : April 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Hybrid Automated Insulin Delivery
The intervention is the Medtronic 780G Hybrid Automated Insulin Delivery system
 Device: Hybrid Automated Insulin Delivery
Consists of an insulin pump and real-time continuous glucose monitoring (CGM)
Other Name: Medtronic 780G
No Intervention: Standard care
The control is Standard Care with real-time CGM


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. % time spent in glucose target (3.9-10mmol/L) [ Time Frame: 4 - 8 weeks ]
    The change in % time in glucose target between baseline and intervention/control


Secondary Outcome Measures :
  1. % time spent in hypoglycaemia (<3.0mmol/L) [ Time Frame: 4 - 8 weeks ]
    The change in % time in hypoglycaemia(<3.0mmol/L) between baseline and intervention/control

  2. % time spent in hypoglycaemia (<3.9mmol/L) [ Time Frame: 4 - 8 weeks ]
    The change in % time in hypoglycaemia (<3.9mmol/L) between baseline and intervention/control

  3. % time spent in hyperglycaemia (>10mmol/L) [ Time Frame: 4 - 8 weeks ]
    The change in % time in hyperglycaemia (>10mmol/L) between baseline and intervention/control


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05795309


Contacts
Layout table for location contacts
Contact: Monika Reddy, PhD +44 (0)20 7594 1796 m.reddy@imperial.ac.uk
Contact: Nick Oliver, FRCP +44 (0)20 7594 1796 nick.oliver@imperial.ac.uk

Locations
Layout table for location information
United Kingdom
Imperial College London and Imperial College Healthcare NHS Trust
London, United Kingdom, W12 0HS
Contact: Monika Reddy    +44 (0)20 7594 1796    m.reddy@imperial.ac.uk   
Contact: Nick Oliver    +44 (0)20 7594 1796    nick.oliver@imerial.ac.uk   
Sponsors and Collaborators
Imperial College London
Investigators
Layout table for investigator information
Principal Investigator: Nick Oliver Imperial College London
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT05795309    
Other Study ID Numbers: 22HH8008
First Posted: April 3, 2023    Key Record Dates
Last Update Posted: April 3, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Gastroparesis
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
 Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs