- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03945747
MEtabolic and Renal Effects of AutoMAted Insulin Delivery Systems in Youth With Type 1 Diabetes Mellitus (MERMAID-T1D)
MEtabolic and Renal Effects of AutoMAted Insulin Delivery Systems in Youth With Type 1 Diabetes Mellitus (MERMAID-T1D)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background: Over 1.25 million Americans have type 1 diabetes mellitus (T1DM), significantly increasing the risk of early death from cardio-renal disease. Per the American Diabetes Association, only 14% of children with T1DM meet glycemic targets [Wood et al. Diabetes Care 2013; 36:2035-37]. This is a severe and pervasive problem, as a child diagnosed with T1DM today is expected to live up to 17 years less than non-diabetic peers. It is established that time outside of goal glycemic target range increases the likelihood of developing micro- and macro-vascular diabetic complications including diabetic kidney disease (DKD) and cardiovascular disease (CVD). However, metabolic risk factors beyond glycemic control including insulin resistance and obesity are also increasingly recognized to contribute to the increased risk of DKD and CVD. Automated insulin delivery (AID) systems such as the hybrid closed loop artificial pancreas (HCL AP) combine use of an insulin pump, continuous glucose monitor (CGM), and a control algorithm to adjust background insulin delivery to improve time in target range. AID systems such as the predictive low glucose suspend (PLGS) system pause insulin delivery to try to reduce hypoglycemia. AID systems are now seeing markedly increased commercial use; however, the long-term effects on insulin sensitivity, body mass index (BMI), cardio-metabolic markers, and kidney function have not yet been studied. Preliminary basic science research suggests that periods of rest from insulin exposure provided by AID systems may have positive effects on DKD and CVD risk. In this proposal we intend to investigate the gap in knowledge between glycemic changes seen with AID systems and the impact on markers of long-term complications.
Specific Aims and Hypotheses:
Specific Aim 1: To examine the effects of the AID systems on glycemic control and insulin sensitivity as compared to traditional insulin pumps and multiple daily injections in youth with T1DM Hypothesis 1.1: Treatment with the AID systems improves glycemic control in youth with T1DM Hypothesis 1.2: Treatment with the AID systems increases insulin sensitivity and decreases insulin requirement in youth with T1DM
Specific Aim 2: To examine the effects of the AID systems on kidney function and metabolic markers as compared to traditional insulin pumps and multiple daily injections in youth with T1DM Hypothesis 2.1: Treatment with the AID systems improves metabolic markers in youth with T1DM Hypothesis 2.2: Treatment with the AID systems improves kidney function in youth with T1DM
Design: This study is a pilot study aimed at recruiting youth ages 7 to 18 years from the following 3 groups with T1DM: control participants on either multiple daily injections or conventional pump therapy, youth being transitioned to a HCL AP system, and youth being transitioned to a PLGS system. Exclusion criteria include non-T1DM, non-insulin blood glucose altering medications, pregnancy, breastfeeding, or a ketogenic diet. We plan to complete a physical exam with pubertal staging, collect information on recent insulin usage and dosages, fasting serum and urine samples, and a DXA scan before the participant transitions to either a HCL AP or a PLGS system, if applicable. Following 3-6 months of treatment we will then collect the identical data as at baseline. Outcome measures include CGM data, total daily insulin dose, time suspended from insulin delivery, height, weight, BMI, waist circumference, hip circumference, blood pressure, HbA1c, c-peptide, total cholesterol, HDL, LDL, triglycerides, adiponectin, and DXA scan to evaluate cardio-metabolic markers and calculate insulin sensitivity, as well as serum creatinine, cystatin c, copeptin, and urine microalbumin to evaluate kidney health and calculate GFR by Zappitelli and FAS equations.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Kalie L Tommerdahl, MD
- Phone Number: 720-777-5898
- Email: Kalie.Tommerdahl@childrenscolorado.org
Study Contact Backup
- Name: Kristen J Nadeau, MD, MS
- Phone Number: 720-777-2855
- Email: Kristen.Nadeau@childrenscolorado.org
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- Children's Hospital Colorado
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 7-18 years
- Type 1 diabetes with at least two of the following criteria: diabetes-associated antibody-positivity, rapid conversion to insulin requirement after diagnosis, absent c-peptide, or DKA at diagnosis
- Currently receiving insulin therapy by multiple daily injections or standard insulin pump therapy
Exclusion Criteria:
- Non-type 1 diabetes mellitus
- Pregnant or breastfeeding
- Receiving treatment with non-insulin glucose-altering medications including oral anti-hyperglycemic medications, steroids, or antipsychotics
- Following a ketogenic diet
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Control group
Individuals continue current treatment regimen with either standard insulin pump therapy or multiple daily insulin injections for the duration of the study.
|
Participants will undergo a blood collection for hemoglobin A1c, adiponectin, total cholesterol, LDL, HDL, triglycerides, and c-peptide at baseline and follow up in 3-6 months.
Participants will undergo urine sample collection for urine microalbumin and urine creatinine at baseline and follow up in 3-6 months.
Participants will undergo a DXA scan for lean and fat mass measurements at baseline and follow up in 3-6 months.
|
Hybrid closed-loop artificial pancreas system group
Individuals transition from either standard insulin pump therapy or multiple daily injections to a hybrid closed-loop system at the beginning of the study after initial labs and imaging studies are completed.
|
Participants will undergo a blood collection for hemoglobin A1c, adiponectin, total cholesterol, LDL, HDL, triglycerides, and c-peptide at baseline and follow up in 3-6 months.
