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Modeling Ketosis-Prone Diabetes Remission Via Diverse Mechanisms of Glucotoxicity

ConditionKetosis Prone Diabetes
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorEmory University

About this trial

The goal of this study is to quantify day-to-day changes in blood glucose during treatment towards remission in ketosis-prone diabetes (KPDM) and describe them using a mathematical model of KPDM pathogenesis and remission.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Provide informed consent

Have a BMI ≥ 28 kg/m2

Be of African American ancestry

Meet diagnostic criteria for DKA. Diagnostic criteria for DKA will include a plasma glucose > 250 mg/dl, a venous pH < 7.30, a serum bicarbonate < 18 mmol/l, and serum ketones (beta-hydroxy butyrate) > 1.5 mmol/L.

Disqualifiers

Significant medical or surgical illness including but not limited to myocardial ischemia, congestive heart failure, chronic peripheral venous insufficiency, chronic renal insufficiency, liver insufficiency (serum transaminases 3 times the upper limit of normal) and acute or chronic infectious processes

Have recognized uncontrolled endocrine disorders such as hypercortisolism, acromegaly, or hyperthyroidism

Anemia (hemoglobin < 12.5 g/dL for men, <11.5 gm/dL for women), bleeding disorders, or abnormalities in coagulation studies

Pregnant

Trial design

Design model

Single group

Treatments tested in this trial

  • Continuous Glucose Monitoring

    Device

    After insulin discontinuation participants continue wearing their CGMs, for a total of 3 months.

  • Insulin

    Drug

    Participants will receive standard-of-care insulin treatment. Insulin dosing will be adjusted based on CGM glucose readings.

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: Continuous Glucose Monitoring with Adjusted Insulin DosesExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Quantify Changes in Blood Glucose

The day-to-day changes in blood glucose in KPDM will be quantified using CGMs.

Time frame
Up to 3 months
2

Development of Mathematical Models

The study team will adapt and develop mathematical models to describe the course of KPDM remission in each individual patient, i.e. the entire range of variation within the group of 12 participants.

Time frame
Up to 3 months

Secondary outcomes

1

Correlation of Fit With Model Parameters and Duration of Remission

The study team will validate mathematical models to predict duration of remission.

Time frame
Up to 3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Emory University

Lead sponsor

Source ClinicalTrials.gov
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