Automated Insulin Delivery in Type 1 Diabetes Complicated by Gastroparesis

Type 1 Diabetes Clinical Trial

— AIDgastro  

Official title:

Automated Insulin Delivery in Type 1 Diabetes Complicated by Gastroparesis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05795309
• Other study ID #: 22HH8008
• Status: Recruiting
• Phase: N/A
• Start date: August 16, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: September 2023
• Source: Imperial College London
• Contact: Monika Reddy, PhD
• Phone: +44 (0)20 7594 1796
• Email: m.reddy[@]imperial.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Gastroparesis
• Type 1 Diabetes

Intervention

Device:
• Hybrid Automated Insulin Delivery
Consists of an insulin pump and real-time continuous glucose monitoring (CGM)

Locations

Country	Name	City	State
United Kingdom	Imperial College London and Imperial College Healthcare NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage time spent in glucose target (3.9-10mmol/L)	The change in percentage time in glucose target between baseline and intervention/control	4 - 8 weeks
Secondary	Percentage time spent in hypoglycaemia (<3.0mmol/L)	The change in percentage time in hypoglycaemia(<3.0mmol/L) between baseline and intervention/control	4 - 8 weeks
Secondary	Percentage time spent in hypoglycaemia (<3.9mmol/L)	The change in percentage time in hypoglycaemia (<3.9mmol/L) between baseline and intervention/control	4 - 8 weeks
Secondary	Percentage time spent in hyperglycaemia (>10mmol/L)	The change in percentage time in hyperglycaemia (>10mmol/L) between baseline and intervention/control	4 - 8 weeks