JCHR

Effect of Metabolic Control at Onset of Diabetes on Progression of Type 1 Diabetes

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The purpose of this study is to test the impact of intensive metabolic control from the onset of diabetes on preservation of C-peptide secretion. This study will also test the feasibility and acceptance of this therapy so that it could be considered in future immune intervention studies. The therapy consists of a short course of sub-cutaneous closed-loop diabetic control at the onset of diabetes followed by real-time continuous glucose monitoring (CGM) with use of an insulin pump. 

Following completion of the baseline procedures, participants are randomized to either the Intensive Treatment Group which includes a hospital admission for up to 4-6 days for inpatient closed loop therapy followed by outpatient use of an insulin pump and CGM or the Standard Treatment Group.

To take part in the study, T1DM subjects will need to have:

1. Age 6.0 to <46.0 years.
2. Diagnosis of type 1 diabetes with initiation of insulin therapy within past 7 days (day 1 being the first day of insulin therapy)
3. If participant is female with reproductive potential, willing to avoid pregnancy and pregnancy test negative.
4. Willing to accept randomization to either the intensive diabetes management group or the standard care group.
5. Willing to complete the planned 2 years of follow-up.
6. Able to electronically transmit data monthly.
7. Investigator believes that the participant (and parent/guardian for children) understands and agrees to comply with the study protocol and is capable of undertaking all necessary testing.
8. Not be currently pregnant or lactating, or anticipate getting pregnant in the next one year.
9. Not be currently anemic.
10. Not be taking a medication or have another disease that the investigator feels would prevent him or her from completing any aspect of the study.
11. Not have received inpatient psychiatric treatment in the past 6 months.
12. Not currently participating in another type 1 diabetes treatment study, including an intervention trial for treatment of diabetic ketoacidosis.

Study Procedures
On the day of enrollment, a hemoglobin A1c and autoantibodies samples will be obtained. An abbreviated Mixed Meal Tolerance Test will be administered and potential subjects will be evaluated for study eligibility through the elicitation of a medical history and performance of a physical examination by a study investigator.

Study subjects will be consented and randomized at the clinical sites as soon as possible after diagnosis of diabetes. The goal is to have randomization occur within 48 hours of diagnosis of diabetes; however, enrollment up to seven days after initiation of insulin therapy will be acceptable. Subjects admitted for treatment of DKA with IV insulin and fluids will be asked to consent to the study and will be randomized before their first meal. Subjects who were diagnosed as an outpatient and did not necessarily require hospital admission will come to the CRC for a morning admission for a mixed meal tolerance test, and will be randomized at the time of that admission.

Subjects will be randomly assigned to one of two treatment groups:

 If assigned to Standard Treatment, the subject will:

• Start insulin therapy (this may take place at the clinical site or hospital, depending on the physician's recommendation).
• At home, check blood sugars 4 or more times a day using a blood glucose meter.
• Wear a blinded CGM for 3 days following visits every 3 months for the first 2 years and every 6 months during the last 2 years if they are continuing to produce insulin. 

If assigned to Intensive Treatment, which is not usually prescribed to patients who have been recently diagnosed with type 1 diabetes because it is not certain whether this much effort will be helpful, the patient will:

• Stay in the hospital for 4 to 6 days, during which an insulin pump, continuous glucose monitor, and computer to control glucose levels will be used.
• Keep using an insulin pump and continuous glucose monitor at home for two years.
• At home, check blood sugars 4 or more times a day using a blood glucose meter.

 All participants will be seen for follow-up visits at 2 weeks, 6 weeks, 3 months and then every 3 months for 2 years. If at the end of two years the participant is continuing to produce insulin, he or she will be asked to return for additional visits every 6 months for an additional 2 years.

The following procedures will be completed at each follow-up visit:

• History, including recording of medications and adverse events
• Physical exam (full exam at annual visits and limited/directed exam at other visits)
• Urine pregnancy test (for females with reproductive potential) at the 12-month visit and anytime a period is missed
• Blood sample for local HbA1c assessment at all visits except 2 weeks
• Blood sample for central laboratory HbA1c assessment at all visits beginning with the 3-month visit (except the visits at 15 and 21 months)
• Blood samples for autoantibodies, PBMC, RNA and extra plasma and serum to be stored for possible future analyses
• Mixed Meal Tolerance Test (except the visits at 15 and 21 months)
• Download study devices

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