Continuous Monitoring of Glycemic Variability to Predict Dys- and Hyperglycemia in Asymptomatic Type 1 Diabetes

Type1 Diabetes Mellitus Clinical Trial

Official title:

Continuous Monitoring of Glycemic Variability to Predict Dys- and Hyperglycemia in Asymptomatic Type 1 Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05777330
• Other study ID #: PredicT1D
• Status: Recruiting
• Phase: N/A
• Start date: August 9, 2023
• Est. completion date: April 2027

Study information

• Verified date: August 2023
• Source: Universitair Ziekenhuis Brussel
• Contact: Belgian Diabetes Registry
• Phone: 02 477 45 46
• Email: contact[@]bdronline.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this longitudinal clinical trial is to measure variability of interstitial glucose levels with a user-friendly real-time continuous glucose monitoring (CGM) technology at regular intervals in normo- and dysglycemic multiple autoantibody-positive first-degree relatives (age 5-39 years) of type 1 diabetes patients, in comparison with single autoantibody-positive relatives in the same age range. Participants will asked to undergo repeated oral glucose tolerance tests (OGTTs) (age 5-39 years) and hyperglycemic clamp tests (age 12-39 years) in parallel for a period of at least 2-3 years. In case of confirmed dysglycemia, we propose to perform CGM and OGTT every 3 months.

The main questions the study aims to answer are:

1. Do the amplitude and time trends of CGM-derived glycemic variability indices and OGTT- and clamp-derived variables differ between the intermediate, high and very high risk groups?

2. Can (changes in) CGM-derived glycemic variability indices predict/detect dysglycemia in initially normoglycemic (single or multiple autoantibody-positive) relatives with the same diagnostic efficiency as OGTT- or clamp-derived variables?

3. Can (changes in) CGM-derived glycemic variability indices predict clinical onset in (stage 1 or 2) multiple autoantibody-positive relatives with the same diagnostic efficiency as OGTT- or clamp-derived variables?

4. Can correlating (changes in) CGM-derived indices with (changes in) OGTT- and clamp-derived variables help to better understand the sequence of events leading to dysglycemia and clinical onset, as well as the relative contribution of beta cell function and insulin action to glycemic variability according to disease stage and biological and phenotypical characteristics of the relatives?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: April 2027
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 39 Years

Eligibility

Inclusion Criteria:

1. aged 5-39 years at inclusion;

2. being a sibling, offspring or parent of a patient with confirmed auto-immune type 1 diabetes;

3. absence of diabetes according to American Diabetes Association (ADA) criteria;

4. persistently positive for one or multiple types of autoantibodies among IAA, GADA, IA-2A and ZnT8A.

Exclusion Criteria:

1. Pregnancy or lactation in women; <6 months postpartum

2. Diabetes according to ADA criteria;

3. Use of illicit drugs, or overconsumption of alcohol, or history of drug or alcohol abuse;

4. Being legally incapacitated, having significant emotional problems at the time of the study, or having a history of psychiatric disorders;

5. Treatment with immune modulating or diabetogenic medication (e.g. corticosteroids) or medication that act to lower glycemia (oral antidiabetics) or agents that may influence insulin sensitivity or secretion;

6. Gastric bypass or banding;

7. History of acute or chronic pancreatitis, or (partial) pancreatectomy

8. History of any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risks to the subjects.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Hyperglycemia
• Type1 Diabetes Mellitus

Intervention

Diagnostic Test:
• Oral glucose tolerance test (OGTT)
Longitudinal study using repeated OGTT, CGM and hyperglycemic clamp tests to evaluate glycemic variability, beta cell function and insulin action in first-degree relatives at moderate, high and very high risk of clinical onset of type 1 diabetes. OGTT is performed every 6 months (every 3 months in case of dysglycemia) in all participants.
• Hyperglycemic clamp test
Longitudinal study using repeated OGTT, CGM and hyperglycemic clamp tests to evaluate glycemic variability, beta cell function and insulin action in first-degree relatives at moderate, high and very high risk of clinical onset of type 1 diabetes. Clamp test is performed every 12 months in single autoantibody-positive participants and every 6 months in multiple autoantibody-positive participants. Clamp tests are not performed in participants aged between 5-11 years.
• Continuous glucose monitoring
Longitudinal study using repeated OGTT, CGM and hyperglycemic clamp tests to evaluate glycemic variability, beta cell function and insulin action in first-degree relatives at moderate, high and very high risk of clinical onset of type 1 diabetes. A 10-day CGM recording is performed every 6 months (every 3 months in case of dysglycemia) in all participants.

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Antwerpen	Antwerpen
Belgium	Universitair Ziekenhuis Gent	Gent
Belgium	Universitair Ziekenhuis Brussel	Jette
Belgium	Universitair Ziekenhuis Leuven	Leuven
Belgium	Clinique CHC MontLégia	Liège

Sponsors (3)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel	Juvenile Diabetes Research Foundation, Vrije Universiteit Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression to persistent dysglycemia	In initially normoglycemic (single or multiple) autoantibody-positive relatives	2-3 years
Primary	Progression to persistent dysglycemia and stage 3 type 1 diabetes	In all multiple autoantibody-positive relatives	2-3 years