Back to resultsA Pilot Study to Assess the Feasibility of a Novel Non-invasive Technology to Measure Changing Blood Glucose Levels in Adults With Type-1 Diabetes Mellitus
Primary Purpose
Type 1 Diabetes Mellitus, Type 1 Diabetes Mellitus With Hypoglycemia, Type 1 Diabetes Mellitus With Hyperglycemia
Status
Not yet recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Lab Demo 1.0
Sponsored by
About this trial
This is an interventional device feasibility trial for Type 1 Diabetes Mellitus focused on measuring Hypoglycemia, Hyperglycemia, Diabetes, Transcutaneous, Spectral fingerprint, Noninvasive
Eligibility Criteria
Inclusion Criteria: 1.1nformed Consent signed by the subject 1.2 Male and female subjects 18 - 60 years of age (inclusive) 1.3 Skin colour Type I, II, or III according to Fitzpatrick Scale (see Appendix 1) 1.4 Type 1 diabetes diagnosed > 12 months ago 1.5 Intensified insulin therapy scheme using multiple daily injection (MDI) or continuous subcutaneous insulin infusion (CSII) for more than 6 months 1.6 BMI between 18.5 and 28.0 kg/m2 1.7 Using a CGM/FGM system (Freestyle Libre2, Freestyle Libre3, Dexcom G6 or Dexcom G7) 1.8 Willingness to follow the study procedure Exclusion Criteria: 2.1 In female subjects: pregnancy or breastfeeding period (self-reported) 2.2 HbA1c of > 9.0% (based on last measurement by treating physician but not older than 120 days) Note: To be repeated at the study site if measurement is older than 120 days or not available 2.3 History of cardiovascular diseases 2.4 Irregular 12-lead ECG upon investigator's judgement 2.5 Medical history of epilepsy or other neurological disease associated with seizure events 2.6 Atypical skin condition (e.g., Hyperkeratosis, Hyperpigmentation) or presence of tattoos or scars in the measurement area (wrist) that could impair validity of measurement upon investigator's judgement 2.7 Known sensitivity to medical grade adhesives or other skin-related complications, which might influence the outcome 2.8 Not able to understand, write or read German 2.9 Participation in another investigation with an investigational drug within the 30 days preceding and during the present investigation 2.10 Enrolment of the PI, his/her family members, employees and other dependent persons
Sites / Locations
- Markus Laimer
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Investigational arm
Arm Description
Induction of different glycaemia states via intravenous regular insulin and intravenous glucose administration and measurements of transcutaneous spectral data with the investigational device and reference blood glucose values.
Outcomes
Primary Outcome Measures
Changes in spectral fingerprints measured by the Lab Demo 1.0 at fluctuations of venous blood glucose levels
The primary outcome is to assess the feasibility/capacity of the prototype device to measure changes in spectral fingerprints at fluctuations of venous blood glucose levels in ranges of hypoglycaemic and hyperglycaemic states.
Secondary Outcome Measures
Changes in spectral fingerprints measured by the Lab Demo 1.0 at fluctuations of interstitial fluid glucose levels
The secondary outcome is to assess the feasibility/capacity of the prototype device to measure changes in spectral fingerprints at fluctuations of interstitial fluid glucose levels in ranges of hypoglycaemic and hyperglycaemic states.
Spectral fingerprints measured by the Lab Demo 1.0
This secondary objective consists of describing the spectral fingerprints at different blood glucose levels (defined by both venous blood glucose and interstitial fluid glucose)
Blood glucose levels
Blood glucose levels at the time of changes in spectral fingerprints measured by the Lab Demo 1.0
Heart rate
Heart rate at the time of changes in spectral fingerprints measured by the Lab Demo 1.0
Oxygen saturation
Oxygen saturation at the time of changes in spectral fingerprints measured by the Lab Demo 1.0
Full Information
NCT ID
NCT06097689
First Posted
October 10, 2023
Last Updated
October 23, 2023
Sponsor
Spiden AG
Collaborators
DCB Research AG
1. Study Identification
Unique Protocol Identification Number
NCT06097689
Brief Title
A Pilot Study to Assess the Feasibility of a Novel Non-invasive Technology to Measure Changing Blood Glucose Levels in Adults With Type-1 Diabetes Mellitus
Official Title
A Pilot Study to Assess the Feasibility of a Novel Non-Invasive Technology to Measure Glucose Dynamics in Adults Living With Type 1 Diabetes Mellitus: A Single-Arm Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 8, 2023 (Anticipated)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spiden AG
Collaborators
DCB Research AG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary aim of this study is to assess the feasibility of the Lab demo 1.0 and associated computational models to detect and track glucose changes noninvasively and transcutaneously in defined and dynamic states of glycemia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus, Type 1 Diabetes Mellitus With Hypoglycemia, Type 1 Diabetes Mellitus With Hyperglycemia
Keywords
Hypoglycemia, Hyperglycemia, Diabetes, Transcutaneous, Spectral fingerprint, Noninvasive
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Investigational arm
Arm Type
Experimental
Arm Description
Induction of different glycaemia states via intravenous regular insulin and intravenous glucose administration and measurements of transcutaneous spectral data with the investigational device and reference blood glucose values.
