How effective is intense therapy if started within seven days of diagnosing T1DM?…
Preserving the function of any beta cells left in type 1 diabetes patients is a big goal in diabetes care. This study attempted to assess if starting an intensive therapy within seven days of a type 1 diagnosis could preserve beta cell function better than the standard of care approach at one year. The primary outcome was C-peptide concentrations.
There were 68 participants in the study diagnosed with T1DM who had started insulin therapy within seven days of diagnosis: 48 participants were randomly assigned to the intensive therapy group and 20 were randomly assigned to the standard care group.
Intensive treatment involved hybrid closed-loop control (HCLC) for at least 72 hours as an inpatient. While using the HCLC the glucose set point was 110 to 120mg/dl. Carbohydrates were counted for meals and 20 minutes prior to meals, a bolus dose was given. Upon discharge, participants were instructed to use a sensor augmented pump (SAP) as an outpatient for the rest of the year. Patients were expected to use the sensor pump and continuous glucose monitor daily. The standard of care used in practice for newly diagnosed T1DM involves insulin treatment with frequent calls to adjust treatments. The goal of treatment was to maintainHbA1c and glucose levels as close to normal as possible. Both groups were scheduled to have follow-ups at assigned intervals.
The C-peptide in the intensive therapy group was 0.43 pmol/min (95% CI, 0.34-0.52) versus 0.52 (95%CI, 0.32-0.75) in the standard care group. C-peptide remained similar throughout all follow-up visits. HbA1c levels also remained similar in both groups. At 1 year the mean A1C was 7.4 ± 1.2% for intensive therapy and 7.3 ± 1.1% for standard care. Mean total daily insulin doses also remained similar with intensive therapy being 0.6 ± 0.2 units/kg/day and standard care being 0.6 ±0.3 units/kg/day. BMI percentile was 58 for intensive and 62 for standard. A hypoglycemic episode requiring glucagon occurred in one patient while receiving intensive therapy compared to none in the standard care group.
The authors suggested that inconclusive benefit was likely due to several factors including the fact that the sample size was relatively small. Another factor was that by 12 months only 33% of the intensive therapy patients were using the controlled glucose monitor they were assigned to use daily. Both groups also had good glycemic control over the 12 month period. They suggest that because of these limitations, the results do not necessarily refute the hypothesis.
- The HLCL system "consists of a subcutaneous glucose sensor and insulin pump which communicated wirelessly with a bedside computer running a proportional-integral-derivative algorithm" similar to an artificial pancreas.
- A sensor-augmented pump combines an insulin pump with a continuous glucose sensor.
- C-peptide is a byproduct created when insulin is produced. By measuring C-peptide, one can determine the functionality of beta cells which produce insulin.
Buckingham, B. et al. Effectiveness of Early Intensive Therapy on Beta-Cell Preservation in Type 1 Diabetes. Diabetes Care 36:4030-4035, 2013