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

Primary Purpose

Gastroparesis, Type 1 Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Hybrid Automated Insulin Delivery
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroparesis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Imperial College London and Imperial College Healthcare NHS TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Hybrid Automated Insulin Delivery

Standard care

Arm Description

The intervention is the Medtronic 780G Hybrid Automated Insulin Delivery system

The control is Standard Care with real-time CGM

Outcomes

Primary Outcome Measures

Percentage time spent in glucose target (3.9-10mmol/L)
The change in percentage time in glucose target between baseline and intervention/control

Secondary Outcome Measures

Percentage time spent in hypoglycaemia (<3.0mmol/L)
The change in percentage time in hypoglycaemia(<3.0mmol/L) between baseline and intervention/control
Percentage time spent in hypoglycaemia (<3.9mmol/L)
The change in percentage time in hypoglycaemia (<3.9mmol/L) between baseline and intervention/control
Percentage time spent in hyperglycaemia (>10mmol/L)
The change in percentage time in hyperglycaemia (>10mmol/L) between baseline and intervention/control

Full Information

First Posted
March 21, 2023
Last Updated
September 8, 2023
Sponsor
Imperial College London
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1. Study Identification

Unique Protocol Identification Number
NCT05795309
Brief Title
Automated Insulin Delivery in Type 1 Diabetes Complicated by Gastroparesis
Acronym
AIDgastro
Official Title
Automated Insulin Delivery in Type 1 Diabetes Complicated by Gastroparesis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 16, 2023 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroparesis, Type 1 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Staggered randomised control trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hybrid Automated Insulin Delivery
Arm Type
Experimental
Arm Description
The intervention is the Medtronic 780G Hybrid Automated Insulin Delivery system
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
The control is Standard Care with real-time CGM
Intervention Type
Device
Intervention Name(s)
Hybrid Automated Insulin Delivery
Other Intervention Name(s)
Medtronic 780G
Intervention Description
Consists of an insulin pump and real-time continuous glucose monitoring (CGM)
Primary Outcome Measure Information:
Title
Percentage time spent in glucose target (3.9-10mmol/L)
Description
The change in percentage time in glucose target between baseline and intervention/control
Time Frame
4 - 8 weeks
Secondary Outcome Measure Information:
Title
Percentage time spent in hypoglycaemia (<3.0mmol/L)
Description
The change in percentage time in hypoglycaemia(<3.0mmol/L) between baseline and intervention/control
Time Frame
4 - 8 weeks
Title
Percentage time spent in hypoglycaemia (<3.9mmol/L)
Description
The change in percentage time in hypoglycaemia (<3.9mmol/L) between baseline and intervention/control
Time Frame
4 - 8 weeks
Title
Percentage time spent in hyperglycaemia (>10mmol/L)
Description
The change in percentage time in hyperglycaemia (>10mmol/L) between baseline and intervention/control
Time Frame
4 - 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Monika Reddy, PhD
Phone
+44 (0)20 7594 1796
Email
m.reddy@imperial.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Nick Oliver, FRCP
Phone
+44 (0)20 7594 1796
Email
nick.oliver@imperial.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nick Oliver
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imperial College London and Imperial College Healthcare NHS Trust
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monika Reddy
Phone
+44 (0)20 7594 1796
Email
m.reddy@imperial.ac.uk
First Name & Middle Initial & Last Name & Degree
Nick Oliver
Phone
+44 (0)20 7594 1796
Email
nick.oliver@imerial.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Automated Insulin Delivery in Type 1 Diabetes Complicated by Gastroparesis

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