Intervention Type
Device
Intervention Name(s)
Lab Demo 1.0
Intervention Description
Lowering of the participants blood glucose with the application of insulin to induce hypoglycaemia, followed by the application of glucose to induce hyperglycaemia and finally insulin to restore euglycemia.
During the different glycaemia states, transcutaneous spectral data are collected continuously with the device and paired with reference measurements (venous blood and interstitial fluid).
Primary Outcome Measure Information:
Title
Changes in spectral fingerprints measured by the Lab Demo 1.0 at fluctuations of venous blood glucose levels
Description
The primary outcome is to assess the feasibility/capacity of the prototype device to measure changes in spectral fingerprints at fluctuations of venous blood glucose levels in ranges of hypoglycaemic and hyperglycaemic states.
Time Frame
The data is collected during the study procedure (6 to 8 hours)
Secondary Outcome Measure Information:
Title
Changes in spectral fingerprints measured by the Lab Demo 1.0 at fluctuations of interstitial fluid glucose levels
Description
The secondary outcome is to assess the feasibility/capacity of the prototype device to measure changes in spectral fingerprints at fluctuations of interstitial fluid glucose levels in ranges of hypoglycaemic and hyperglycaemic states.
Time Frame
The data is collected during the study procedure (6 to 8 hours)
Title
Spectral fingerprints measured by the Lab Demo 1.0
Description
This secondary objective consists of describing the spectral fingerprints at different blood glucose levels (defined by both venous blood glucose and interstitial fluid glucose)
Time Frame
The data is collected during the study procedure (6 to 8 hours)
Title
Blood glucose levels
Description
Blood glucose levels at the time of changes in spectral fingerprints measured by the Lab Demo 1.0
Time Frame
During the study procedure (6 to 8 hours)
Title
Heart rate
Description
Heart rate at the time of changes in spectral fingerprints measured by the Lab Demo 1.0
Time Frame
During the study procedure (6 to 8 hours)
Title
Oxygen saturation
Description
Oxygen saturation at the time of changes in spectral fingerprints measured by the Lab Demo 1.0
Time Frame
During the study procedure (6 to 8 hours)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
1.1nformed Consent signed by the subject
1.2 Male and female subjects 18 - 60 years of age (inclusive)
1.3 Skin colour Type I, II, or III according to Fitzpatrick Scale (see Appendix 1)
1.4 Type 1 diabetes diagnosed > 12 months ago
1.5 Intensified insulin therapy scheme using multiple daily injection (MDI) or continuous subcutaneous insulin infusion (CSII) for more than 6 months
1.6 BMI between 18.5 and 28.0 kg/m2
1.7 Using a CGM/FGM system (Freestyle Libre2, Freestyle Libre3, Dexcom G6 or Dexcom G7)
1.8 Willingness to follow the study procedure
Exclusion Criteria:
2.1 In female subjects: pregnancy or breastfeeding period (self-reported)
2.2 HbA1c of > 9.0% (based on last measurement by treating physician but not older than 120 days) Note: To be repeated at the study site if measurement is older than 120 days or not available
2.3 History of cardiovascular diseases
2.4 Irregular 12-lead ECG upon investigator's judgement
2.5 Medical history of epilepsy or other neurological disease associated with seizure events
2.6 Atypical skin condition (e.g., Hyperkeratosis, Hyperpigmentation) or presence of tattoos or scars in the measurement area (wrist) that could impair validity of measurement upon investigator's judgement
2.7 Known sensitivity to medical grade adhesives or other skin-related complications, which might influence the outcome
2.8 Not able to understand, write or read German
2.9 Participation in another investigation with an investigational drug within the 30 days preceding and during the present investigation
2.10 Enrolment of the PI, his/her family members, employees and other dependent persons
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie-Aline Gérard, PhD
Phone
0782049811
Ext
+41
Email
marie-aline.gerard@dcberne.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabien Rebeaud, PhD
Organizational Affiliation
Spiden AG
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Markus Laimer, Prof Dr med
Organizational Affiliation
University Department of Diabetology, Endocrinology, Nutritional Medicine & Metabolism (UDEM), Inselspital, Bern University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Markus Laimer
City
Berne
ZIP/Postal Code
3010
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Markus Laimer, Prof Dr med
Phone
0316324070
Ext
+41
Email
Markus.Laimer@insel.ch
First Name & Middle Initial & Last Name & Degree
Markus Laimer, Prof Dr med
12. IPD Sharing Statement
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A Pilot Study to Assess the Feasibility of a Novel Non-invasive Technology to Measure Changing Blood Glucose Levels in Adults With Type-1 Diabetes Mellitus
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