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

September 8, 2023 updated by: Imperial College London
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Medtronic 780G
No Intervention: Standard care
The control is Standard Care with real-time CGM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 - 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage time spent in hypoglycaemia (<3.0mmol/L)
Time Frame: 4 - 8 weeks
The change in percentage time in hypoglycaemia(<3.0mmol/L) between baseline and intervention/control
4 - 8 weeks
Percentage time spent in hypoglycaemia (<3.9mmol/L)
Time Frame: 4 - 8 weeks
The change in percentage time in hypoglycaemia (<3.9mmol/L) between baseline and intervention/control
4 - 8 weeks
Percentage time spent in hyperglycaemia (>10mmol/L)
Time Frame: 4 - 8 weeks
The change in percentage time in hyperglycaemia (>10mmol/L) between baseline and intervention/control
4 - 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Investigators

  • Principal Investigator: Nick Oliver, Imperial College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 16, 2023

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

March 21, 2023

First Submitted That Met QC Criteria

March 21, 2023

First Posted (Actual)

April 3, 2023

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 8, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22HH8008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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