Participants will undergo urine sample collection for urine microalbumin and urine creatinine at baseline and follow up in 3-6 months.
Participants will undergo a DXA scan for lean and fat mass measurements at baseline and follow up in 3-6 months.
|
Predictive low glucose suspend system group
Individuals transition from either standard insulin pump therapy or multiple daily injections to a predictive low glucose suspend system at the beginning of the study after initial labs and imaging studies are completed.
|
Participants will undergo a blood collection for hemoglobin A1c, adiponectin, total cholesterol, LDL, HDL, triglycerides, and c-peptide at baseline and follow up in 3-6 months.
Participants will undergo urine sample collection for urine microalbumin and urine creatinine at baseline and follow up in 3-6 months.
Participants will undergo a DXA scan for lean and fat mass measurements at baseline and follow up in 3-6 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in estimated insulin sensitivity
Time Frame: 3-6 months
|
Estimated by calculating the eIS, Pittsburgh eGDR, and SEARCH IS equations
|
3-6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in estimated glomerular filtration rate (GFR)
Time Frame: 3-6 months
|
Estimated by calculating the Zappitelli (CysCrEq) and eGFR-FAS (using serum creatinine) equations
|
3-6 months
|
Change in body mass index (BMI)
Time Frame: 3-6 months
|
Measured by evaluations of height and weight
|
3-6 months
|
Change in lipid profile
Time Frame: 3-6 months
|
Measured by fasting blood draw for total cholesterol, LDL, HDL, and triglycerides
|
3-6 months
|
Change in c-peptide
Time Frame: 3-6 months
|
Measured by fasting blood draw for c-peptide level
|
3-6 months
|
Change in DXA scan
Time Frame: 3-6 months
|
Evaluation of lean and fat mass by DXA scan
|
3-6 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Immune System Diseases
- Autoimmune Diseases
- Urologic Diseases
- Endocrine System Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Diabetes Mellitus
- Kidney Diseases
- Diabetes Mellitus, Type 1
- Diabetic Nephropathies
- Metabolic Diseases
- Diabetes Complications
Other Study ID Numbers
- 18-1558
- UL1TR002535 (U.S. NIH Grant/Contract)
- 5T32DK063687-15 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Diabetes Mellitus, Type 1
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
University of Colorado, DenverMassachusetts General Hospital; Beta Bionics, Inc.CompletedDiabetes Mellitus, Type 1 | Type 1 Diabetes | Diabetes type1 | Type 1 Diabetes Mellitus | Autoimmune Diabetes | Diabetes Mellitus, Insulin-Dependent | Juvenile-Onset Diabetes | Diabetes, Autoimmune | Insulin-Dependent Diabetes Mellitus 1 | Diabetes Mellitus, Insulin-Dependent, 1 | Diabetes Mellitus, Brittle | Diabetes Mellitus, Juvenile-Onset and other conditionsUnited States
-
University of California, San FranciscoJuvenile Diabetes Research FoundationCompletedType 1 Diabetes Mellitus | Diabetes Mellitus, Type I | Insulin-Dependent Diabetes Mellitus 1 | Diabetes Mellitus, Insulin-Dependent, 1 | IDDMUnited States, Australia
-
AstraZenecaCompletedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
Capillary Biomedical, Inc.TerminatedType 1 Diabetes | Type 1 Diabetes Mellitus | Diabetes Mellitus, Type I | Diabetes Mellitus, Insulin-Dependent, 1 | IDDMAustria
-
National Institute of Allergy and Infectious Diseases...PPD; Rho Federal Systems Division, Inc.; Immune Tolerance Network (ITN)CompletedType 1 Diabetes Mellitus | T1DM | T1D | New-onset Type 1 Diabetes MellitusUnited States, Australia
-
Shanghai Changzheng HospitalRecruitingBrittle Type 1 Diabetes MellitusChina
-
Capillary Biomedical, Inc.CompletedDiabetes Mellitus, Type 1 | Type 1 Diabetes | Type 1 Diabetes Mellitus | Diabetes Mellitus, Insulin-Dependent, 1Australia
-
Spiden AGDCB Research AGRecruitingType 1 Diabetes Mellitus | Type 1 Diabetes Mellitus With Hypoglycemia | Type 1 Diabetes Mellitus With HyperglycemiaSwitzerland
-
Hoffmann-La RocheRoche DiagnosticsCompletedDiabetes Mellitus Type 2, Diabetes Mellitus Type 1Germany
Clinical Trials on Blood draw
-
Abbott Point of CareNot yet recruitingPrecision of Potassium (K) Test in Capillary Whole Blood
-
University Hospital, Strasbourg, FranceNot yet recruitingKidney Transplantation | Humoral Rejection | Kidney Allograft Biopsy | Microvascular Inflammation
-
Vanderbilt-Ingram Cancer CenterWren Laboratories LLCCompletedMelanomaUnited States
-
Wyeth is now a wholly owned subsidiary of PfizerCompleted
-
Turtle Health, Inc.Completed
-
National Heart Centre SingaporeDuke-NUS Graduate Medical SchoolRecruiting
-
Duke UniversityNational Cancer Institute (NCI); National Institutes of Health (NIH)RecruitingHematologic MalignancyUnited States
-
University of BonnRecruitingSARS-CoV 2 | COVIDGermany
-
Joseph M. Still Research Foundation, Inc.RecruitingInflammatory Response | Deep Vein Thrombosis | Multi Organ Failure | Nosocomial InfectionUnited States